Comparative Effectiveness of Two Treatments for Veterans With PTSD
Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT02586064
Collaborator
Georgetown University (Other), Southeast Louisiana Veterans Health Care System (U.S. Fed)
115
2
2
42.9
57.5
1.3
Study Details
Study Description
Brief Summary
Interpersonal problems such as relationship conflict and social isolation are common among Veterans with PTSD and serve as barriers to successful posttraumatic adjustment. The main interventions for PTSD at VA facilities, i.e., Prolonged Exposure, Cognitive Processing Therapy, and Trauma-Focused CBT, do not directly target these relationship difficulties and many Veterans do not complete these treatments. Couple and family approaches for PTSD address relationship problems, but logistical problems make it difficult for couples to attend sessions and these approaches do not involve Veterans who are socially isolated or unmarried. There is accumulating evidence that Interpersonal Psychotherapy (IPT) for PTSD may be effective in reducing symptoms and improving interpersonal functioning. This study, a randomized controlled trial, aims to provide evidence regarding whether IPT for PTSD could be a useful addition to current treatments delivered at the VA.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The strong relationship between posttraumatic stress disorder (PTSD) and interpersonal problems is well documented. PTSD is highly associated with relationship discord, increased intimate partner violence, and difficulties in connecting with others, leading to social isolation. These types of conflicts, as well as the social withdrawal that is common among Veterans with PTSD, diminish the Veteran's opportunities for interaction with supportive others, and serve as a barrier to successful posttraumatic adjustment. Treatments that have been "rolled out" nationally in VAMCs, e.g., Prolonged Exposure, Cognitive Processing Therapy, and Trauma-Focused CBT, do not directly target these relationship difficulties. Furthermore, data show that only a limited number of Veterans has fully engaged with these interventions. Evidence-based interventions of couples therapy are available, but are not logistically feasible for many couples and do not address the problems of those who are socially isolated. This application proposes a randomized clinical trial of Interpersonal Psychotherapy (IPT-PTSD) as a treatment for Veterans with PTSD and relationship problems. Pilot data suggest that this type of treatment may provide a useful alternative strategy for Veterans who would prefer an individual, relationship-focused approach. The investigators propose comparing IPT-PTSD with Prolonged Exposure (PE), an evidence based treatment for PTSD used in the VHA system. The investigators hypothesize that IPT-PTSD will be statistically equivalent to PE in reducing PTSD symptom severity, and superior to PE in improving interpersonal functioning. IPT-PTSD is also hypothesized to be more effective than PE in improving social adjustment and quality of life. Exploratory analyses will examine whether IPT-PTSD is more effective than PE in reducing suicidal ideation, and will examine hypothesized mediators of improvement in PTSD symptoms in IPT-PTSD.
Study Design
Study Type:
Interventional
Actual Enrollment
:
115 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Interpersonal Therapy for Veterans With PTSD
Actual Study Start Date
:
Sep 1, 2016
Actual Primary Completion Date
:
Mar 31, 2020
Actual Study Completion Date
:
Mar 31, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Interpersonal Psychotherapy for PTSD Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions |
Behavioral: Interpersonal Therapy for PTSD
Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.
|
| Active Comparator: Prolonged Exposure Exposure based intervention including exposure to memories and avoided places and activities |
Behavioral: Prolonged Exposure
Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).
|
Outcome Measures
Primary Outcome Measures
- Change in Clinician Administered PTSD Scale (CAPS-5) [Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks]
Structured interview for assessment of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome.
- Change in Inventory of Interpersonal Functioning (IIP-32) [Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks]
Self-report measure of Veterans' interpersonal difficulties. Scores range from a minimum value of 0 to a maximum value of 128, higher scores mean a worse outcome.
Secondary Outcome Measures
- Change in PTSD Checklist for DSM-5 Military Version (PCL-M) [Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks]
Self report measure of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome.
- Change in Patient Health Questionnaire (PHQ) [Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks]
Self report measure of mood and anxiety symptoms. Scores range from a minimum value of 0 to a maximum value of 27, higher scores mean a worse outcome.
- Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other [Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks]
Self-report measure of a participant's subjective social support with regards to a participant's significant other. For each subscale, the mean of items is reported therefore for the Significant Other Subscale: Sum across items 1, 2, 5, & 10, then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome.
- Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family [Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks]
Self-report measure of a participant's subjective social support with regards to a participant's family. For each subscale, the mean of items is reported therefore for the Family Subscale: Sum across items 3, 4, 8, & 11 then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome.
- Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends [Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks]
Self-report measure of a participant's subjective social support with regards to a participant's family. For each subscale, the mean of items is reported therefore for the Friends Subscale: Sum across items 6, 7, 9, & 12 then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome.
- Change in Concise Health Risk Tracking Scale - Total (CHRT) [Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks]
Self report measure of suicidal ideation and related symptoms. Our study used a response scale of 1 to 5. The CHRT has 12 items, and the total score has a possible range of 12 to 60. Higher scores indicate more suicidal ideation and risk.
- Change in Concise Health Risk Tracking Scale (CHRT) - Propensity [Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks]
The propensity subscale score includes 9 items assessing, hopelessness, self-worth and perceived social support, and the possible range for our study is 9 to 45 Higher scores indicate worse outcome.
- Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts [Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks]
The CHRT Suicidal Thoughts subscale includes 3 items and has a possible range in our study from 3 to 15. Higher scores indicate higher suicidal thoughts.
- Change in Work and Social Adjustment Scale (WSAS) [Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks]
Self report measure of functional impairment in five areas of functioning (work, home management, social leisure, personal leisure, close relationships. Scores range from a minimum value of 0 to a maximum value of 40, higher scores mean a worse outcome.
- Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life [Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks.]
Measure of four domains related to quality of life: physical health, psychological, social relationships and environment. Data presented from Item 1 (Quality of Life) Scores range from a minimum value of 1 to a maximum value of 5, lower scores mean a worse outcome.
- Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health [Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks.]
Measure of four domains related to quality of life: physical health, psychological, social relationships and environment. Data presented from Item 2 (Satisfaction with Health). Scores range from a minimum value of 1 to a maximum value of 5, lower scores mean a worse outcome.
- GAD - 7 Generalized Anxiety Disorder [Baseline to 6 months posttreatment]
Measure of generalized anxiety amongst participants over time. Scores range from a minimum value of 0 to a maximum value of 21, higher scores mean a worse outcome.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Veterans age 18 or older
-
Experienced trauma while deployed to a war zone
-
Meet DSM-5 criteria for PTSD and a minimum CAPS-5 score of 23
-
Have at least one area of relationship dysfunction
-
Consent to be randomized
Exclusion Criteria:
-
Current severe substance use disorder
-
Current psychotic symptoms
-
Current mania or un-medicated Bipolar Disorder
-
Imminent threat of suicide or homicide
-
Victim or perpetrator of severe domestic violence in the past 12 months
-
Currently receiving Cognitive Behavioral Therapy for PTSD
-
Psychotropic medication start or dosage change within the prior 4 weeks
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Southeast Louisiana Veterans Health Care System, New Orleans, LA | New Orleans | Louisiana | United States | 70112 |
| 2 | Providence VA Medical Center, Providence, RI | Providence | Rhode Island | United States | 02908 |
Sponsors and Collaborators
- VA Office of Research and Development
- Georgetown University
- Southeast Louisiana Veterans Health Care System
Investigators
- Principal Investigator: Tracie M. Shea, PhD, Providence VA Medical Center, Providence, RI
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02586064
Other Study ID Numbers:
- D1783-R
- I01RX001783
First Posted:
Oct 26, 2015
Last Update Posted:
Jul 7, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | IPT-PTSD | Prolonged Exposure |
|---|---|---|
| Arm/Group Description | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination. | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). |
| Period Title: Overall Study | ||
| STARTED | 61 | 54 |
| COMPLETED | 43 | 26 |
| NOT COMPLETED | 18 | 28 |
Baseline Characteristics
| Arm/Group Title | IPT-PTSD | Prolonged Exposure | Total |
|---|---|---|---|
| Arm/Group Description | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination. | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). | Total of all reporting groups |
| Overall Participants | 58 | 51 | 109 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
47
(16)
|
52
(15)
|
49
(16)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
3
5.2%
|
3
5.9%
|
6
5.5%
|
| Male |
55
94.8%
|
48
94.1%
|
103
94.5%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| White |
39
67.2%
|
31
60.8%
|
70
64.2%
|
| Black |
14
24.1%
|
17
33.3%
|
31
28.4%
|
| Other |
5
8.6%
|
3
5.9%
|
8
7.3%
|
| Clinician Assessment of PTSD Symptoms Version 5 (CAPS-5) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
36.3
(7.2)
|
34.8
(7.4)
|
35.6
(7.3)
|
| PTSD Checklist Military Version 5 (PCL-M-5) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
48.0
(13.1)
|
45.8
(12.7)
|
47.6
(12.9)
|
| Inventory of Interpersonal Functioning (IIP-32) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
1.53
(0.64)
|
1.43
(0.56)
|
1.48
(0.60)
|
| Patient Health Questionnaire (PHQ-9) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
15.2
(6.4)
|
13.0
(7.3)
|
14.2
(6.9)
|
| Generalized Anxiety Disorder (GAD-7) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
12.1
(5.8)
|
11.6
(6.2)
|
11.9
(6.0)
|
| Multidimensional Scale of Perceived Social Support (MSPSS - Significant Other) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
4.9
(1.9)
|
5.5
(1.2)
|
5.2
(1.6)
|
| Multidimensional Scale of Perceived Social Support (MSPSS) - Family (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
3.9
(1.8)
|
4.6
(1.7)
|
4.2
(1.8)
|
| Multidimensional Scale of Perceived Support (MSPSS) - Friends (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
3.9
(1.6)
|
4.1
(1.5)
|
4.0
(1.6)
|
| Concise Health Risk Tracking (CHRT) Scale - Total (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
27.6
(10.3)
|
25.7
(10.4)
|
26.8
(10.3)
|
| Concise Health Risk Tracking (CHRT) - Propensity (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
22.8
(8.3)
|
21.4
(8.8)
|
22.1
(8.5)
|
| Concise Health Risk Tracking (CHRT) - Suicidal Thoughts (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
4.8
(2.6)
|
4.3
(2.4)
|
4.5
(2.5)
|
| Work & Social Adjustment Scale (WSAS) Total (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
24.0
(8.1)
|
22.6
(9.6)
|
22.8
(8.9)
|
| WHO-QOL-BREF Item 1 Quality of Life (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
3.1
(0.9)
|
3.3
(1.0)
|
3.2
(1.0)
|
| WHO-QOL-BREF Item 2 Satisfaction with Health (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
2.7
(1.0)
|
2.8
(1.2)
|
2.8
(1.1)
|
Outcome Measures
| Title | Change in Clinician Administered PTSD Scale (CAPS-5) |
|---|---|
| Description | Structured interview for assessment of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome. |
| Time Frame | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some Veterans skipped completing assessments |
| Arm/Group Title | IPT-PTSD | Prolonged Exposure | Difference Mean |
|---|---|---|---|
| Arm/Group Description | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination. | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). | Difference between mean of IPT-PTSD and Prolonged Exposure |
| Measure Participants | 58 | 51 | 109 |
| Baseline |
36.3
(7.2)
|
34.8
(7.4)
|
1.52
(1.4)
|
| End of Treatment |
27.8
(9.8)
|
28.2
(13.4)
|
-0.43
(2.57)
|
| Change |
-8.1
(9.0)
|
-5.5
(11.3)
|
-2.56
(2.25)
|
| 3 Month Post Treatment |
27.6
(12.4)
|
26.3
(14.7)
|
1.30
(3.16)
|
| 6 Month Post Treatment |
25.6
(12.5)
|
26.3
(14.3)
|
-0.61
(3.05)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Baseline | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.28 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Equivalence | |
| Comments | Confidence interval 95%, equivalence margin [-7,7]. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.52 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.4 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | End of Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.87 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Equivalence | |
| Comments | Confidence interval 95%, equivalence margin [-7,7]. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.43 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.57 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Change | |
| Type of Statistical Test | Equivalence | |
| Comments | Equivalence hypothesis was assessed using the confidence intervals for the mean differences compared to margins of equivalence (-7,7). The equivalence hypothesis was examined based on the difference between the amount of change from the baseline to the end of treatment on the CAPS between the two conditions. Confidence interval is -7.0 to 1.9. | |
| Statistical Test of Hypothesis | p-Value | 0.26 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Equivalence | |
| Comments | Confidence interval 95%, equivalence margin [-7,7]. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -2.56 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.25 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 3 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.68 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Equivalence | |
| Comments | Confidence interval 95%, equivalence margin [-7,7]. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.30 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.16 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 6 Month Follow Up | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.84 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Equivalence | |
| Comments | Confidence interval 95%, equivalence margin [-7,7]. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.61 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.05 |
|
| Estimation Comments | ||
| Title | Change in Inventory of Interpersonal Functioning (IIP-32) |
|---|---|
| Description | Self-report measure of Veterans' interpersonal difficulties. Scores range from a minimum value of 0 to a maximum value of 128, higher scores mean a worse outcome. |
| Time Frame | Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some Veterans skipped completing assessments |
| Arm/Group Title | IPT-PTSD | Prolonged Exposure | Difference Mean |
|---|---|---|---|
| Arm/Group Description | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination. | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). | Difference between mean of IPT-PTSD and Prolonged Exposure |
| Measure Participants | 58 | 51 | 109 |
| Baseline |
1.53
(0.64)
|
1.43
(0.56)
|
0.11
(0.12)
|
| 4 Week |
1.5
(0.5)
|
1.4
(0.7)
|
0.13
(0.14)
|
| 8 Week |
1.3
(0.5)
|
1.4
(0.7)
|
-0.12
(0.15)
|
| End of Treatment |
1.33
(0.63)
|
1.21
(0.66)
|
0.12
(0.14)
|
| Change |
-0.22
(0.57)
|
-0.15
(0.63)
|
-0.06
(0.13)
|
| 3 Month Post Treatment |
1.2
(0.60)
|
1.1
(0.60)
|
0.17
(0.14)
|
| 6 Month Post Treatment |
1.4
(0.60)
|
1.1
(0.60)
|
0.24
(0.14)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Baseline | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.36 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | One sided 97.5% confidence interval, superiority margin was 0.5 | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 4-Week | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.34 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | One sided 97.5% confidence interval, superiority margin was 0.5 | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 8-Week | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.43 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | One sided 97.5% confidence interval, superiority margin was 0.5 | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 6 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.09 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | One sided 97.5% confidence interval, superiority margin was 0.5 | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | End of Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.41 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | One sided 97.5% confidence interval, superiority margin was 0.5 | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Change | |
| Type of Statistical Test | Superiority | |
| Comments | Superiority hypotheses were assessed using the confidence interval for the mean differences (-0.33 to 0.20) compared to margin of superiority (-.05). | |
| Statistical Test of Hypothesis | p-Value | 0.64 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | One sided 97.5% confidence interval, superiority margin was 0.5 | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 3 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.22 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | One sided 97.5% confidence interval, superiority margin was 0.5 | |
| Title | Change in PTSD Checklist for DSM-5 Military Version (PCL-M) |
|---|---|
| Description | Self report measure of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome. |
| Time Frame | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some participants skipped assessments |
| Arm/Group Title | IPT-PTSD | Prolonged Exposure | Difference Between Means |
|---|---|---|---|
| Arm/Group Description | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunction. | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). | Difference between mean of IPT-PTSD and Prolonged Exposure |
| Measure Participants | 57 | 49 | 106 |
| Baseline |
48.0
(13.1)
|
45.8
(12.7)
|
2.15
(2.52)
|
| End of Treatment |
33.7
(15.9)
|
35.5
(19.8)
|
-1.82
(3.96)
|
| Change |
-12.8
(14.0)
|
-11.0
(18.8)
|
-1.75
(3.69)
|
| 3-Month Follow Up |
38.4
(17.4)
|
36.2
(21.2)
|
2.12
(4.46)
|
| 6-Month Follow Up |
36.1
(17.9)
|
37.4
(20.0)
|
-1.35
(4.38)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Baseline | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.40 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | End of Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.65 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Change | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.64 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 3 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.64 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 6 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.76 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Change in Patient Health Questionnaire (PHQ) |
|---|---|
| Description | Self report measure of mood and anxiety symptoms. Scores range from a minimum value of 0 to a maximum value of 27, higher scores mean a worse outcome. |
| Time Frame | Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some Veterans skipped completing assessments |
| Arm/Group Title | IPT-PTSD | Prolonged Exposure | Difference Mean |
|---|---|---|---|
| Arm/Group Description | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination. | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). | Difference between mean of IPT-PTSD and Prolonged Exposure |
| Measure Participants | 58 | 51 | 109 |
| Baseline |
15.2
(6.4)
|
13.0
(7.3)
|
2.15
(1.32)
|
| Week 4 |
13.9
(5.3)
|
12.9
(7.2)
|
1.0
(1.39)
|
| Week 8 |
11.1
(5.2)
|
11.6
(6.9)
|
-0.50
(1.52)
|
| End of Treatment |
11.8
(6.5)
|
10.3
(7.1)
|
1.47
(1.51)
|
| Change |
-3.1
(7.5)
|
-2.4
(7.0)
|
-0.74
(1.63)
|
| 3 Month |
12.6
(5.7)
|
10.3
(7.3)
|
2.25
(1.51)
|
| 6 Month |
13.2
(6.1)
|
11.1
(7.2)
|
2.09
(1.54)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Baseline | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.11 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 4-Week | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.48 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 8-Week | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.74 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | End of Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.34 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Change | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.65 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 3 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.14 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 6 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.18 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other |
|---|---|
| Description | Self-report measure of a participant's subjective social support with regards to a participant's significant other. For each subscale, the mean of items is reported therefore for the Significant Other Subscale: Sum across items 1, 2, 5, & 10, then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome. |
| Time Frame | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some Veterans skipped completing assessments |
| Arm/Group Title | IPT-PTSD | Prolonged Exposure | Difference Mean |
|---|---|---|---|
| Arm/Group Description | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination. | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). | Difference between mean of IPT-PTSD and Prolonged Exposure |
| Measure Participants | 58 | 51 | 109 |
| Baseline |
4.9
(1.9)
|
5.5
(1.2)
|
-0.56
(0.31)
|
| End of Treatment |
4.9
(2.0)
|
5.7
(1.5)
|
-0.74
(0.40)
|
| Change |
-0.13
(1.33)
|
-0.18
(0.99)
|
0.05
(0.27)
|
| 3 Month Post Tx |
4.9
(1.7)
|
6.0
(1.4)
|
-1.10
(0.36)
|
| 6 Month Post Tx |
5.2
(1.6)
|
6.0
(1.3)
|
-0.76
(0.34)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Baseline | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.08 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | End of Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.07 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Change | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.86 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 3 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 6 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.03 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family |
|---|---|
| Description | Self-report measure of a participant's subjective social support with regards to a participant's family. For each subscale, the mean of items is reported therefore for the Family Subscale: Sum across items 3, 4, 8, & 11 then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome. |
| Time Frame | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some Veterans skipped completing assessments |
| Arm/Group Title | IPT-PTSD | Prolonged Exposure | Difference Mean |
|---|---|---|---|
| Arm/Group Description | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination. | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). | Difference between mean of IPT-PTSD and Prolonged Exposure |
| Measure Participants | 58 | 51 | 109 |
| Baseline |
3.9
(1.8)
|
4.6
(1.7)
|
-0.66
(0.33)
|
| End of Treatment |
4.4
(1.6)
|
5.1
(1.7)
|
-0.75
(0.36)
|
| Change |
0.34
(1.54)
|
0.27
(1.76)
|
0.07
(0.36)
|
| 3 Month Post Tx |
4.0
(1.7)
|
5.5
(1.2)
|
-1.48
(0.34)
|
| 6 Month Post Tx |
4.5
(1.7)
|
5.0
(1.8)
|
-0.56
(0.40)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Baseline | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.05 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | End of Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.04 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Change | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.86 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 3 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 6 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.16 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends |
|---|---|
| Description | Self-report measure of a participant's subjective social support with regards to a participant's family. For each subscale, the mean of items is reported therefore for the Friends Subscale: Sum across items 6, 7, 9, & 12 then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome. |
| Time Frame | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some Veterans skipped completing assessments |
| Arm/Group Title | IPT-PTSD | Prolonged Exposure | Difference Mean |
|---|---|---|---|
| Arm/Group Description | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination. | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). | Difference between mean of IPT-PTSD and Prolonged Exposure |
| Measure Participants | 58 | 51 | 109 |
| Baseline |
3.9
(1.6)
|
4.1
(1.5)
|
-0.23
(0.30)
|
| End of Treatment |
4.4
(1.7)
|
4.3
(1.8)
|
0.14
(0.38)
|
| Change |
0.5
(1.6)
|
0.3
(1.8)
|
0.20
(0.39)
|
| 3 Month Post Tx |
3.9
(1.5)
|
4.4
(1.7)
|
-0.57
(0.37)
|
| 6 Month Post Tx |
4.3
(1.6)
|
4.2
(1.8)
|
0.10
(0.38)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Baseline | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.45 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | End of Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.71 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Change | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.60 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 3 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.13 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 6 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.80 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Change in Concise Health Risk Tracking Scale - Total (CHRT) |
|---|---|
| Description | Self report measure of suicidal ideation and related symptoms. Our study used a response scale of 1 to 5. The CHRT has 12 items, and the total score has a possible range of 12 to 60. Higher scores indicate more suicidal ideation and risk. |
| Time Frame | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some Veterans skipped assessments |
| Arm/Group Title | IPT-PTSD | Prolonged Exposure | Difference Between Means |
|---|---|---|---|
| Arm/Group Description | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunction. | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). | Difference between mean of IPT-PTSD and Prolonged Exposure |
| Measure Participants | 58 | 51 | 109 |
| Baseline |
27.6
(10.3)
|
25.7
(10.4)
|
1.87
(1.98)
|
| End of Treatment |
25.4
(8.9)
|
21.9
(10.9)
|
3.49
(2.13)
|
| Change |
-2.7
(8.9)
|
-3.5
(11.3)
|
0.72
(2.16)
|
| 3-Month Follow Up |
27.1
(9.9)
|
22.1
(9.8)
|
5.04
(2.28)
|
| 6-Month Follow Up |
26.3
(9.7)
|
23.5
(10.3)
|
2.8
(2.27)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Baseline | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.35 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | End of Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.11 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Change | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.74 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 3 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.03 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 6 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.22 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Change in Concise Health Risk Tracking Scale (CHRT) - Propensity |
|---|---|
| Description | The propensity subscale score includes 9 items assessing, hopelessness, self-worth and perceived social support, and the possible range for our study is 9 to 45 Higher scores indicate worse outcome. |
| Time Frame | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some Veterans skipped assessments |
| Arm/Group Title | IPT-PTSD | Prolonged Exposure | Difference Between Means |
|---|---|---|---|
| Arm/Group Description | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunction. | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). | Difference between mean of IPT-PTSD and Prolonged Exposure |
| Measure Participants | 58 | 51 | 109 |
| Baseline |
22.8
(8.3)
|
21.4
(8.8)
|
1.40
(1.63)
|
| End of Treatment |
20.6
(7.6)
|
17.9
(9.4)
|
2.68
(1.82)
|
| Change |
-2.6
(7.3)
|
-3.2
(9.3)
|
0.64
(1.78)
|
| 3-Month Follow Up |
21.9
(7.9)
|
18.0
(8.6)
|
3.91
(1.89)
|
| 6-Month Follow Up |
21.4
(7.7)
|
18.9
(8.8)
|
2.46
(1.87)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Baseline | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.39 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | End of Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.15 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Change | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.72 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 3 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.04 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 6 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.19 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts |
|---|---|
| Description | The CHRT Suicidal Thoughts subscale includes 3 items and has a possible range in our study from 3 to 15. Higher scores indicate higher suicidal thoughts. |
| Time Frame | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some Veterans missed assessments |
| Arm/Group Title | IPT-PTSD | Prolonged Exposure | Difference Between Means |
|---|---|---|---|
| Arm/Group Description | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunction. | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). | Difference between mean of IPT-PTSD and Prolonged Exposure |
| Measure Participants | 58 | 51 | 109 |
| Baseline |
4.8
(2.6)
|
4.3
(2.4)
|
0.47
(0.48)
|
| End of Treatment |
4.8
(2.4)
|
4.0
(2.3)
|
0.81
(0.50)
|
| Change |
-0.16
(2.33)
|
-0.24
(2.83)
|
0.08
(0.55)
|
| 3-Month Follow Up |
5.2
(2.9)
|
4.1
(2.0)
|
1.13
(0.57)
|
| 6-Month Follow Up |
4.9
(2.5)
|
4.6
(2.5)
|
0.33
(0.57)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Baseline | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.33 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | End of Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.11 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Change | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.88 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 3 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.06 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 6 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.56 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Change in Work and Social Adjustment Scale (WSAS) |
|---|---|
| Description | Self report measure of functional impairment in five areas of functioning (work, home management, social leisure, personal leisure, close relationships. Scores range from a minimum value of 0 to a maximum value of 40, higher scores mean a worse outcome. |
| Time Frame | Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some Veterans missed completing assessments |
| Arm/Group Title | IPT-PTSD | Prolonged Exposure | Difference Mean |
|---|---|---|---|
| Arm/Group Description | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination. | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). | Difference between mean of IPT-PTSD and Prolonged Exposure |
| Measure Participants | 58 | 51 | 109 |
| Baseline |
24.0
(8.1)
|
22.6
(9.6)
|
2.40
(1.70)
|
| End of Treatment |
20.4
(10.8)
|
15.8
(11.6)
|
4.58
(2.41)
|
| Change |
-3.5
(9.7)
|
-5.1
(9.9)
|
1.58
(2.12)
|
| 3 Month Post Tx |
23.4
(9.2)
|
15.5
(11.5)
|
7.96
(2.37)
|
| 6 Month Post Tx |
23.4
(9.3)
|
15.7
(11.6)
|
7.73
(2.37)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Baseline | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.16 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | End of Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.06 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Change | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.46 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 3 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 6 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life |
|---|---|
| Description | Measure of four domains related to quality of life: physical health, psychological, social relationships and environment. Data presented from Item 1 (Quality of Life) Scores range from a minimum value of 1 to a maximum value of 5, lower scores mean a worse outcome. |
| Time Frame | Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some Veterans missed completing assessments |
| Arm/Group Title | IPT-PTSD | Prolonged Exposure | Difference Between Means |
|---|---|---|---|
| Arm/Group Description | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunction. | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). | Difference between mean of IPT-PTSD and Prolonged Exposure |
| Measure Participants | 58 | 51 | 109 |
| Baseline |
3.1
(0.9)
|
3.3
(1.0)
|
-0.21
(0.18)
|
| End of Treatment |
3.2
(0.9)
|
3.2
(1.0)
|
0.05
(0.20)
|
| Change |
0.04
(0.91)
|
-0.21
(0.98)
|
0.25
(0.21)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Baseline | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.24 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | End of Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.81 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Change | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.24 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health |
|---|---|
| Description | Measure of four domains related to quality of life: physical health, psychological, social relationships and environment. Data presented from Item 2 (Satisfaction with Health). Scores range from a minimum value of 1 to a maximum value of 5, lower scores mean a worse outcome. |
| Time Frame | Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some Veterans skipped completing assessments |
| Arm/Group Title | IPT-PTSD | Prolonged Exposure | Difference Between Means |
|---|---|---|---|
| Arm/Group Description | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunction. | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). | Difference between mean of IPT-PTSD and Prolonged Exposure |
| Measure Participants | 58 | 51 | 109 |
| Baseline |
2.7
(1.0)
|
2.8
(1.2)
|
-0.17
(0.21)
|
| End of Treatment |
2.6
(1.0)
|
2.9
(1.1)
|
-0.29
(0.23)
|
| Change |
-0.12
(1.18)
|
0.06
(1.23)
|
-0.18
(0.27)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Baseline | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.41 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | End of Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.21 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Change | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.50 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | GAD - 7 Generalized Anxiety Disorder |
|---|---|
| Description | Measure of generalized anxiety amongst participants over time. Scores range from a minimum value of 0 to a maximum value of 21, higher scores mean a worse outcome. |
| Time Frame | Baseline to 6 months posttreatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some Veterans skipped completing assessments |
| Arm/Group Title | IPT-PTSD | Prolonged Exposure | Difference Between Means |
|---|---|---|---|
| Arm/Group Description | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunction. | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). | Difference between mean of IPT-PTSD and Prolonged Exposure |
| Measure Participants | 58 | 51 | 109 |
| Baseline |
12.1
(5.8)
|
11.6
(6.2)
|
0.44
(1.15)
|
| Week 4 |
12.2
(4.9)
|
12.1
(5.5)
|
0.06
(1.17)
|
| Week 8 |
9.6
(5.5)
|
10.5
(6.4)
|
-0.84
(1.53)
|
| End of Treatment |
9.7
(5.7)
|
9.0
(5.8)
|
0.65
(1.29)
|
| Change |
-2.3
(5.1)
|
-2.6
(6.3)
|
0.25
(1.25)
|
| 3 Month Follow Up |
11.1
(6.0)
|
9.6
(6.0)
|
1.49
(1.43)
|
| 6 Month Follow Up |
11.0
(5.3)
|
9.2
(5.6)
|
1.80
(1.27)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Baseline | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.70 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Week 4 | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Week 8 | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.59 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | End of Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.61 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | Change | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.84 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 3 Month Follow Up | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.30 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | IPT-PTSD, Prolonged Exposure |
|---|---|---|
| Comments | 6 Month Post Treatment | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.16 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Adverse Events
| Time Frame | Baseline to 6 months post-treatment, an average of 9 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Definitions do not differ. | |||
| Arm/Group Title | IPT-PTSD | Prolonged Exposure | ||
| Arm/Group Description | Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination. | Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities). | ||
All Cause Mortality |
||||
| IPT-PTSD | Prolonged Exposure | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/61 (0%) | 0/54 (0%) | ||
Serious Adverse Events |
||||
| IPT-PTSD | Prolonged Exposure | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/61 (13.1%) | 3/54 (5.6%) | ||
| Injury, poisoning and procedural complications | ||||
| Domestic Violence issue - Sustained minor injury | 2/61 (3.3%) | 2 | 0/54 (0%) | 0 |
| Psychiatric disorders | ||||
| Inpatient Hospitalization - Alcohol | 3/61 (4.9%) | 3 | 2/54 (3.7%) | 2 |
| Inpatient Hospitalization-Depression/Suicidal Ideation | 2/61 (3.3%) | 2 | 0/54 (0%) | 0 |
| Inpatient Hospitalization - Drugs | 0/61 (0%) | 0 | 1/54 (1.9%) | 1 |
| Inpatient Hospitalization-Schizoaffective Disorder | 1/61 (1.6%) | 1 | 0/54 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| IPT-PTSD | Prolonged Exposure | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/61 (0%) | 0/54 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Tracie Shea |
|---|---|
| Organization | Providence VA Medical Center |
| Phone | 401-273-7100 ext 6248 |
| MaryTracie.Shea@va.gov |
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02586064
Other Study ID Numbers:
- D1783-R
- I01RX001783
First Posted:
Oct 26, 2015
Last Update Posted:
Jul 7, 2021
Last Verified:
Jun 1, 2021