Clincosm LogoSign in Get a demo

Prolonged Exposure (PE) for Post Traumatic Stress Disorder (PTSD): Telemedicine Versus In Person

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01102764
Collaborator
University of Pennsylvania (Other), University of Hawaii (Other)
150
Enrollment
1
Location
2
Arms
59
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The present proposal is to study whether Prolonged Exposure (PE) delivered via Telemedicine is as effective as PE delivered In Person for Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF) Veterans and Veterans of all theatres, particularly Vietnam era with Post-Traumatic Stress Disorder (PTSD). ).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Telemedicine
  • Behavioral: In Person
 N/A

Detailed Description

Project Background/Rationale: Approximately 15 to 17% of current Iraq war Veterans meet full diagnostic criteria for MH problems such as post-traumatic stress disorder (PTSD) (Hoge et al., 2004). Prolonged Exposure (PE) is an empirically supported treatment for PTSD (Foa 1997; Schnurr et al., 2007), and has been adopted by the Department of Veterans Affairs (DOVA) as one of the treatments of choice for the disorder, as evident by the DOVA-sponsored national training of clinicians to use PE. It is therefore important to employ treatment delivery methods that maximize the likelihood that all Veterans in need, including Veterans residing in rural settings, and Veterans who avoid DOVA settings due to the stigma of receiving mental health treatment, will receive interventions such as PE. The May, 2005 Committee on Veterans Affairs, Subcommittee on Health has identified Telemedicine as a DOVA priority area to address this need. The present proposal is to study whether PE delivered via Telemedicine is as effective as PE delivered In Person. Telemedicine has been chosen for its ability to overcome what appear to be two major barriers to mental health care (Frueh et al., 2000): the difficulty that rural-residing Veterans face in reaching VAMC facilities, and the stigma Veterans perceive related to receiving mental health treatment. Indeed, if effective, PE delivered via telemedicine may address the problem inherent in the finding that 42% of those screening positive for PTSD indicate that they are interested in receiving help, but only 25% actually receive services (Hoge, et al., 2006).

Project Objectives: Although effective treatments for PTSD exist and have been adopted by the Veterans Affairs Medical Centers (VAMC), barriers to care of a social (e.g., stigma) and geographic (e.g., rural) nature prevent many Veterans in need from receiving care. Telemedicine might address this need. The major objective of this study is to determine if PE delivered via Telemedicine is as effective as In Person PE in terms of (1) clinical; (2) process; and (3) economic outcomes.

Project Methods: The investigators propose to use a randomized between groups repeated measures (baseline, post-treatment, 3& 6-month followups) design with 226 OIF-OEF Veterans diagnosed with PTSD to assess the relative effectiveness, measured in terms of symptoms, patient satisfaction, and costs, of PE delivered via Telemedicine vs. In Person formats. The investigators hypothesize that no differences (i.e., non-inferiority) between the two formats will be evident in terms treatment gains, patient satisfaction, treatment attrition, patient satisfaction and direct health care costs.

Anticipated Impacts on Veterans Health care: This study will provide important information regarding whether PE delivered via home-based Telemedicine equipment is as effective as traditional In Person delivery of PE for post-traumatic stress disorder. If shown to be as effective as In Person treatment, a new, innovative, and cost effective intervention delivery system for PTSD will have initial empirical support.

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Prolonged Exposure (PE) for PTSD: Telemedicine vs. In Person
Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1: PE via telemedicine

PE via telemedicine

Behavioral: Telemedicine
Prolonged Exposure (PE) therapy provided at patients house via telemedicine
Active Comparator: Arm 2: PE in person

PE in person

Behavioral: In Person
PE therapy delivered in person at the VAMC

Outcome Measures

Primary Outcome Measures

  1. Treatment Completion [13 weeks]

    The major objective of this study is to determine if PE delivered via Telemedicine is as effective as In Person PE in terms of (1) clinical (PTSD and Depression); (2) process (Treatment Satisfaction and Attrition); and (3) economic (Cost) outcomes. Per protocol, participants could have as many as 12 treatment sessions. Per protocol treatment completers completed at least 6 90-minute sessions of Prolonged Exposure either In Person or via Telemedicine. Treatment dropout is defined as initiating treatment but completing fewer than 6 sessions.

  2. PTSD Checklist-Military (PCL-M) [26 weeks]

    PTSD Checklist-Military (PCL-M): The PCL is a 17 Item Self Report Measure of PTSD Symptoms Based on the DSM-IV Criteria. The PCL uses a 5-point Likert scale response format ranging from not at all to frequently. The instrument is highly correlated with the Clinician Administered PTSD Scale (r = .93), has good diagnostic efficiency (> .70), and robust psychometrics with a variety of trauma populations (Blanchard, 1996), including combat veterans (Magruder, Frueh, et al, 2005). Total scores on the PCL range from 17 to 85, with lower scores indicating less symptom severity.

  3. Beck Depression Inventory-II (BDI-II) [26 weeks]

    Beck Depression Inventory-II (BDI-II): (BDI; Beck et al., 1961): The BDI-II is a 21-item self-report scale, is among the most widely used instruments to measure depression. Beck and Steer (1984) demonstrated that the BDI-I has high internal consistency (α = .86 - .91). Lower scores indicate less symptom severity, and higher scores indicate more severe depressive symptoms. Raw scores of 0-13 indicates minimal depression; 14-19 indicates mild depression; 20-28 indicates moderate depression; 29-63 indicates severe depression. The lowest possible score on this measure is 0, and the highest possible score is 63.

Secondary Outcome Measures

  1. Clinician Administered PTSD Scale for DSM-IV (CAPS IV) [26 weeks]

    The Clinician Administered PTSD Scale (CAPS) is a structured interview designed to make a categorical PTSD diagnosis, as well as to provide a measure of PTSD symptom severity. The structure corresponds to the DSM-IV criteria for PTSD diagnoses, with B, C, and D symptoms rated for both frequency and intensity; these two scores (frequency + intensity) are summed to provide severity ratings. Additional questions assess Criteria A, E, and F. It is recommended that the "1, 2" rule be used to determine whether a symptom meets criteria; that is, a frequency score of at least 1 (scale 0 = "none of the time" to 4 = "most or all of the time") and an intensity score of at least 2 (scale 0 = "none" to 4 = "extreme") is required for a particular symptom to meet criteria. Total scores from B, C and D range from 0 to 136, with lower scores indicating better outcomes, and higher scores indicating worse outcomes.

  2. Deployment Risk and Resiliency Inventory (DRRI) [Week 0]

    The DRRI is collection of self-report measures assessing 14 key deployment-related risk and resilience factors with demonstrated implications for veterans' long-term health. With the nature of military deployment changing, with a larger proportion of women, National Guard and Reserves being deployed for more contemporary conflicts, the DRRI was developed to provide a more comprehensive assessment of the current combat-related experiences. The DRRI is made up of multiple scales to represent different constructs. Responses are either dichotomous (0=No, 1=Yes), polytomous (0=No, 1=Not Sure, 2=Yes), or recorded on a 4, 5 or 6 point Likert scales. Scores for each section are summed are contain scoring ranges. Higher scores are indicative of worse outcomes.

  3. Health Related Functioning: Medical Outcome Study (MOS) Short Study Forms-36 Health Survey (SF 36) [26 weeks]

    The MOS SF-36 is an indicator of overall health status. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each of the eight summed scores is linearly transformed onto a scale from 0 (negative health) to 100 (positive health) to provide a score for each subscale. Therefore, lower scores indicate more disability while higher scores indicate less disability. Each subscale can be used independently. Sections of the SF-36 include: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health.

  4. Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA) [14 weeks]

    The CPOSS is a 16-item measure, with a Likert scale response format, based on a general measure of patient satisfaction. Extant data demonstrate that the measure has excellent reliability (alpha = 0.96) and good convergent validity with relevant anchor items ("would you recommend this treatment to a friend or family member?"). Items are scored using a 5 point Likert scale (5=excellent; 4=very good; 3=good; 2=fair; 1=poor). The scale is scored by summing the scores of all individual items. The possible range is 16 to 80, with higher scores indicating higher satisfaction.

  5. Treatment Credibility [4 weeks]

    This measures assesses for differences in outcome expectancy. The Treatment Credibility Scale (as used in this study) contains 4 questions. Each question is scored individually via 10-point Likert scales. Questions asses how logical treatment seems, how confident participants are about treatment, and expectations of success and is administered at treatment session 4. Scores on treatment logicality, confidence and predicted success on each question range from 1 (not at all) to 10 (very logical), with mid-range scores indicating moderate logicality, confidence and predicted success.

  6. Service Delivery Perceptions Questionnaire [26 weeks]

    This measure is used to assess Veterans' perceptions about variables specifically related to this mode of service delivery (e.g., the quality of communication, ease of use, and willingness to use treatment via videoconferencing in the future). There are 8 questions (1 question was not assessed due to asking about group participation which is irrelevant to the current study). All questions are answered via a 5 point Likert scale, with 1 indicating poor perceptions and 5 indicating excellent perceptions. Scores range from 7-35, with higher scores indicating more positive outcomes.

  7. Structured Clinical Interview for DSM-IV (SCID-I) [26 weeks]

    The Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) is a semistructured interview to determine whether an individual meets criteria for any Axis I disorder in the Diagnostic and Statistical Manual of Mental Disorders (version IV). The SCID is broken down into separate modules corresponding to categories of diagnoses, and uses skip logic to allow the interviewer to skip questions or modules if certain diagnostic criteria are indicated. Most sections begin with an entry question that would allow the interviewer to "skip" the associated questions if not met. For all diagnoses symptoms are coded as present, subthreshold, or absent. It assesses for both current and lifetime diagnoses and prompts the interviewer to document age of illness onset and to rate current illness severity (Glasofer et al., 2015).

  8. Prior Experience With Computer and Audiovisual Technology [Week 0]

    The Prior Experience With Technology questionnaire is an 8-item short measure to learn more about participants' prior experiences and comfort level with computers and audiovisual technology. For 8 different technological devices, the measure asks if the participant has the device in his/her home (i.e. Is there a telephone in your home)? Subsequent questions determine whether the patient is comfortable using that device or, if he/she does not own one, if he/she would be willing to learn to use one. Devices assessed include telephone, television, stereo, video player (e.g. VCR, DVD), computer, internet, e-mail, and audiovisual conferencing technology. These data may help identify whether these variables are associated with clinical outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Participants will be 226 male and female:

  • Operation Iraqi Freedom, Operation Enduring Freedom (OIF OEF) Veterans, and Veterans of all theatres, particularly Vietnam era Veterans.

  • age 21 and above, and

  • diagnosed via structured clinical interview with PTSD

Exclusion Criteria:

  • Actively psychotic or demented persons,

  • individuals with both suicidal ideation and clear intent, and

  • individuals meeting full criteria for substance dependence will be excluded from participation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ralph H. Johnson VA Medical Center, Charleston, SC Charleston South Carolina United States 29401-5799

Sponsors and Collaborators

  • VA Office of Research and Development
  • University of Pennsylvania
  • University of Hawaii

Investigators

  • Principal Investigator: Ron E. Acierno, PhD MS BA, Ralph H. Johnson VA Medical Center, Charleston, SC

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01102764
Other Study ID Numbers:
  • IAC 09-040
  • 19695
First Posted:
Apr 13, 2010
Last Update Posted:
Mar 4, 2019
Last Verified:
Nov 1, 2018
Keywords provided by VA Office of Research and Development
Anxiety Disorders: PTSD
Prolong Exposure (PE)
Telemedicine
cost effectiveness
deployment related problems
mental health care delivery
Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Recruitment Details The research team mailed invitation to participate brochures to a VAMC roster of Veterans of all theatres. IRB-approved recruitment flyers were placed throughout the main hospital and surrounding VA clinics. Furthermore, the team accepted direct referrals from VA providers and the Post Traumatic Stress Disorder Clinical Team (PCT).
Pre-assignment Detail There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who were analyzed because they completed at least 1 treatment session.
Arm/Group Title Arm 1: PE Via Telemedicine Arm 2: PE in Person
Arm/Group Description PE via telemedicine Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine PE in person In Person: PE therapy delivered in person at the VAMC
Period Title: Overall Study
STARTED 64 68
COMPLETED 43 55
NOT COMPLETED 21 13

Baseline Characteristics

Arm/Group Title Arm 1: PE Via Telemedicine Arm 2: PE in Person Total
Arm/Group Description PE via telemedicine Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine PE in person In Person: PE therapy delivered in person at the VAMC Total of all reporting groups
Overall Participants 64 68 132
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
40.7
(14.9)
42.9
(14.1)
41.8
(14.5)
Sex: Female, Male (Count of Participants)
Female
1
1.6%
4
5.9%
5
3.8%
Male
63
98.4%
64
94.1%
127
96.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
21
32.8%
23
33.8%
44
33.3%
White
39
60.9%
41
60.3%
80
60.6%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
4
6.3%
4
5.9%
8
6.1%
Region of Enrollment (Count of Participants)
United States
64
100%
68
100%
132
100%
Mean Service Connection Rating (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
55.8
(35.7)
51.4
(40.2)
53.5
(37.9)
Marital Status (participants) [Number]
Never Married
15
23.4%
15
22.1%
30
22.7%
Married
36
56.3%
37
54.4%
73
55.3%
Separated/Divorced
11
17.2%
12
17.6%
23
17.4%
Widowed
1
1.6%
2
2.9%
3
2.3%
Unknown
1
1.6%
2
2.9%
3
2.3%

Outcome Measures

1. Primary Outcome
Title Treatment Completion
Description The major objective of this study is to determine if PE delivered via Telemedicine is as effective as In Person PE in terms of (1) clinical (PTSD and Depression); (2) process (Treatment Satisfaction and Attrition); and (3) economic (Cost) outcomes. Per protocol, participants could have as many as 12 treatment sessions. Per protocol treatment completers completed at least 6 90-minute sessions of Prolonged Exposure either In Person or via Telemedicine. Treatment dropout is defined as initiating treatment but completing fewer than 6 sessions.
Time Frame 13 weeks

Outcome Measure Data

Analysis Population Description
There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.
Arm/Group Title Arm 1: PE Via Telemedicine Arm 2: PE in Person
Arm/Group Description PE via telemedicine Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine PE in person In Person: PE therapy delivered in person at the VAMC
Measure Participants 64 68
Overall Average Number of Sessions Completed
7.6
8.6
Average Number of Sessions Prior to Dropout
3.1
2.9
2. Primary Outcome
Title PTSD Checklist-Military (PCL-M)
Description PTSD Checklist-Military (PCL-M): The PCL is a 17 Item Self Report Measure of PTSD Symptoms Based on the DSM-IV Criteria. The PCL uses a 5-point Likert scale response format ranging from not at all to frequently. The instrument is highly correlated with the Clinician Administered PTSD Scale (r = .93), has good diagnostic efficiency (> .70), and robust psychometrics with a variety of trauma populations (Blanchard, 1996), including combat veterans (Magruder, Frueh, et al, 2005). Total scores on the PCL range from 17 to 85, with lower scores indicating less symptom severity.
Time Frame 26 weeks

Outcome Measure Data

Analysis Population Description
There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.
Arm/Group Title Arm 1: PE Via Telemedicine Arm 2: PE in Person
Arm/Group Description PE via telemedicine Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine PE in person In Person: PE therapy delivered in person at the VAMC
Measure Participants 64 68
Average PCL Score at Baseline
64
61.8
Average PCL Score at 1 week Post Tx
48.4
44.9
Average PCL Score at 3 months Post Tx
49.2
46.5
Average PCL Score at 6 months Post Tx
51.7
48.0
3. Primary Outcome
Title Beck Depression Inventory-II (BDI-II)
Description Beck Depression Inventory-II (BDI-II): (BDI; Beck et al., 1961): The BDI-II is a 21-item self-report scale, is among the most widely used instruments to measure depression. Beck and Steer (1984) demonstrated that the BDI-I has high internal consistency (α = .86 - .91). Lower scores indicate less symptom severity, and higher scores indicate more severe depressive symptoms. Raw scores of 0-13 indicates minimal depression; 14-19 indicates mild depression; 20-28 indicates moderate depression; 29-63 indicates severe depression. The lowest possible score on this measure is 0, and the highest possible score is 63.
Time Frame 26 weeks

Outcome Measure Data

Analysis Population Description
There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.
Arm/Group Title Arm 1: PE Via Telemedicine Arm 2: PE in Person
Arm/Group Description PE via telemedicine Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine PE in person In Person: PE therapy delivered in person at the VAMC
Measure Participants 64 68
Average BDI Score at Baseline
28.0
27.4
Average BDI Score at 1 week Post Tx
21.7
19.6
Average BDI Score at 3 months Post Tx
18.3
17.6
Average BDI Score at 6 months Post Tx
21.6
18.4
4. Secondary Outcome
Title Clinician Administered PTSD Scale for DSM-IV (CAPS IV)
Description The Clinician Administered PTSD Scale (CAPS) is a structured interview designed to make a categorical PTSD diagnosis, as well as to provide a measure of PTSD symptom severity. The structure corresponds to the DSM-IV criteria for PTSD diagnoses, with B, C, and D symptoms rated for both frequency and intensity; these two scores (frequency + intensity) are summed to provide severity ratings. Additional questions assess Criteria A, E, and F. It is recommended that the "1, 2" rule be used to determine whether a symptom meets criteria; that is, a frequency score of at least 1 (scale 0 = "none of the time" to 4 = "most or all of the time") and an intensity score of at least 2 (scale 0 = "none" to 4 = "extreme") is required for a particular symptom to meet criteria. Total scores from B, C and D range from 0 to 136, with lower scores indicating better outcomes, and higher scores indicating worse outcomes.
Time Frame 26 weeks

Outcome Measure Data

Analysis Population Description
There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.
Arm/Group Title Arm 1: PE Via Telemedicine Arm 2: PE in Person
Arm/Group Description PE via telemedicine Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine PE in person In Person: PE therapy delivered in person at the VAMC
Measure Participants 64 68
Mean CAPS Score at Baseline
68.4
68.2
Mean CAPS Score at 1 Week Post
41.9
41.1
Mean CAPS Score at 3 Month Post
41.0
38.7
Mean CAPS Score at 6 Month Post
46.8
41.0
5. Secondary Outcome
Title Deployment Risk and Resiliency Inventory (DRRI)
Description The DRRI is collection of self-report measures assessing 14 key deployment-related risk and resilience factors with demonstrated implications for veterans' long-term health. With the nature of military deployment changing, with a larger proportion of women, National Guard and Reserves being deployed for more contemporary conflicts, the DRRI was developed to provide a more comprehensive assessment of the current combat-related experiences. The DRRI is made up of multiple scales to represent different constructs. Responses are either dichotomous (0=No, 1=Yes), polytomous (0=No, 1=Not Sure, 2=Yes), or recorded on a 4, 5 or 6 point Likert scales. Scores for each section are summed are contain scoring ranges. Higher scores are indicative of worse outcomes.
Time Frame Week 0

Outcome Measure Data

Analysis Population Description
The outcome data for this measure is not available because there was not enough sufficient responses to generate analyses.
Arm/Group Title Arm 1: PE Via Telemedicine Arm 2: PE in Person
Arm/Group Description PE via telemedicine Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine PE in person In Person: PE therapy delivered in person at the VAMC
Measure Participants 0 0
6. Secondary Outcome
Title Health Related Functioning: Medical Outcome Study (MOS) Short Study Forms-36 Health Survey (SF 36)
Description The MOS SF-36 is an indicator of overall health status. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each of the eight summed scores is linearly transformed onto a scale from 0 (negative health) to 100 (positive health) to provide a score for each subscale. Therefore, lower scores indicate more disability while higher scores indicate less disability. Each subscale can be used independently. Sections of the SF-36 include: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health.
Time Frame 26 weeks

Outcome Measure Data

Analysis Population Description
There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.
Arm/Group Title Arm 1: PE Via Telemedicine Arm 2: PE in Person
Arm/Group Description PE via telemedicine Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine PE in person In Person: PE therapy delivered in person at the VAMC
Measure Participants 64 68
% reported very good/excellent health at Baseline
18.60
29.1%
10.90
16%
% reported very good/excellent health: 1 week F/U
17.90
28%
19.00
27.9%
% reported very good/excellent health: 3 mo. F/U
15.00
23.4%
12.90
19%
% reported very good/excellent health: 6 mo. F/U
18.90
29.5%
22.00
32.4%
7. Secondary Outcome
Title Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA)
Description The CPOSS is a 16-item measure, with a Likert scale response format, based on a general measure of patient satisfaction. Extant data demonstrate that the measure has excellent reliability (alpha = 0.96) and good convergent validity with relevant anchor items ("would you recommend this treatment to a friend or family member?"). Items are scored using a 5 point Likert scale (5=excellent; 4=very good; 3=good; 2=fair; 1=poor). The scale is scored by summing the scores of all individual items. The possible range is 16 to 80, with higher scores indicating higher satisfaction.
Time Frame 14 weeks

Outcome Measure Data

Analysis Population Description
There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.
Arm/Group Title Arm 1: PE Via Telemedicine Arm 2: PE in Person
Arm/Group Description PE via telemedicine Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine PE in person In Person: PE therapy delivered in person at the VAMC
Measure Participants 64 68
Mean (Full Range) [score on a scale]
65.6
65.5
8. Secondary Outcome
Title Treatment Credibility
Description This measures assesses for differences in outcome expectancy. The Treatment Credibility Scale (as used in this study) contains 4 questions. Each question is scored individually via 10-point Likert scales. Questions asses how logical treatment seems, how confident participants are about treatment, and expectations of success and is administered at treatment session 4. Scores on treatment logicality, confidence and predicted success on each question range from 1 (not at all) to 10 (very logical), with mid-range scores indicating moderate logicality, confidence and predicted success.
Time Frame 4 weeks

Outcome Measure Data

Analysis Population Description
There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.
Arm/Group Title Arm 1: PE Via Telemedicine Arm 2: PE in Person
Arm/Group Description PE via telemedicine Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine PE in person In Person: PE therapy delivered in person at the VAMC
Measure Participants 64 68
Mean (Full Range) [scores on a scale]
4.4
4.5
9. Secondary Outcome
Title Service Delivery Perceptions Questionnaire
Description This measure is used to assess Veterans' perceptions about variables specifically related to this mode of service delivery (e.g., the quality of communication, ease of use, and willingness to use treatment via videoconferencing in the future). There are 8 questions (1 question was not assessed due to asking about group participation which is irrelevant to the current study). All questions are answered via a 5 point Likert scale, with 1 indicating poor perceptions and 5 indicating excellent perceptions. Scores range from 7-35, with higher scores indicating more positive outcomes.
Time Frame 26 weeks

Outcome Measure Data

Analysis Population Description
There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.
Arm/Group Title Arm 1: PE Via Telemedicine Arm 2: PE in Person
Arm/Group Description PE via telemedicine Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine PE in person In Person: PE therapy delivered in person at the VAMC
Measure Participants 64 68
Mean (Full Range) [units on a scale]
4.6
4.7
10. Secondary Outcome
Title Structured Clinical Interview for DSM-IV (SCID-I)
Description The Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) is a semistructured interview to determine whether an individual meets criteria for any Axis I disorder in the Diagnostic and Statistical Manual of Mental Disorders (version IV). The SCID is broken down into separate modules corresponding to categories of diagnoses, and uses skip logic to allow the interviewer to skip questions or modules if certain diagnostic criteria are indicated. Most sections begin with an entry question that would allow the interviewer to "skip" the associated questions if not met. For all diagnoses symptoms are coded as present, subthreshold, or absent. It assesses for both current and lifetime diagnoses and prompts the interviewer to document age of illness onset and to rate current illness severity (Glasofer et al., 2015).
Time Frame 26 weeks

Outcome Measure Data

Analysis Population Description
There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.
Arm/Group Title Arm 1: PE Via Telemedicine Arm 2: PE in Person
Arm/Group Description PE via telemedicine Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine PE in person In Person: PE therapy delivered in person at the VAMC
Measure Participants 64 68
Base SCID % Depression DX
75.6
118.1%
86.5
127.2%
Post SCID % Depression DX
66.7
104.2%
52.9
77.8%
Month 3 SCID % Depression DX
58.3
91.1%
40.0
58.8%
Month 6 SCID % Depression DX
62.5
97.7%
42.1
61.9%
Base SCID % Panic DX
30.0
46.9%
33.0
48.5%
Post SCID % Panic DX
50
78.1%
28
41.2%
Month 3 SCID % Panic DX
40
62.5%
20
29.4%
Month 6 SCID % Panic DX
38.5
60.2%
53.8
79.1%
11. Secondary Outcome
Title Prior Experience With Computer and Audiovisual Technology
Description The Prior Experience With Technology questionnaire is an 8-item short measure to learn more about participants' prior experiences and comfort level with computers and audiovisual technology. For 8 different technological devices, the measure asks if the participant has the device in his/her home (i.e. Is there a telephone in your home)? Subsequent questions determine whether the patient is comfortable using that device or, if he/she does not own one, if he/she would be willing to learn to use one. Devices assessed include telephone, television, stereo, video player (e.g. VCR, DVD), computer, internet, e-mail, and audiovisual conferencing technology. These data may help identify whether these variables are associated with clinical outcome.
Time Frame Week 0

Outcome Measure Data

Analysis Population Description
The outcome data for this measure is not available because there was not enough sufficient responses to generate analyses.
Arm/Group Title Arm 1: PE Via Telemedicine Arm 2: PE in Person
Arm/Group Description PE via telemedicine Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine PE in person In Person: PE therapy delivered in person at the VAMC
Measure Participants 0 0

Adverse Events

Time Frame
Adverse Event Reporting Description There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed (see participant flow and baseline characteristics sections). We are reporting adverse event statistics on the basis of total enrollment.
Arm/Group Title Arm 1: PE Via Telemedicine Arm 2: PE in Person
Arm/Group Description PE via telemedicine Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine PE in person In Person: PE therapy delivered in person at the VAMC
All Cause Mortality
Arm 1: PE Via Telemedicine Arm 2: PE in Person
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Arm 1: PE Via Telemedicine Arm 2: PE in Person
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/74 (0%) 1/76 (1.3%)
Psychiatric disorders
Death 0/74 (0%) 0 1/76 (1.3%) 1
Other (Not Including Serious) Adverse Events
Arm 1: PE Via Telemedicine Arm 2: PE in Person
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/74 (0%) 0/76 (0%)

Limitations/Caveats

The study lacked a third group of participants receiving an alternative intervention to compare PE-HBT with a standard control-group. The achieved effect sizes were less than those typically evident in PE treatment outcome studies

More Information

Certain Agreements

Principal Investigators are NOT 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 Ron Acierno, PhD
Organization Medical University of South Carolina
Phone 843-792-2949
Email acierno@musc.edu
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01102764
Other Study ID Numbers:
  • IAC 09-040
  • 19695
First Posted:
Apr 13, 2010
Last Update Posted:
Mar 4, 2019
Last Verified:
Nov 1, 2018