Treatment for Veterans With Military Sexual Trauma
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness of Cognitive Processing Therapy (CPT) versus Present-Centered Therapy (PCT) in treating current post-traumatic stress symptoms associated with sexual assault that occurred while veterans were serving in the military.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study is designed to provide insight into effective treatment of veterans with current Post Traumatic Stress Disorder [PTSD] that resulted from sexual assault that occurred during their active military duty [MST]. This issue is of critical importance, as (1) Congress mandated VA to provide counseling to veterans with sexual trauma. (2) Based on the national MST surveillance data of 1.7 million VA patients, 22% of women and 1% of men have experienced MST. (3) With 20,000 Operation Iraqi Freedom [OIF] veterans having already sought healthcare since deployment, VA will begin to serve a higher percentage of women from combat zones, where the epidemiology of sexual assault and the efficacy of conventional treatments are essentially unknown. Finally, (4) findings from our MST-Study of 270 women veterans strongly suggests that MST is clinically different from civilian adult or child sexual trauma, bringing into question whether conventional civilian-based treatment will be effective with MST veterans.
Cognitive Processing Therapy (CPT) is a therapy developed to treat civilian rape-related PTSD. The efficacy of CPT has been shown with female civilians with sexual assault histories. However, there has not been any research examining the effectiveness of CPT in treating symptoms associated with sexual assault that occurs in military settings. The difference clinically between sexual assault in civilian and military settings is important, as revealed by our clinical experience and empirical findings. In working with veterans with MST for over 13 years we have noted that the assaults are often perpetrated by trusted military personnel and the victim is often without access to immediate treatment or care. Empirically, our research demonstrates that MST is associated with higher rates of PTSD compared to civilian sexual assault.
The primary goal of the study is to evaluate the effectiveness of CPT treatment versus Present Centered Therapy (PCT) for PTSD and associated symptoms resulting from MST. The study objectives will be met by three levels of hypotheses. Hypotheses focus on the primary outcome (PTSD symptoms), confirmatory outcomes (depression symptoms, quality of life), and exploratory outcomes (cost and utilization). Based on the results of the study, we intend to produce an educational CD-ROM, which will include a training manual to educate practitioners on the use of the more effective treatment with veterans. It will be designed for administration by clinicians who represent a range of disciplines (e.g., psychologists, nurses, social workers) and levels of training (e.g., bachelor through doctoral degrees).
This is a randomized controlled clinical trial involving veterans from the VA North Texas Healthcare System (VANTHCS). Data will be obtained from face-to-face interview and written questionnaires at baseline, treatment completion, 2-month, 4-month, and 6-month follow-ups. Patients will be randomized to one of two conditions (CPT or PCT). Patients will receive biweekly sessions of the respective individual therapy from trained therapists for a 6-week period (total of 12 sessions), followed by scheduled assessments. The primary endpoint is the CAPS score, a measure of PTSD severity. Secondary endpoints include anxiety, depression, quality of life, and healthcare utilization.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1 Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT). |
Behavioral: Cognitive Processing Therapy
CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape.
Other Names:
|
| Active Comparator: Arm 2 Participants receive 12 biweekly sessions of Present Centered Therapy (PCT). |
Behavioral: Present-Centered Therapy
PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- PTSD Checklist (PCL) [Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment]
The PCL is a 17-item self-report measure that is commonly used in clinical and research settings. All 17 items are summed to compute a total score of PTSD symptomatology. Scores for the PCL range from 17-85, with 85 indicating severe PTSD symptomatology. The PCL has strong psychometric properties and mirrors the symptomatology of the DSM.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Veteran (female or male) from any era with a current diagnosis of PTSD due to MST
-
Experienced MST no less than 3 months prior to entering the trial
-
Identify that MST is the trauma that is causing the worst current distress (if other traumas also experienced)
-
Have at least one clear memory of the trauma (sufficient to write impact statement)
-
Consent to be randomized into treatment
-
Not receive other psychotherapy during the 6 weeks of active treatment
-
(if on psychoactive medications) if new antidepressant, be on stable medication regimen for a minimum of 6 weeks prior to entering the trial (if recent changes to antidepressant dosage or additions or changes of antipsychotic or anti-anxiety medication, eligible immediately)
Exclusion Criteria:
-
Current substance dependence
-
Prior substance dependence that has not been in remission for at least 3 months
-
Any current psychotic symptoms
-
Current mania or unstable Bipolar Disorder
-
Prominent current suicidal or homicidal features
-
Any severe cognitive impairment or history of Organic Mental Disorder
-
Current involvement in a violent relationship
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA North Texas Health Care System, Dallas | Dallas | Texas | United States | 75216 |
Sponsors and Collaborators
- US Department of Veterans Affairs
Investigators
- Principal Investigator: Alina M Suris, PhD, VA North Texas Health Care System, Dallas
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D4445-R
- IRB 06-036
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Cognitive Processing Therapy (CPT) | Present Centered Therapy (PCT) |
|---|---|---|
| Arm/Group Description | Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT). Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape. | Participants receive 12 biweekly sessions of Present Centered Therapy (PCT). Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD. |
| Period Title: Overall Study | ||
| STARTED | 72 | 57 |
| COMPLETED | 44 | 44 |
| NOT COMPLETED | 28 | 13 |
Baseline Characteristics
| Arm/Group Title | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Arm/Group Description | Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT). Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape. | Participants receive 12 biweekly sessions of Present Centered Therapy (PCT). Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD. | Total of all reporting groups |
| Overall Participants | 52 | 34 | 86 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
44.6
(10.5)
|
48.4
(10.7)
|
46.1
(10.1)
|
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
51
98.1%
|
34
100%
|
85
98.8%
|
| >=65 years |
1
1.9%
|
0
0%
|
1
1.2%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
43
82.7%
|
30
88.2%
|
73
84.9%
|
| Male |
9
17.3%
|
4
11.8%
|
13
15.1%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
52
100%
|
34
100%
|
86
100%
|
| PTSD Checklist (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
65.96
(10.63)
|
65.21
(13.25)
|
65.65
(11.69)
|
Outcome Measures
| Title | PTSD Checklist (PCL) |
|---|---|
| Description | The PCL is a 17-item self-report measure that is commonly used in clinical and research settings. All 17 items are summed to compute a total score of PTSD symptomatology. Scores for the PCL range from 17-85, with 85 indicating severe PTSD symptomatology. The PCL has strong psychometric properties and mirrors the symptomatology of the DSM. |
| Time Frame | Baseline assessment and then 4, follow-up assessments: at treatment completion, 2-month post treatment, 4-month post treatment, and 6-month post treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Numbers differ from enrollment due to participants excluded from data analysis for poor psychotherapeutic fidelity. |
| Arm/Group Title | Cognitive Processing Therapy (CPT) | Present Centered Therapy (PCT) |
|---|---|---|
| Arm/Group Description | Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT). Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape. | Participants receive 12 biweekly sessions of Present Centered Therapy (PCT). Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD. |
| Measure Participants | 52 | 34 |
| Baseline |
65.53
(1.67)
|
65.40
(2.00)
|
| Posttreatment (12 Sessions) |
51.39
(2.02)
|
57.89
(2.18)
|
| 2-month follow-up |
52.71
(1.98)
|
59.35
(2.24)
|
| 4-month follow-up |
54.98
(1.99)
|
55.22
(2.15)
|
| 6-month follow-up |
50.52
(1.97)
|
56.22
(2.17)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Arm 1 | Arm 2 | ||
| Arm/Group Description | Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT). Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape. | Participants receive 12 biweekly sessions of Present Centered Therapy (PCT). Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD. | ||
All Cause Mortality |
||||
| Arm 1 | Arm 2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Arm 1 | Arm 2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/72 (11.1%) | 5/57 (8.8%) | ||
| Psychiatric disorders | ||||
| Anxiety | 3/72 (4.2%) | 3 | 2/57 (3.5%) | 2 |
| Hospitalization | 5/72 (6.9%) | 5 | 3/57 (5.3%) | 3 |
Other (Not Including Serious) Adverse Events |
||||
| Arm 1 | Arm 2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/72 (0%) | 0/57 (0%) | ||
Limitations/Caveats
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. Alina Suris |
|---|---|
| Organization | VA North Texas Health Care System |
| Phone | 2148572312 |
| alina.suris@va.gov |
- D4445-R
- IRB 06-036