Treatment for Veterans With Military Sexual Trauma
Primary Purpose
Stress Disorders, Post-Traumatic, Depressive Symptoms, Anxiety Symptoms
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Processing Therapy
Present-Centered Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Stress Disorders, Post-Traumatic, Cognitive Processing Therapy, Military sexual trauma, Psychology, Military, Veterans, Rape, Veterans, psychology, Healthcare utilization
Eligibility 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
Sites / Locations
- VA North Texas Health Care System, Dallas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).
Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).
Outcomes
Primary Outcome Measures
PTSD Checklist (PCL)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00371644
First Posted
August 31, 2006
Last Updated
January 6, 2015
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00371644
Brief Title
Treatment for Veterans With Military Sexual Trauma
Official Title
Manualized Treatment for Veterans With Military Sexual Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Depressive Symptoms, Anxiety Symptoms, Quality of Life
Keywords
Stress Disorders, Post-Traumatic, Cognitive Processing Therapy, Military sexual trauma, Psychology, Military, Veterans, Rape, Veterans, psychology, Healthcare utilization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy
Other Intervention Name(s)
CPT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Present-Centered Therapy
Other Intervention Name(s)
PCT
Intervention Description
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.
Primary Outcome Measure Information:
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alina M Suris, PhD
Organizational Affiliation
VA North Texas Health Care System, Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA North Texas Health Care System, Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23325750
Citation
Suris A, Link-Malcolm J, Chard K, Ahn C, North C. A randomized clinical trial of cognitive processing therapy for veterans with PTSD related to military sexual trauma. J Trauma Stress. 2013 Feb;26(1):28-37. doi: 10.1002/jts.21765. Epub 2013 Jan 16.
Results Reference
result
PubMed Identifier
25269124
Citation
Holliday R, Link-Malcolm J, Morris EE, Suris A. Effects of cognitive processing therapy on PTSD-related negative cognitions in veterans with military sexual trauma. Mil Med. 2014 Oct;179(10):1077-82. doi: 10.7205/MILMED-D-13-00309.
Results Reference
result
PubMed Identifier
25260214
Citation
Mullen K, Holliday R, Morris E, Raja A, Suris A. Cognitive processing therapy for male veterans with military sexual trauma-related posttraumatic stress disorder. J Anxiety Disord. 2014 Dec;28(8):761-4. doi: 10.1016/j.janxdis.2014.09.004. Epub 2014 Sep 21.
Results Reference
result
PubMed Identifier
29905663
Citation
Holliday R, Holder N, Monteith LL, Suris A. Decreases in Suicide Cognitions After Cognitive Processing Therapy Among Veterans With Posttraumatic Stress Disorder Due to Military Sexual Trauma: A Preliminary Examination. J Nerv Ment Dis. 2018 Jul;206(7):575-578. doi: 10.1097/NMD.0000000000000840.
Results Reference
derived
PubMed Identifier
29848187
Citation
Wiblin J, Holder N, Holliday R, Suris A. Predictors of Unbearability, Unlovability, and Unsolvability in Veterans With Military-Sexual-Trauma-Related Posttraumatic Stress Disorder. J Interpers Violence. 2021 Apr;36(7-8):3814-3830. doi: 10.1177/0886260518777554. Epub 2018 May 31.
Results Reference
derived
PubMed Identifier
29573657
Citation
Holliday R, Holder N, Suris A. Reductions in self-blame cognitions predict PTSD improvements with cognitive processing therapy for military sexual trauma-related PTSD. Psychiatry Res. 2018 May;263:181-184. doi: 10.1016/j.psychres.2018.03.007. Epub 2018 Mar 14.
Results Reference
derived
PubMed Identifier
28485687
Citation
Holliday RP, Holder ND, Williamson MLC, Suris A. Therapeutic response to Cognitive Processing Therapy in White and Black female veterans with military sexual trauma-related PTSD. Cogn Behav Ther. 2017 Sep;46(5):432-446. doi: 10.1080/16506073.2017.1312511. Epub 2017 May 9.
Results Reference
derived
PubMed Identifier
26198645
Citation
Williams R, Holliday R, Clem M, Anderson E, Morris EE, Suris A. Borderline Personality Disorder and Military Sexual Trauma: Analysis of Previous Traumatization and Current Psychiatric Presentation. J Interpers Violence. 2017 Aug;32(15):2223-2236. doi: 10.1177/0886260515596149. Epub 2015 Jul 21.
Results Reference
derived
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Treatment for Veterans With Military Sexual Trauma
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