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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 31, 2006 | ||||||||
| Last Updated Date | August 18, 2009 | ||||||||
| Start Date ICMJE | February 2007 | ||||||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Clinician Administered PTSD Scale (CAPS) [ 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 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
PTSD severity at end of treatment, and at 2-, 4-, and 6-month follow-ups | ||||||||
| Change History | Complete list of historical versions of study NCT00371644 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE |
Depression, Anxiety, and Quality of Life at end of treatment, and at 2-, 4-, and 6-month follow-ups | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Treatment for Veterans With Military Sexual Trauma | ||||||||
| Official Title ICMJE | Manualized Treatment for Veterans With Military Sexual Trauma | ||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | Suris A, Lind L, Kashner TM, Borman PD, Petty F. Sexual assault in women veterans: an examination of PTSD risk, health care utilization, and cost of care. Psychosom Med. 2004 Sep-Oct;66(5):749-56. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 170 | ||||||||
| Estimated Completion Date | September 2009 | ||||||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00371644 | ||||||||
| Responsible Party | Suris, Alina - Principal Investigator, Department of Veterans Affairs | ||||||||
| Study ID Numbers ICMJE | D4445R, IRB 06-036 | ||||||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||||||
| Verification Date | August 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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