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Treatment for Veterans With Military Sexual Trauma
This study is currently recruiting participants.
Study NCT00371644   Information provided by Department of Veterans Affairs
First Received: August 31, 2006   Last Updated: August 18, 2009   History of Changes

August 31, 2006
August 18, 2009
February 2007
September 2009   (final data collection date for primary outcome measure)
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 ]
PTSD severity at end of treatment, and at 2-, 4-, and 6-month follow-ups
Complete list of historical versions of study NCT00371644 on ClinicalTrials.gov Archive Site
 
Depression, Anxiety, and Quality of Life at end of treatment, and at 2-, 4-, and 6-month follow-ups
 
Treatment for Veterans With Military Sexual Trauma
Manualized Treatment for Veterans With Military Sexual Trauma

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.

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.

 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
  • Stress Disorders, Post-Traumatic
  • Depressive Symptoms
  • Anxiety Symptoms
  • Quality of Life
  • Behavioral: Cognitive Processing Therapy
  • Behavioral: Present-Centered Therapy
  • Experimental: Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).
  • Active Comparator: Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
170
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Veteran (female or male) from any era with a current diagnosis of PTSD due to MST
  2. Experienced MST no less than 3 months prior to entering the trial
  3. Identify that MST is the trauma that is causing the worst current distress (if other traumas also experienced)
  4. Have at least one clear memory of the trauma (sufficient to write impact statement)
  5. Consent to be randomized into treatment
  6. Not receive other psychotherapy during the 6 weeks of active treatment
  7. (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:

  1. Current substance dependence
  2. Prior substance dependence that has not been in remission for at least 3 months
  3. Any current psychotic symptoms
  4. Current mania or unstable Bipolar Disorder
  5. Prominent current suicidal or homicidal features
  6. Any severe cognitive impairment or history of Organic Mental Disorder
  7. Current involvement in a violent relationship
Both
18 Years and older
No
Contact: Christina M Bass, MS (214) 857-0722 ChristinaM.Bass@va.gov
Contact: Alina Suris, PhD (214) 857-0722 alina.suris@va.gov
United States
 
NCT00371644
Suris, Alina - Principal Investigator, Department of Veterans Affairs
D4445R, IRB 06-036
Department of Veterans Affairs
 
Principal Investigator: Alina Suris, PhD VA North Texas Health Care System, Dallas
Department of Veterans Affairs
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP