A Randomized Clinical Trial of Cognitive-Behavioral Treatment for Post-Traumatic Stress Disorders in Women

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

CSP #494 - A Randomized Clinical Trial of Cognitive-Behavioral Treatment for PTSD in Women (PTSD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00032617
• Other study ID #: 494
• Status: Completed
• Phase: Phase 3
• First received: March 27, 2002
• Last updated: September 22, 2010
• Start date: August 2002
• Est. completion date: April 2006

Study information

• Verified date: September 2010
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of the proposed DVA cooperative study is to evaluate the efficacy of exposure therapy for treating PTSD and associated problems in female veterans and active duty military personnel. We propose to compare exposure therapy, Prolonged Exposure, with a comparison therapy that focuses on current problems, Present Centered Therapy.

The study is a randomized clinical trial involving 384 female veterans and active duty personnel in 11 VA medical centers and 1 DoD medical center. All subjects, even self-referrals, will enter the study through referrals by mental health clinicians at the participating sites. Following informed consent, subjects will be screened for inclusion and exclusion diagnoses. If they meet these criteria and agree to participate, they will be randomly assigned to one of the two treatments, which will occur weekly for 10 weeks. Subjects will be assessed before treatment, immediately following treatment, and 3 and 6 months after the end of treatment. The primary outcome is PTSD severity. Secondary outcomes are anxiety and depression. Exploratory outcomes include associated features of PTSD, such as dissociation and substance abuse; psychosocial functioning, quality of life, physical health, satisfaction with treatment, and service utilization. Both treatments will be described in detail in a treatment manual and monitored intensively to ensure that they are administered correctly.

Description:

Intervention: Patients will be randomized to one of two interventions: Prolonged Exposure (PE) consisting of 10 weekly treatment sessions that include education about and exposure to the memories of the trauma to which the patient was engaged; or Present Center Therapy (PCT), which will consist of a control therapy of the same duration that will provide emotional support for the trauma victim.

Primary Hypothesis: Prolonged Exposure (PE) will be more effective than Present-Centered Therapy (PCT) for the treatment of PTSD due to military-related trauma in women veterans. PE specifically targets PTSD symptoms, and the CAPS, our primary outcome measure. The Clinician Administered PTSD Scale (CAPS) is considered to be the gold-standard for PTSD assessment.

Secondary Hypothesis: PE will be more effective than PCT for treating the anxiety and depression that often are comorbid with PTSD.

Study Abstract: As noted in a recent report on the VA Women's Health Project, it is important to study women veterans because they are increasingly seeking VA health care. For many women veterans, Posttraumatic Stress Disorder (PTSD) is a specific healthcare concern that is associated with substantial psychosocial and functional disability.

The study was proposed in response to the Research Priority Announcement on Posttraumatic Stress Disorder research issued August 1, 1997, as a study aimed a special subpopulation of VA patients with PTSD: women veterans who have been traumatized during their military service.

The first planning meeting for the study was held January 20-21, 2000 in Washington, DC. The protocol was submitted on August 1, 2000; it was reviewed and approved by the Cooperative Studies Evaluation Committee on October 10, 2000. Intake of training cases is expected to begin 01/01/2002.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• female veterans or active duty personnel with a current diagnosis of PTSD due to any type of trauma;

• have experienced trauma no less than 3 months prior to entering the trial;

• have at least one clear memory of the trauma that caused their PTSD (sufficient for constructing a scene to be used in PE);

• consent to be randomized into treatment;

• not receive other psychotherapy for PTSD during the 10 weeks of active treatment;

• psychotherapy for other problems, brief check-ins with an existing therapist, and attendance at self-help groups will be allowed;

• if on psychoactive medication be on a stable medication regimen for a minimum of 2 months prior to entering the trial.

Exclusion Criteria:

• current substance dependence;

• prior substance dependence that has not been in remission at least 3 months;

• any current psychotic symptoms; current Mania or Bipolar Disorder;

• prominent current suicidal or homicidal ideation;

• any severe cognitive impairment or history of Organic Mental Disorder;

• current involvement in a violent relationship;

• self-mutilation within the past 6 months.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Procedure:
• Prolonged Exposure
trauma-focused exposure therapy
• Present Centered Therapy
therapy that focuses on current problems

Locations

Country	Name	City	State
United States	New Mexico VA Health Care System, Albuquerque	Albuquerque	New Mexico
United States	VA Maryland Health Care System, Baltimore	Baltimore	Maryland
United States	VA Medical Center, Bay Pines	Bay Pines	Florida
United States	Walter Reed (DCI-HUC)	Bethesda	Maryland
United States	VA Medical Center, Jamaica Plain Campus	Boston	Massachusetts
United States	VA Medical Center, Cincinnati	Cincinnati	Ohio
United States	VA Medical Center, Cleveland	Cleveland	Ohio
United States	VA North Texas Health Care System, Dallas	Dallas	Texas
United States	Atlanta VA Medical and Rehab Center, Decatur	Decatur	Georgia
United States	VA Eastern Colorado Health Care System, Denver	Denver	Colorado
United States	Southeast Veterans Healthcare System, New Orleans	New Orleans	Louisiana
United States	VA Medical Center, Portland	Portland	Oregon
United States	VA Medical & Regional Office Center	White River Junction	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	summing totals of 17 DSM-IV symptoms		10 weeks	No