Clinical trial NCT00032617: A Randomized Clinical Trial of Cognitive-Behavioral Treatment for Post-Traumatic Stress Disorders in Women
Official title: CSP #494 - A Randomized Clinical Trial of Cognitive-Behavioral Treatment for PTSD in Women (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stress Disorders, Post-Traumatic
Keywords: PTSD
Stress Disorder
Trauma
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2002-03-28
Enrollment: 284
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: summing totals of 17 DSM-IV symptoms
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System, Denver
state: Colorado
city: Bay Pines
country: United States
facility: VA Medical Center, Bay Pines
state: Florida
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur
state: Georgia
city: New Orleans
country: United States
facility: Southeast Veterans Healthcare System, New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: VA Maryland Health Care System, Baltimore
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed (DCI-HUC)
state: Maryland
city: Boston
country: United States
facility: VA Medical Center, Jamaica Plain Campus
state: Massachusetts
city: Albuquerque
country: United States
facility: New Mexico VA Health Care System, Albuquerque
state: New Mexico
city: Cincinnati
country: United States
facility: VA Medical Center, Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: VA Medical Center, Cleveland
state: Ohio
city: Portland
country: United States
facility: VA Medical Center, Portland
state: Oregon
city: Dallas
country: United States
facility: VA North Texas Health Care System, Dallas
state: Texas
city: White River Junction
country: United States
facility: VA Medical & Regional Office Center
state: Vermont
Study officials:
affiliation: VA Medical & Regional Office Center
name: Matthew J. Friedman, MD PhD
role: STUDY_CHAIR
References:
citation: Stirman SW, Cohen ZD, Lunney CA, DeRubeis RJ, Wiley JF, Schnurr PP. A personalized index to inform selection of a trauma-focused or non-trauma-focused treatment for PTSD. Behav Res Ther. 2021 Jul;142:103872. doi: 10.1016/j.brat.2021.103872. Epub 2021 Apr 26.
citation: Schnurr PP, Lunney CA. Residual symptoms following prolonged exposure and present-centered therapy for PTSD in female veterans and soldiers. Depress Anxiety. 2019 Feb;36(2):162-169. doi: 10.1002/da.22871. Epub 2018 Dec 21.
citation: Lunney CA, Schnurr PP, Cook JM. Comparison of clinician- and self-assessments of posttraumatic stress symptoms in older versus younger veterans. J Trauma Stress. 2014 Apr;27(2):144-51. doi: 10.1002/jts.21908. Epub 2014 Apr 2.
citation: Rosen CS, Greenbaum MA, Schnurr PP, Holmes TH, Brennan PL, Friedman MJ. Do benzodiazepines reduce the effectiveness of exposure therapy for posttraumatic stress disorder? J Clin Psychiatry. 2013 Dec;74(12):1241-8. doi: 10.4088/JCP.13m08592.
citation: Wolf EJ, Lunney CA, Miller MW, Resick PA, Friedman MJ, Schnurr PP. The dissociative subtype of PTSD: a replication and extension. Depress Anxiety. 2012 Aug;29(8):679-88. doi: 10.1002/da.21946. Epub 2012 May 25.
citation: Schnurr PP, Friedman MJ, Engel CC, Foa EB, Shea MT, Chow BK, Resick PA, Thurston V, Orsillo SM, Haug R, Turner C, Bernardy N. Cognitive behavioral therapy for posttraumatic stress disorder in women: a randomized controlled trial. JAMA. 2007 Feb 28;297(8):820-30. doi: 10.1001/jama.297.8.820.