Effectiveness of Cognitive, Exposure, and Skills Group Manualized Treatments in Operations Iraqi (OIF)/Operation Enduring Freedom (OEF) Female Veterans
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the efficacy of a group protocol for the delivery of
      evidence-based therapies in comparison to a wait-list control and evaluate the relative
      contribution of exposure, cognitive, and skills blocks of treatment in a 16-session
      manualized group treatment protocol in a sample of OIF/OEF female PTSD veterans. Hyp1:
      Overall improvement is expected in PTSD symptoms compared to a wait-list control group; and
      Hyp2: the exposure and cognitive components are expected to show greater improvement in PTSD
      symptoms than the skills component. Significant results will establish the efficacy of a
      group format for evidence-based treatments for all veterans with a PTSD diagnosis. An
      ancillary part of the study is to examine initial neuropsychological presentation in this
      population and possible changes that may occur as the result of treatment.
    

Detailed description: 
      OBJECTIVES: The objectives are to 1) evaluate the effectiveness of exposure, cognitive, and
      skills (assertiveness/relaxation) therapies within a 16-session group; and 2) evaluate the
      relative contribution of each of three treatment components in a manualized treatment group
      in a sample of OIF/OEF female PTSD veterans. HYPOTHESES: Hypothesis 1. Female OIF/OEF PTSD
      veterans will show reductions in PTSD symptoms and improvement in general functioning after
      participation in a structured group treatment compared to a wait-list control group.
      Hypothesis 2. Exposure and cognitive components will show greater improvement in PTSD
      symptoms than the skills component. RESEARCH DESIGN/BACKGROUND: Based on studies with male
      combat veterans, female civilian rape victims, and female veterans, therapies most effective
      for Posttraumatic Stress Disorder (PTSD) are exposure therapy (1,2,3) and cognitive
      restructuring (4), with less improvement found in other treatments, such as relaxation and
      assertiveness training (5). Most examinations of PTSD treatments have been conducted in an
      individual format, but most PTSD treatments offered in Veterans Administration (VA) hospital
      PTSD programs are conducted in a group format (6). It is critical to determine if these
      therapies work in a group setting, as only one study (7) found no differences in exposure
      therapy compared to a support group. In a comprehensive manualized group treatment protocol
      (8) exposure therapy provided in a group was found effective (9). The aim of the present
      study is to establish the effectiveness of exposure therapy, among other evidence-based
      therapies, in a well designed randomized study. METHODOLOGY: Castillo's (8) manualized group
      treatment protocol for female veterans with PTSD will be modified into a 16-week treatment
      group with a five-week exposure, five-week cognitive, and four-week skills treatment blocks.
      Seventy-two subjects will be assessed with structured interviews (SCID and CAPS) and
      questionnaires (Traumatic Life Events and Quality of Life Inventory) and randomized into one
      of two arms: 16-week immediate treatment, or a 16-week wait-list control, the latter of which
      will be reassessed and offered the study treatment. Oversampling will result in 72 subjects
      in the active treatment arm. Subjects will be reassessed upon completion of treatment or
      wait-list, at 3, and 6 months following treatment. All treatment groups will include three
      female OIF/OEF veterans positive for PTSD. The treatment blocks will be varied into six
      possible orders to control for order effects and the PTSD Symptom Checklist will be
      administered after each treatment block. Data will be collected for three years. CLINICAL
      RELATIONSHIPS: Significant results will contribute to the establishment of evidence-based
      treatments in a manualized treatment group for all veterans with a PTSD diagnosis. FINDINGS:
      Present findings from Dr. Castillo's lab suggest the effectiveness of exposure therapy in a
      group setting.
    

Intervention name(s): 16-Week Group Treatment
Intervention type(s): Behavioral
Intervention description(s): Within the 16-week group treatment, the cognitive block will contain 5 sessions, the exposure block will contain 5 sessions, and the skills block will contain 4 sessions.
Other intervention name(s): Cognitive treatment; Exposure treatment; Skills treatment; Group treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post Traumatic Stress Disorder; Group; Treatment; Cognitive, Exposure, Skills; Women; Veterans