Clinical trial NCT02069873: Effectiveness of Cognitive, Exposure, and Skills Group Manualized Treatments in Operations Iraqi (OIF)/Operation Enduring Freedom (OEF) Female Veterans
Official title: Phase II Efficacy Study on Group Delivery of Effective Treatments for PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Post Traumatic Stress Disorder
Group
Treatment
Cognitive, Exposure, Skills
Women
Veterans
Lead sponsor: New Mexico VA Healthcare System
Sponsor class: FED
First posted: 2014-02-24
Enrollment: 86
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of PTSD
* Iraq or Afghanistan female Veteran
* Psychiatry stability (no suicide, homicide)
* One clear memory of a trauma
* Stability on psychiatric medications for 1 month

Exclusion Criteria:

* Active substance use/abuse (or in remission less than 3 mo)
* Psychotic symptoms or diagnosis
* Bipolar disorder diagnosis
* Cognitive impairment
* Involvement in a violent relationship
* Self mutilation within past 6 months

Primary outcomes:
measure: Change in PTSD from baseline on the Clinician Administered PTSD Scale (CAPS) to post-treatment, 3 months, and 6 months later.
timeFrame: Baseline, post-treatment, 3 months follow up, 6 months follow up.
Secondary outcomes:
measure: Change in mental and physical functioning from baseline on the Health Related Quality of Life (SF36) to post-treatment, 3 months, and 6 months later.
timeFrame: Baseline, post-treatment, 3-month follow up, 6-month follow up
measure: Change in quality of life from baseline on the Quality of Life Inventory (QOLI) to post-treatment, 3 months, and 6 months later.
timeFrame: Baseline, post-treatment, 3-month follow up, 6-month follow up
measure: Change in PTSD from baseline to points during treatment with the PTSD Symptom Checklist (PCL).
timeFrame: Baseline, after each treatment block (every 5 weeks), post-treatment
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: New Mexico VA Health Care System
state: New Mexico
Study officials:
affiliation: New Mexico VA Healthcare System
name: Diane T Castillo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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citation: Resick PA, Schnicke MK. Cognitive processing therapy for sexual assault victims. J Consult Clin Psychol. 1992 Oct;60(5):748-56. doi: 10.1037//0022-006x.60.5.748.
citation: Cahill SP, Rothbaum BO, Resick P, & Follette VM. Cognitive-behavioral therapy for adults. In E. B. Foa, T. M. Keane, M. J. Friedman, & J. A. Cohen (Eds.), Effective treatments for PTSD: Practice Guidelines from the International Society for Traumatic Stress Studies (pp. 139-222). New York: The Guildford Press, 2009.
citation: Garrick J : Efficacy of PTSD treatment in the VA . VHSJ 2000 : 5: 15-21 .
citation: Schnurr PP, Friedman MJ, Foy DW, Shea MT, Hsieh FY, Lavori PW, Glynn SM, Wattenberg M, Bernardy NC. Randomized trial of trauma-focused group therapy for posttraumatic stress disorder: results from a department of veterans affairs cooperative study. Arch Gen Psychiatry. 2003 May;60(5):481-9. doi: 10.1001/archpsyc.60.5.481.
citation: Castillo DT : Systematic outpatient treatment of sexual trauma in women: Application of cognitive and behavioral protocols . Cogn Behav Pract 2004 : 11: 352 - 65 .
citation: Castillo DT, C' de Baca J, Qualls C, Bornovalova MA. Group exposure therapy treatment for post-traumatic stress disorder in female veterans. Mil Med. 2012 Dec;177(12):1486-91. doi: 10.7205/milmed-d-12-00186.