Post Traumatic Stress Disorder Clinical Trial
Official title:
Phase II Efficacy Study on Group Delivery of Effective Treatments for PTSD
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.
Status | Completed |
Enrollment | 86 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 19 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | New Mexico VA Health Care System | Albuquerque | New Mexico |
Lead Sponsor | Collaborator |
---|---|
New Mexico VA Healthcare System |
United States,
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.
Castillo DT : Systematic outpatient treatment of sexual trauma in women: Application of cognitive and behavioral protocols . Cogn Behav Pract 2004 : 11: 352 - 65 .
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. — View Citation
Foa EB, Rothbaum BO, Riggs DS, Murdock TB. Treatment of posttraumatic stress disorder in rape victims: a comparison between cognitive-behavioral procedures and counseling. J Consult Clin Psychol. 1991 Oct;59(5):715-23. — View Citation
Garrick J : Efficacy of PTSD treatment in the VA . VHSJ 2000 : 5: 15-21 .
Keane TM , Fairbank JA , Caddell JM , Zimering RT : Implosive (flooding) therapy reduces symptoms of PTSD in Vietnam combat Veterans . Behav Ther 1989 ; 20: 245 - 60 .
Resick PA, Schnicke MK. Cognitive processing therapy for sexual assault victims. J Consult Clin Psychol. 1992 Oct;60(5):748-56. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in PTSD from baseline on the Clinician Administered PTSD Scale (CAPS) to post-treatment, 3 months, and 6 months later. | Interview administration of the CAPS by independent assessor captures current (past month) and lifetime symptoms and diagnosis of Post-Traumatic Stress Disorder (PTSD). | Baseline, post-treatment, 3 months follow up, 6 months follow up. | No |
Secondary | 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. | Self-report questionnaire measures 8 life-functioning scales summarized by two content scales--Mental and Physical functioning. | Baseline, post-treatment, 3-month follow up, 6-month follow up | No |
Secondary | Change in quality of life from baseline on the Quality of Life Inventory (QOLI) to post-treatment, 3 months, and 6 months later. | QOLI is a self-report questionnaire measuring overall quality of life across 16 domains. | Baseline, post-treatment, 3-month follow up, 6-month follow up | No |
Secondary | Change in PTSD from baseline to points during treatment with the PTSD Symptom Checklist (PCL). | The PCL is a self-report questionnaire measuring 17 PTSD symptoms. | Baseline, after each treatment block (every 5 weeks), post-treatment | No |
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