- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02069873
Effectiveness of Cognitive, Exposure, and Skills Group Manualized Treatments in Operations Iraqi (OIF)/Operation Enduring Freedom (OEF) Female Veterans
20 de febrero de 2014 actualizado por: Diane T. Castillo, Ph.D., New Mexico VA Healthcare System
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
86
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87108
- New Mexico VA Health Care System
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
19 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 16-Week Group Treatment
The 16-week treatment group will contain 3 blocks of treatment (exposure, cognitive, skills) with order randomized within the treatment.
The first and last group session are considered inactive treatment sessions.
The group treatment will be provided weekly.
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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.
Otros nombres:
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Sin intervención: Wait List Control
The Wait List Control group will receive minimal attention, as they will meet bi-monthly for supportive sessions with the study psychologist.
The study psychologist will not introduce any active treatment in the individual sessions.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in PTSD from baseline on the Clinician Administered PTSD Scale (CAPS) to post-treatment, 3 months, and 6 months later.
Periodo de tiempo: Baseline, post-treatment, 3 months follow up, 6 months follow up.
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Interview administration of the CAPS by independent assessor captures current (past month) and lifetime symptoms and diagnosis of Post-Traumatic Stress Disorder (PTSD).
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Baseline, post-treatment, 3 months follow up, 6 months follow up.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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.
Periodo de tiempo: Baseline, post-treatment, 3-month follow up, 6-month follow up
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Self-report questionnaire measures 8 life-functioning scales summarized by two content scales--Mental and Physical functioning.
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Baseline, post-treatment, 3-month follow up, 6-month follow up
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Change in quality of life from baseline on the Quality of Life Inventory (QOLI) to post-treatment, 3 months, and 6 months later.
Periodo de tiempo: Baseline, post-treatment, 3-month follow up, 6-month follow up
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QOLI is a self-report questionnaire measuring overall quality of life across 16 domains.
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Baseline, post-treatment, 3-month follow up, 6-month follow up
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Change in PTSD from baseline to points during treatment with the PTSD Symptom Checklist (PCL).
Periodo de tiempo: Baseline, after each treatment block (every 5 weeks), post-treatment
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The PCL is a self-report questionnaire measuring 17 PTSD symptoms.
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Baseline, after each treatment block (every 5 weeks), post-treatment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Diane T Castillo, Ph.D., New Mexico VA Healthcare System
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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. doi: 10.1037//0022-006x.59.5.715.
- 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.
- 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.
- 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. doi: 10.1037//0022-006x.60.5.748.
- 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.
- Garrick J : Efficacy of PTSD treatment in the VA . VHSJ 2000 : 5: 15-21 .
- 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. doi: 10.7205/milmed-d-12-00186.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de abril de 2008
Finalización primaria (Actual)
1 de febrero de 2013
Finalización del estudio (Actual)
1 de febrero de 2013
Fechas de registro del estudio
Enviado por primera vez
14 de febrero de 2014
Primero enviado que cumplió con los criterios de control de calidad
20 de febrero de 2014
Publicado por primera vez (Estimar)
24 de febrero de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
24 de febrero de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
20 de febrero de 2014
Última verificación
1 de febrero de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- W81XWH-08-2-0022
- PT074309 (Otro número de subvención/financiamiento: Department of Defense)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .