Present- Versus Past-focused Therapy for PTSD and Substance Use Disorder
2 de mayo de 2019 actualizado por: Karen Krinsley, VA Boston Healthcare System
Pilot Study of an Integrated Exposure-Based Model for Posttraumatic Stress Disorder and Substance Use Disorder
This study compares Creating Change, a new past-focused behavioral therapy for posttraumatic stress disorder (PTSD)/substance use disorder (SUD), to Seeking Safety, an evidence-based present-focused behavioral therapy for PTSD/SUD.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study evaluates a new behavioral therapy model, Creating Change (CC) for PTSD/SUD.
CC helps clients explore the past as a step in their recovery process.
It has major public health relevance in that it is a low-cost, flexible model designed for all trauma and substance abuse types, both genders, and all clinical settings.
It has particular relevance for VA in that many veterans suffer from PTSD and SUD.
The new model demonstrated positive results in two pilot studies.
Tipo de estudio
Intervencionista
Inscripción (Actual)
52
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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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02459
- VA Boston Healthcare 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
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Meet Diagnostic and Statistical Manual (DSM-IV) criteria for current PTSD and current substance use disorder
- Have used a substance in the 60 days prior to intake
- Outpatient
- Plan to stay in Boston for the next 6 months
- If on psychiatric medication, are on a stable regimen for at least 4 weeks prior to participation in the study
- Have a stable mailing address and live nearby enough to come to VA Boston for treatment
- Able to sign informed consent
- Willing to participate in all assessments and urine testing
- Willing to provide a release of information for study staff to contact treaters as needed for clinical concerns
Exclusion Criteria:
- Any current acute medical condition that would either interfere with the patient's ability to attend treatment, or would be of such severity as to affect the patient's psychological functioning
- Current bipolar I disorder, schizophrenia or other psychotic disorders, mental retardation, or organic mental disorder
- Any obvious clinical sign that the patient is not sufficiently stable to participate in the treatment, or notification by the patient's primary providers that participation would be contraindicated
- Dangerousness that would present a threat to staff or patients (e.g., history of assault within the past 6 months)
- The patient is mandated to treatment
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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Comparador activo: Seeking Safety (SS)
17 sessions of present-focused therapy Seeking Safety
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Seeking Safety is a present-focused, evidence-based cognitive-behavioral therapy for integrated treatment of patients with PTSD/SUD.
It is a cognitive-behavioral therapy comprising 25 topics, each a coping skill relevant to both disorders.
In this study 17 of the 25 topics were conducted, one per weekly, one-hour, individual session.
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Experimental: Creating Change (CC)
17 sessions of past-focused Creating Change
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Creating Change is a past-focused, integrated, cognitive-behavioral therapy for PTSD/SUD.
It has 17 topics, which in this study were delivered in weekly one-hour sessions, in individual format.
The treatment explores how PTSD and SUD arose and interacted across the patient's life, including constructing a narrative of its meaning, processing associated emotions and memories, and exploring themes related to these.
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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 Checklist total score - from baseline through end of treatment and 3-month followup
Periodo de tiempo: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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PTSD symptoms assessed via self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in diagnosis of PTSD on the MINI Neuropsychiatric Interview - from baseline through end of treatment and 3-month followup
Periodo de tiempo: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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PTSD diagnosis as assessed by a trained interviewer
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Addiction Severity Index alcohol composite score - from baseline through end of treatment and 3-month followup
Periodo de tiempo: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Alcohol use and associated problems as measured by blinded-interviewer measure Composite.
These outcome variables will be measured at baseline, end of treatment and 3-month followup.
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Addiction Severity Index drug composite score - from baseline through end of treatment and 3-month followup
Periodo de tiempo: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Drug use and associated problems as measured by blinded-interviewer measure Composite.
These outcome variables will be measured at baseline, end of treatment and 3-month followup.
Urinanlysis/breathalyzer will be obtained to verify ASI self-report.
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Quality of Life Satisfaction & Enjoyment Scale - from baseline through end of treatment and 3-month followup
Periodo de tiempo: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Brief Symptom Inventory-Global Severity Index - from baseline through end of treatment and 3-month followup
Periodo de tiempo: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Beliefs About Substance Use - from baseline through end of treatment and 3-month followup
Periodo de tiempo: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in General Self-Efficacy - from baseline through end of treatment and 3-month followup: Self-report measure
Periodo de tiempo: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Coping Self-Efficacy Scale - from baseline through end of treatment and 3-month followup
Periodo de tiempo: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in World Assumptions Scale - from baseline through end of treatment and 3-month followup
Periodo de tiempo: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Trauma Related Guilt Inventory - from baseline through end of treatment and 3-month followup
Periodo de tiempo: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Karen E. Krinsley, Ph.D., VA Boston Healthcare System
- Investigador principal: Lisa M Najavits, PhD, VA Boston 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.
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 enero de 2011
Finalización primaria (Actual)
1 de marzo de 2015
Finalización del estudio (Actual)
1 de marzo de 2015
Fechas de registro del estudio
Enviado por primera vez
10 de enero de 2011
Primero enviado que cumplió con los criterios de control de calidad
10 de enero de 2011
Publicado por primera vez (Estimar)
11 de enero de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de mayo de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
2 de mayo de 2019
Última verificación
1 de mayo de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SPLA-CX000308-01 (VA CSRD)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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. .