Behavioral Treatment for Substance Abuse
1 de diciembre de 2016 actualizado por: Yoshio Nakamura, University of Utah
A Pilot Study of Two Group-based Intervention Programs for Patients With Substance Abuse Problems
This pilot project will evaluate a new mind-body intervention called Mind-Body Bridging (MBB) for reducing substance abuse problems in women who are undergoing a substance abuse treatment program.
The main hypothesis is that MBB will be more effective than the control (standard) intervention program in helping people reduce their craving for illicit substances and/or alcohol.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a randomized clinical pilot study in which MBB will be compared with a standard treatment program for substance abuse.
Both groups will run concurrently over the course of a 10-week period, twice per week.
Tipo de estudio
Intervencionista
Inscripción (Actual)
38
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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Utah
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Salt Lake City, Utah, Estados Unidos, 84102
- House of Hope
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Salt Lake City, Utah, Estados Unidos, 84112
- Pain Research Center, Anesthesiology, University of Utah
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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 55 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Substance abuse or dependence
- Resident/day client in the House of Hope substance abuse treatment program
- Minimum stay in treatment at House of Hope for 3.5 months
- Fluent in English
Exclusion Criteria:
- Psychosis
- Suicide risk
- Dementia
- Significant withdrawal risk
- Severe, unstable depression
- Requires intensive mental health treatment
- Cognitive impairment
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Substance Abuse Education (SED)
The Substance Abuse Education (SED) group will serve as the control intervention in which participants will receive instruction on a variety of topics included in the substance abuse treatment program curriculum.
These will include, but are not limited to, information about anger management, smoking cessation, women's issues, and stress management, and approaches to help reduce cravings.
Each week the TAU group will meet and a House of Hope (HOH) clinical staff member will discuss the above and related issues and how these may help individuals deal with their substance abuse and related psychological issues.
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10 weeks of usual care for substance abuse.
Otros nombres:
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Experimental: Mind-body Bridging (MBB)
Participants in the experimental Mind-Body Bridging (MBB) group, in addition to their usual treatment for substance abuse, will additionally receive instruction on the basics of MBB, and will learn MBB techniques to help deal with their cravings and comorbid psychological conditions.
A workbook will be incorporated into the curriculum to provide MBB participants with daily exercises and activities to help facilitate adherence to the MBB program.
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Two sessions per week for 10 weeks, besides usual care treatment for substance abuse.
Otros nombres:
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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 from baseline in the measure of the Penn Alcohol and Craving Scale
Periodo de tiempo: Week 5 and Week 11
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Change from baseline in the extent of drug and alcohol craving at Week 5 and Week 11, as measured by a modified version of the Penn Alcohol and Craving Scale
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Week 5 and Week 11
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Change from baseline in Alcohol and Drug Use Consequences Scale
Periodo de tiempo: Week 5 and Week 11
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Change from baseline in the measure of alcohol and drug consequences at Week 5 and Week 11, as measured by Alcohol and Drug Use Consequences Scale
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Week 5 and Week 11
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Subjective distress
Periodo de tiempo: Pre (Baseline) Mid (Week 5), Post (Week 11)
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Impact of Events Scale - Revised (IES-R) is a 22-item self-report measure that assesses subjective distress caused by traumatic events.
The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales.
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Pre (Baseline) Mid (Week 5), Post (Week 11)
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Depression
Periodo de tiempo: Pre (Baseline) Mid (Week 5), Post (Week 11)
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The Center for Epidemiologic Studies Depression Scale is one of the most common screening tests to determine an individual's depression quotient.
The test measures depressive feelings and behaviors during the past week.
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Pre (Baseline) Mid (Week 5), Post (Week 11)
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Sleep
Periodo de tiempo: Pre (Baseline) Mid (Week 5), Post (Week 11)
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The Medical Outcomes Study Sleep Scale (MOS-SS) provides an index of sleep problems and incorporates six sleep scale scores: 1) sleep disturbance, 2) sleep adequacy, 3) daytime somnolence, 4) snoring, 5) waking up short of breath with a headache, and 6) quantity of sleep.
The MOS-SS is similar to the Pittsburgh Sleep Quality Index (PSQI) developed at the same time, which includes more questions about sleep disturbance with seven more items overall.
The 1-week assessment is adapted from the normal 4-week retrospective assessment.
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Pre (Baseline) Mid (Week 5), Post (Week 11)
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Mindfulness
Periodo de tiempo: Pre (Baseline) Mid (Week 5), Post (Week 11)
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The Five-facet Mindfulness Questionnaire (FFMQ) comprises five clear, interpretable facets of mindfulness: acting with awareness, observing, describing, non-judging, non-reacting.
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Pre (Baseline) Mid (Week 5), Post (Week 11)
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Self-Compassion
Periodo de tiempo: Pre (Baseline) Mid (Week 5), Post (Week 11)
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Self compassion is measured by the Self-Compassion Scale that comprises 26 items.
Self-compassion is an emotionally positive self-attitude that should protect against the negative consequences of self-judgment, isolation, and rumination (such as depression).
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Pre (Baseline) Mid (Week 5), Post (Week 11)
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Well-being
Periodo de tiempo: Weekly for 11 weeks
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The Well-Being Index (WBI)is a 5-item scale developed and validated by the World Health Organization Collaborating Centre in Mental Health.
The WBI will be used to assess whether participants show any changes in general well-being.
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Weekly for 11 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Yoshi Nakamura, Ph.D., University of Utah
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 agosto de 2011
Finalización primaria (Actual)
1 de agosto de 2012
Finalización del estudio (Actual)
1 de agosto de 2012
Fechas de registro del estudio
Enviado por primera vez
16 de septiembre de 2011
Primero enviado que cumplió con los criterios de control de calidad
20 de septiembre de 2011
Publicado por primera vez (Estimar)
22 de septiembre de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
2 de diciembre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
1 de diciembre de 2016
Última verificación
1 de diciembre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00027696
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. .