Adapting an Effective CBT for Comorbidity to a Computer-Delivered Format
8 de septiembre de 2022 actualizado por: University of Minnesota
Up to one-half of those in treatment for alcohol use disorder (AUD) has a co-occurring anxiety disorder ("comorbidity"), a condition that marks a high degree of treatment resistance, severity and relapse risk in AUD treatment patients.
The investigators conceptualize comorbidity as a feed-forward system ("vicious cycle", [VC]) of interacting negative affect/stress, drinking motives/behavior, coping skills deficits, environmental circumstances, and neurobiological adaptations.
Based on this model, the investigators developed and validated the VC cognitive-behavioral therapy (VC-CBT) to disrupt this system at several key linkage points.
In a recently completed randomized controlled trial (RCT), the investigators found that adding the VC-CBT to standard AUD inpatient treatment resulted in better alcohol outcomes 4 months following treatment than did adding an anxiety treatment or standard AUD treatment alone.
With a number needed to treat (NNT) index of 8 (relative to standard AUD treatment alone), the VC-CBT could, if broadly disseminated, have a large positive impact on AUD treatment.
Unfortunately, several significant barriers related to the resource- and expertise-intensive delivery of the VC-CBT limit its dissemination potential and, hence, the impact of this otherwise effective treatment.
Therefore, to maximize the public health and scientific potential of the investigators work, the investigators propose to adapt the therapist-delivered VC-CBT to a computer-delivered format to facilitate reliable and economical dissemination of the VC-CBT while maintaining its established efficacy.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The first phase of the work (Year 1) will be to adapt the 6-session therapist-delivered VC-CBT for delivery on an internet-based computer platform.
This work will be done using a standard iterative process for developing e-content in partnership with local technology experts experienced in producing engaging and effective e-learning products.
Approximately 5 patients will be employed in this phase.
The second phase (Years 2 and 3) will be devoted to a single arm pilot trial to test the efficacy of the refined computer-delivered VC-CBT.
The investigators will recruit AUD treatment patients with co-occurring anxiety disorder to receive the computer-delivered VC-CBT (50 patients).
Participants will complete follow-up assessments one and four months following treatment.
Participants will rate user satisfaction and will be evaluated on skill and knowledge acquisition as well as use of the tools in the follow-up period.
Success in the proposed work will serve as pilot data in support of a rigorous randomized clinical trial.
The proposed work aims to provide an easy and inexpensive computer-delivered version of the VC-CBT that has comparable efficacy to the validated but resource-intensive therapist-delivered version.
Achieving this will enable the VC-CBT therapy to benefit more AUD treatment patients and to be more easily studied by other investigators.
Tipo de estudio
Intervencionista
Inscripción (Actual)
59
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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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55408
- University of Minnesota
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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:
- Diagnostic and Statistical Manual-IV diagnosis of panic disorder (with or without agoraphobia), generalized anxiety disorder, or social anxiety disorder within the past 30 days
- Diagnostic and Statistical Manual-IV diagnosis of alcohol dependence within the last 30 days
- inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug) dependence
- alcohol use in the 30 days preceding the beginning of their Lodging Plus (LP) treatment
- willingness and ability to provide informed consent
- minimum of a sixth grade English reading level (deemed necessary to complete study materials); as determined by their being able to read and understand the consent form
- familiarity with computer keyboarding as determined by history
- lives within reasonable driving distance of the Twin Cities and ability to travel to Fairview to allow for in-person follow-up interviews
Exclusion Criteria:
- Active psychosis or mania in the three months preceding the study
- Physical impairment (e.g., blindness, deafness) that interferes with study participation based on self-report or as judged by PI or study physician
- current significant suicide risk (i.e., intention and plan) as deemed by the PI and study physician to be serious and ongoing
- primary PTSD as determined by the Structured Clinical Interview for DSM (SCID) interview
- suspected cognitive impairment that interferes with study participation as informed by the SCID interview or as judged by the PI or study physician
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Computer-based VC-CBT
Computer-based VC-CBT: Three, one-hour computerized therapy sessions delivered on an interactive computerized platform with therapy blocks dedicated to each of three primary modules/goals: 1) psycho-education, 2) skills learning, and 3) individualized practice
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Computer-based VC-CBT: Three, one-hour computerized therapy sessions delivered on an interactive computerized platform with therapy blocks dedicated to each of three primary modules/goals: 1) psycho-education, 2) skills learning, and 3) individualized practice
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
User ratings
Periodo de tiempo: up to 4 days post-treatment
|
Likert scale ratings of understanding, engagement, and applicability to current problems
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up to 4 days post-treatment
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|
Knowledge Acquisition
Periodo de tiempo: up to 4 days post-treatment
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Multiple choice and True/False questions to assess knowledge communicated in program
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up to 4 days post-treatment
|
|
Skills Acquisition
Periodo de tiempo: up to 4 days post-treatment
|
Skill demonstration rated by study staff for accuracy
|
up to 4 days post-treatment
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
16 de abril de 2018
Finalización primaria (Actual)
26 de abril de 2021
Finalización del estudio (Actual)
26 de julio de 2021
Fechas de registro del estudio
Enviado por primera vez
3 de agosto de 2017
Primero enviado que cumplió con los criterios de control de calidad
27 de septiembre de 2017
Publicado por primera vez (Actual)
3 de octubre de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de septiembre de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
8 de septiembre de 2022
Última verificación
1 de septiembre de 2022
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PSYCH-2018-26640
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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