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Web-delivery of Evidence-based, Psychosocial Treatment for Substance Use Disorders (CTN-0044)

6 de julio de 2017 actualizado por: New York State Psychiatric Institute

NIDA-CTN-0044: Web-delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders Using the Therapeutic Education System (TES)

The main objective of this study is to evaluate the effectiveness of including an interactive, web-based version of the Community Reinforcement Approach (CRA), called the Therapeutic Education System (TES), as part of community-based, outpatient substance abuse treatment.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The principal objective of the planned trial is to evaluate the effectiveness of including an interactive, web-based version of the Community Reinforcement Approach (CRA), called the Therapeutic Education System (TES), as part of community-based, outpatient substance abuse treatment. CRA is a cognitive-behavioral intervention which seeks to give patients skills to achieve and maintain abstinence and improve social functioning and is often paired with contingency management, where patients earn rewards contingent upon drug negative urines. CRA is an intensive treatment, generally delivered in individual sessions 2 to 3 times per week. Thus, it is expensive and time-consuming to deliver, to train clinical staff, and to provide supervision to maintain clinical staff skill. However, because CRA is oriented toward knowledge and skills, it lends itself to being delivered by computer, using computer-interactive learning technologies.

Individuals accepted into community-based outpatient treatment for substance use disorders (excluding those receiving opioid pharmacotherapy for opioid dependence) will be eligible to participate. This is a multi-site, controlled trial, using NIDA's Clinical Trials Network platform, at approximately 10 Community Treatment Programs, in which participants (N = approximately 500) will be randomized to receive 12 weeks of either: (1) Treatment-as-Usual (TAU), reflecting standard treatment at the collaborating treatment programs in which participants are enrolled, or (2) a modification of TAU which includes access to the TES. It is hypothesized that access to TES will improve substance use outcome and retention in outpatient treatment.

Computer interactive interventions like TES have the potential to deliver science-based psychosocial treatments with high fidelity and cost-effectiveness while conserving clinician time to focus on monitoring and addressing patients' needs. If found to be effective, TES could substantially advance the substance abuse treatment system by improving quality of care delivered, increasing availability of treatment slots by extending and leveraging the efforts of clinical staff, and projecting treatment to rural and other underserved areas.

Tipo de estudio

Intervencionista

Inscripción (Actual)

507

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

  • Estados Unidos
    • Connecticut
      • Danbury, Connecticut, Estados Unidos, 06810
        • MCCA: Midwestern CT Council on Alcoholism
    • Florida
      • Orlando, Florida, Estados Unidos, 32856
        • The Center for Drug Free Living
    • Hawaii
      • Waipahu, Hawaii, Estados Unidos, 96797
        • Hina Mauka
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46208
        • Midtown Community Mental Health Center
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21214
        • Harbel Prevention and Recovery Center
    • Massachusetts
      • Fall River, Massachusetts, Estados Unidos, 02720
        • Stanley Street Treatment and Resources (SSTAR)
    • New York
      • West Hempstead, New York, Estados Unidos, 11552
        • Project Outreach
    • Oregon
      • Eugene, Oregon, Estados Unidos, 97402
        • Willamette Family, Inc.
    • Texas
      • Dallas, Texas, Estados Unidos, 75208
        • Homeward Bound
    • Washington
      • Everett, Washington, Estados Unidos, 98201
        • Evergreen Manor

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 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Male and female patients, 18 years or older, accepted for outpatient, substance abuse treatment at a participating study site.
  • Self-report any substance use problem (including alcohol, as long as they also report other drug use in addition to alcohol).
  • Self-report recent drug use.
  • Within 30 days of initiating treatment at a collaborating study site.
  • Self-report a planned substance abuse treatment episode of at least 3 months.

Exclusion Criteria:

  • Receiving opioid replacement medication.
  • Plan to move out of the area within the next 3 months.
  • Insufficient ability to provide informed consent.
  • Insufficient ability to use English to participate meaningfully in the consent process, the interventions or research assessments.

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
Experimental: Therapeutic Education System (TES)
Participants randomized to this arm will replace approximately 2 hours of Standard Treatment with the Therapeutic Education System (TES) (comprised of a web-based version of the Community Reinforcement Approach and contingency management).
Conductual: Therapeutic Education System (TES)
Participants will received modified treatment-as-usual plus the computerized psychosocial intervention (Therapeutic Education System), including contingency management. Participants will be asked to use the self-directed TES intervention twice weekly and will be asked to complete 2 modules during each session (for a total of 4 modules per week) during the 12-week intervention. Participants will receive incentives contingent primarily upon abstinence from drugs of abuse and, secondarily, upon completion of TES modules.
Otros nombres:
  • TES
  • Therapeutic Education System
Otro: Treatment-as-Usual (TAU)
Participants randomized to TAU will receive standard treatment offered and prescribed, as usual, in the outpatient substance abuse treatment program.
Conductual: Treatment-as-Usual (TAU)
Participants in this condition will receive TAU, consisting of standard treatment offered at each collaborating CTP and will reflect the model of treatment typically provided to most individuals in outpatient, community-based substance abuse treatment settings in the U.S. These sessions will consist of a combination of group and individual counseling.
Otros nombres:
  • TAU
  • Tratamiento estándar
  • Tratamiento como de costumbre

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Reduced Substance Use and Improved Treatment Retention
Periodo de tiempo: 12-week Treatment Phase

Compared to patients assigned to Treatment as Usual (TAU), patients assigned to modified TAU plus the Therapeutic Education System (Modified TAU + TES) will have:

  1. reduced substance use (measured by a combination of self-report confirmed by urine toxicology) and
  2. better retention in treatment at their community-based treatment programs.
12-week Treatment Phase

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Effectiveness
Periodo de tiempo: 12-week treatment phase, 3- and 6-months post treatment
To evaluate the relative effectiveness of TAU vs. modified TAU + TES on several secondary outcome measures, including measures of HIV risk behavior, psychosocial functioning (in areas of criminal activity, health status improvement, psychological status, family/social relationships, and employment, and treatment acceptability (based on participant feedback).
12-week treatment phase, 3- and 6-months post treatment
Sustained outcome
Periodo de tiempo: 3- and 6-months post treatment
To evaluate if improved substance use and retention outcomes are maintained 3- and 6-months post-intervention.
3- and 6-months post treatment
Economic Analysis
Periodo de tiempo: 12-week treatment phase, 3- and 6-months post treatment
To perform a comprehensive economic analysis of including TES in TAU to inform decisions regarding adoption of this new therapeutic tool (assessing incremental costs per increased abstinence time and quality adjusted life year). The economic analyses are clinically important, as even if the computerized intervention is shown to be effective, it may not be adopted in community-based treatment programs unless it is shown to be cost-effective due to the considerable financial constraints in such treatment settings.
12-week treatment phase, 3- and 6-months post treatment
Coping Skills
Periodo de tiempo: 12-week treatment phase, 3- and 6-months post treatment
To examine coping skills acquisition as a treatment process factor that may underlie changes observed during treatment.
12-week treatment phase, 3- and 6-months post treatment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

New York State Psychiatric Institute

Colaboradores

National Institute on Drug Abuse (NIDA)

Investigadores

  • Investigador principal: Edward V Nunes, MD, NIDA Clinical Trials Network - Long Island Regional Node

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

Enlaces Útiles

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 2010

Finalización primaria (Actual)

1 de junio de 2012

Finalización del estudio (Actual)

1 de septiembre de 2012

Fechas de registro del estudio

Enviado por primera vez

14 de abril de 2010

Primero enviado que cumplió con los criterios de control de calidad

14 de abril de 2010

Publicado por primera vez (Estimar)

15 de abril de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de julio de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

6 de julio de 2017

Última verificación

1 de julio de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NYSPI #6051
  • U10DA013035 (Subvención/contrato del NIH de EE. UU.)
  • NIDA-CTN-0044 (Otro identificador: NIDA CTN Protocol Number)

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. .

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