Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care

29 de mayo de 2019 actualizado por: Kristina Sinadinovic, Karolinska Institutet

Comparing Effectiveness and Costs of Internet-based Treatment for Problematic Alcohol Use and Face-to-face Treatment in Addiction Care: A Randomized Controlled Trial

The purpose of this trial is to compare the effectiveness and costs of a five-module Internet-based treatment program (including therapist support) for harmful alcohol use with the effectiveness and cost of the same treatment content delivered face-to-face in specialized addiction treatment. The hypotheses to be tested through this trial are that:

  1. The Internet-based treatment program (including therapist support) is as effective (reducing alcohol consumption) as the same treatment content delivered face-to-face in specialized addiction treatment.
  2. The Internet-based treatment program (including therapist support) is associated with lower cost per treated individual in relation to the achieved effects (in terms of reduced alcohol consumption) compared with the same treatment content delivered face-to-face in specialized addiction treatment.

The design is a two-armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use as well as alcohol dependence, depression, anxiety, quality of life and costs for the treatments. A minimum of 350 participants will be recruited and randomized into two groups:

Intervention group 1: All participants in this group will have access to the five-module Internet-based treatment program for harmful alcohol use and have access to a therapist with training in psychotherapy (CBT) who assists and counsels the participant throughout the program.

Intervention group 2: All participants in this group will attend five face-to-face treatment sessions in specialized addiction treatment.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

303

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

  • Suecia
      • Stockholm, Suecia, 171 77
        • Karolinska Institutet

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • 18 years or older
  • 16 points on Alcohol Use Disorders Identification Test or at least 3 criteria on the International Classification of Diseases (ICD-10) for Alcohol Dependence
  • Resident in Stockholm County

Exclusion Criteria:

  • Lack of understanding of the Swedish language.
  • Doctor's assessment that there is a risk for severe withdrawal symptoms, risk for suicide or mental illness requiring separate care.
  • Doctor's assessment that there is a need for medication for alcohol dependence.

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
Experimental: Internet-based treatment
A five-module Internet-based treatment program for harmful alcohol use (including therapist support) based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.
Conductual: Guide to better alcohol habits
A treatment for harmful alcohol use based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.
Comparador activo: Face-to-face treatment
Same treatment content as in the Internet-based treatment delivered via face-to-face treatment sessions in specialized addiction treatment.
Conductual: Guide to better alcohol habits
A treatment for harmful alcohol use based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Periodo de tiempo: 3 months post-randomization
3 months post-randomization

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Periodo de tiempo: 6 months post-randomization
6 months post-randomization
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Periodo de tiempo: 12 months post-randomization
12 months post-randomization
Number of standard alcohol units consumed in the past 7 days measured with Time Line Follow Back method
Periodo de tiempo: 24 months post-randomization
24 months post-randomization
Alcohol Use Disorders Identification Test score
Periodo de tiempo: 3 months post-randomization
3 months post-randomization
Alcohol Use Disorders Identification Test score
Periodo de tiempo: 6 months post-randomization
6 months post-randomization
Alcohol Use Disorders Identification Test score
Periodo de tiempo: 12 months post-randomization
12 months post-randomization
Alcohol Use Disorders Identification Test score
Periodo de tiempo: 24 months post-randomization
24 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Periodo de tiempo: 3 months post-randomization
3 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Periodo de tiempo: 6 months post-randomization
6 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Periodo de tiempo: 12 months post-randomization
12 months post-randomization
Number of criteria for alcohol dependence according to International Classification of Diseases - 10
Periodo de tiempo: 24 months post-randomization
24 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Periodo de tiempo: 3 months post-randomization
3 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Periodo de tiempo: 6 months post-randomization
6 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Periodo de tiempo: 12 months post-randomization
12 months post-randomization
Number of criteria for alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - V
Periodo de tiempo: 24 months post-randomization
24 months post-randomization
Number of days absent from work due to illness
Periodo de tiempo: 3 months post-randomization
3 months post-randomization
Number of days absent from work due to illness
Periodo de tiempo: 6 months post-randomization
6 months post-randomization
Number of days absent from work due to illness
Periodo de tiempo: 12 months post-randomization
12 months post-randomization
Number of days absent from work due to illness
Periodo de tiempo: 24 months post-randomization
24 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Periodo de tiempo: 3 months post-randomization
3 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Periodo de tiempo: 6 months post-randomization
6 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Periodo de tiempo: 12 months post-randomization
12 months post-randomization
Score on Montgomery-Åsberg Depression Rating Scale
Periodo de tiempo: 24 months post-randomization
24 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Periodo de tiempo: 3 months post-randomization
3 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Periodo de tiempo: 6 months post-randomization
6 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Periodo de tiempo: 12 months post-randomization
12 months post-randomization
Score on Generalised Anxiety Disorder 7-item scale
Periodo de tiempo: 24 months post-randomization
24 months post-randomization
Score on EQ-5D measuring the quality of life
Periodo de tiempo: 3 months post-randomization
3 months post-randomization
Score on EQ-5D measuring the quality of life
Periodo de tiempo: 6 months post-randomization
6 months post-randomization
Score on EQ-5D measuring the quality of life
Periodo de tiempo: 12 months post-randomization
12 months post-randomization
Score on EQ-5D measuring the quality of life
Periodo de tiempo: 24 months post-randomization
24 months post-randomization
Cost for treatment
Periodo de tiempo: 3 months post-randomization
3 months post-randomization
Cost for treatment
Periodo de tiempo: 6 months post-randomization
6 months post-randomization
Cost for treatment
Periodo de tiempo: 12 months post-randomization
12 months post-randomization
Cost for treatment
Periodo de tiempo: 24 months post-randomization
24 months post-randomization

Colaboradores e Investigadores

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

Patrocinador

Karolinska Institutet

Colaboradores

Region Stockholm

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 noviembre de 2015

Finalización primaria (Anticipado)

1 de diciembre de 2019

Finalización del estudio (Anticipado)

1 de diciembre de 2019

Fechas de registro del estudio

Enviado por primera vez

11 de enero de 2016

Primero enviado que cumplió con los criterios de control de calidad

1 de febrero de 2016

Publicado por primera vez (Estimar)

2 de febrero de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de mayo de 2019

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

29 de mayo de 2019

Última verificación

1 de mayo de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2014/1758-31/2

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. .

Ensayos clínicos sobre Trastornos por consumo de alcohol

Ensayos clínicos sobre Guide to better alcohol habits

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Ethiopia

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

Suscribir