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Blended Treatment for Alcohol Use Disorder (BLEND-A)

9 de septiembre de 2022 actualizado por: University of Southern Denmark

Blended Treatment for Alcohol Use Disorder - The BLEND-A Study Evaluation of a Blended Treatment Intervention for Alcohol Use Disorder in Denmark

Blended Treatment for Alcohol Use Disorder (BLEND-A) is a pragmatic, cluster randomized controlled trial to assess the clinical effectiveness and cost-effectiveness of implementing a blended treatment format that aims to reduce problematic alcohol use. Blended treatment is a treatment format where treatment as usual is offered as a combination of online and face-to-face sessions, integrated into one treatment protocol. The BLEND-A study will evaluate and implement a blended treatment program in routine alcohol addiction treatment. The trial is led by Unit of Clinical Alcohol Research, University of Southern Denmark (UCAR) in collaboration with partners at the Centre for Telepsychiatry in the Region of Southern Denmark (CTP), and Sundhed.dk.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Background: A major challenge to psychological treatment for Alcohol Use Disorder (AUD) is patient non-compliance. A promising new treatment approach that is hypothesized to increase treatment compliance is blended treatment, consisting of face-to-face contact with a therapist combined with modules delivered over the Internet within the same protocol. While this treatment concept has been developed and proven effective for a variety of mental disorders, it has not yet been examined for AUD.

Aims: The study described in this protocol aims to examine and evaluate patient compliance with blended AUD treatment as well as the clinical and cost effectiveness of such treatment compared to face-to-face treatment only.

Methods: The study design is a pragmatic, stepped-wedge cluster randomized controlled trial. The included outpatient institutions (planned number of patients: n=1800) will be randomized in clusters to implement either blended AUD treatment or face-to-face treatment only, i.e. treatment as usual (TAU). Both treatment approaches consist of motivational interviewing and cognitive behavioral therapy. Data on socio-demographics, alcohol consumption, addiction severity, treatment retention, treatment duration and intensity, and type of conclusion of treatment (dropout vs. compliance), will be retrieved from the National Register of Alcohol Treatment (NAB). In addition, all patients will be assessed for alcohol consumption, consequences of drinking and quality of life at treatment entry and six months after treatment conclusion. Data will be analyzed with an Intention-to-treat approach by means of generalized mixed models with random effect for cluster and fixed effect for each step. Also, analyses evaluating cost-effectiveness will be conducted.

Discussion: Blended treatment may increase treatment compliance and thus improve treatment outcomes due to increased flexibility of the treatment course. Since this study is conducted within an implementation framework it can easily be scaled up, and blended treatment has the potential to become an alternative offer in the majority ofmany outpatient clinics nationwide.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

1800

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

  • Dinamarca
      • Odense, Dinamarca, 5000
        • Unit if Clinical Alcohol Research

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:

  • Legal person seeking public alcohol treatment in the participating municipalities.

Exclusion Criteria:

  • None.

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 cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: First-movers
The first four alcohol clinics offers internet-based treatment to the patients who chooses the proportion of internet-based sessions.
Dispositivo: Blend-A
Treatment for alcohol use disorders will be offered also as an internet-based option.
Otro: Second-movers
After three months, the next five alcohol clinics offers internet-based treatment to the patients who chooses the proportion of internet-based sessions.
Dispositivo: Blend-A
Treatment for alcohol use disorders will be offered also as an internet-based option.
Otro: Third-movers
After three months, the next five alcohol clinics offers internet-based treatment to the patients who chooses the proportion of internet-based sessions.
Dispositivo: Blend-A
Treatment for alcohol use disorders will be offered also as an internet-based option.
Otro: Fourth-movers
After three months, the last four alcohol clinics offers internet-based treatment to the patients who chooses the proportion of internet-based sessions.
Dispositivo: Blend-A
Treatment for alcohol use disorders will be offered also as an internet-based option.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Compliance and premature dropout in alcohol treatment
Periodo de tiempo: One year after enrolled in the study
BLEND-A (outpatient treatment as usual offered as a combination between face-to face and internet-based sessions) leads to a change in compliance in treatment during one year following initiation of treatment, compared to TAU (usual treatment delivered as face-to-face outpatient treatment only ), and measured as a change in premature dropout of treatment in the National Register of alcohol treatment (NAB).
One year after enrolled in the study
Effectiveness of alcohol treatment
Periodo de tiempo: 6 months after enrolled in the study
The effectiveness of BLEND-A compared to TAU, measured by alcohol intake 6 months after treatment start. The alcohol intake is measured by self-reported alcohol intake.
6 months after enrolled in the study

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Differences in Quality of Life according to the intervention
Periodo de tiempo: 6 months after enrolled in the study
BLEND-A leads to a change in quality of life (measured by means of Patient Reported Outcomes (PRO)) among patients, compared to face-to-face outpatient treatment as usual, measured 6 months after treatment start.
6 months after enrolled in the study
Which part of treatment is appreciated to receive via the internet
Periodo de tiempo: Through study completion, an average of 1 year
Based on the user data from BLEND-A, we expect to be able to determine what part of the usual treatment that is appreciated to receive via the internet.
Through study completion, an average of 1 year
Optimal blend
Periodo de tiempo: Through study completion, an average of 1 year
Based on the user data from BLEND-A, we expect to be able to determine the optimal combination of face-to-face and internet-based sessions.
Through study completion, an average of 1 year

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Qualitative interviews
Periodo de tiempo: Through study completion, an average of 1 year
The perspectives for further refinement of BLEND-A will be assessed by qualitative interviews with patients and therapists receiving or delivering the intervention.
Through study completion, an average of 1 year

Colaboradores e Investigadores

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

Patrocinador

University of Southern Denmark

Colaboradores

Region of Southern Denmark

Investigadores

  • Director de estudio: Anette S. Nielsen, PhD, University of Southern Denmark

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

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)

1 de junio de 2020

Finalización primaria (Actual)

30 de junio de 2022

Finalización del estudio (Anticipado)

31 de diciembre de 2023

Fechas de registro del estudio

Enviado por primera vez

24 de abril de 2020

Primero enviado que cumplió con los criterios de control de calidad

31 de agosto de 2020

Publicado por primera vez (Actual)

1 de septiembre de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2022

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

9 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

  • BLEND-A

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

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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