Blended Treatment for Alcohol Use Disorder (BLEND-A)

September 9, 2022 updated by: 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

1800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: First-movers
The first four alcohol clinics offers internet-based treatment to the patients who chooses the proportion of internet-based sessions.
Device: Blend-A
Treatment for alcohol use disorders will be offered also as an internet-based option.
Other: 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.
Device: Blend-A
Treatment for alcohol use disorders will be offered also as an internet-based option.
Other: 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.
Device: Blend-A
Treatment for alcohol use disorders will be offered also as an internet-based option.
Other: 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.
Device: Blend-A
Treatment for alcohol use disorders will be offered also as an internet-based option.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance and premature dropout in alcohol treatment
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in Quality of Life according to the intervention
Time Frame: 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
Time Frame: 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
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative interviews
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Region of Southern Denmark

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

June 30, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

August 31, 2020

First Posted (Actual)

September 1, 2020

Study Record Updates

Last Update Posted (Actual)

September 10, 2022

Last Update Submitted That Met QC Criteria

September 9, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BLEND-A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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