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Active, Not Recruiting

NCT Number: NCT04535258

Blended Treatment for Alcohol Use Disorder

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit if Clinical Alcohol Research

Odense, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None.

Treatment and study plan

Blend-A

Device

Treatment for alcohol use disorders will be offered also as an internet-based option.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Region of Southern Denmark

Registry information

Official study title

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

Acronym: BLEND-A

Important dates

Study start
2020
Primary completion
2022
Study completion
2027
First posted
Sep 1, 2020
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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