NCT04535258

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jun 2020Dec 2027

First Submitted

Initial submission to the registry

April 24, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

April 24, 2020

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Compliance and premature dropout in alcohol treatment

    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

    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 Outcomes (3)

  • Differences in Quality of Life according to the intervention

    6 months after enrolled in the study

  • Which part of treatment is appreciated to receive via the internet

    Through study completion, an average of 1 year

  • Optimal blend

    Through study completion, an average of 1 year

Other Outcomes (1)

  • Qualitative interviews

    Through study completion, an average of 1 year

Study Arms (4)

First-movers

OTHER

The first four alcohol clinics offers internet-based treatment to the patients who chooses the proportion of internet-based sessions.

Device: Blend-A

Second-movers

OTHER

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

Third-movers

OTHER

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

Fourth-movers

OTHER

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

Interventions

Blend-ADEVICE

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

First-moversFourth-moversSecond-moversThird-movers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit if Clinical Alcohol Research

Odense, 5000, Denmark

Location

Related Publications (2)

  • Tarp K, Christiansen R, Bilberg R, Borkner S, Dalsgaard C, Paldam Folker M, Sogaard Nielsen A. Patient Perspectives on Blended Internet-Based and Face-to-Face Cognitive Behavioral Therapy for Alcohol Use Disorder: Qualitative Study. J Med Internet Res. 2024 Oct 23;26:e47083. doi: 10.2196/47083.

  • Mellentin AI, Behrendt S, Bilberg R, Blankers M, Folker MP, Tarp K, Uffelmann J, Nielsen AS. BLEND-A: blending internet treatment into conventional face-to-face treatment for alcohol use disorder - a study protocol. BMC Psychiatry. 2021 Mar 6;21(1):131. doi: 10.1186/s12888-021-03122-4.

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Anette S. Nielsen, PhD

    University of Southern Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Stepped-wedge cluster randomized (18 institutions, 4 waves)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2020

First Posted

September 1, 2020

Study Start

June 1, 2020

Primary Completion

June 30, 2022

Study Completion (Estimated)

December 31, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations