NCT04822987

Brief Summary

Harmful alcohol use is a global risk factor for disease, injuries and death. Research on treatment of Alcohol use disorders (AUDs) indicates that different treatment modalities are equally effective, but also that a large group of patients do not change their drinking pattern despite being in treatment. It is assumed that it is not random who benefits from treatment. Thirty to forty percent of outcome variance in treatment is probably explained by patient factors, and we need more knowledge on how different patient factors moderate treatment effects. Further, clinicians also need more knowledge about selecting patients to different therapies. The present study will investigate how patient factors predict outcome in group treatment of AUDs, and what predicts positive treatment outcomes over time. The study is designed as a quasi-experimental, multi-centre, follow-up study. Patients will be included from Vestfold Hospital Trust, Borgestadklinikken, Blue Cross Clinic, Behandlingssenteret Eina, Blue Cross Clinic and A-senteret, Oslo, Church City Mission. The Project will provide more knowledge about patients seeking treatment for AUDs, and specifically how patient factors predict outcome in group treatment. These results will in turn lead to better selection of treatment modalities, and patients will receive a more effective treatment earlier on. Main aims: 1) How do patient factors predict outcome in group treatment of alcohol use disorders (AUDs)? 2) Do positive treatment outcomes last over time? Specifically, do the following factors: a) psychiatric comorbidity b) severity of alcohol use pre-treatment c) personality disorders and d) cognitive impairments predict 1) completion of group treatment and 2) positive outcome after 1 year. As an additional aim, we will investigate if the Montreal Cognitive Assessment test (MoCa) is feasible as a brief screening instrument for mild cognitive impairments for AUD patients.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
57mo left

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

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 Progress53%
Feb 2021Dec 2030

Study Start

First participant enrolled

February 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

4.9 years

First QC Date

March 16, 2021

Last Update Submit

September 8, 2025

Conditions

Keywords

outcome predictorsnaturalistic studyfollow up studygroup treatment

Outcome Measures

Primary Outcomes (3)

  • Successful treatment completion

    Operationalized as percentage of participation in therapeutic activities

    At treatment completion assessed up to 14 days

  • Change in alcohol consumption

    Change in alcohol consumption after 1 year. Measured with Alcohol use disorders identification test (AUDIT) and one additional question of number of alcohol units consumed during the last week.

    Assessed 1 year after treatment completion

  • Change in alcohol consumption

    Change in alcohol consumption after 3 years. Measured with Alcohol use disorders identification test (AUDIT), and one additional question of number of alcohol units consumed during the last week.

    Assessed 3 years after treatment completion

Secondary Outcomes (5)

  • Change in psychological symptom level

    1 year after treatment completion

  • Change in psychological symptom level

    3 years after treatment completion

  • Participation in working life and use of health services

    Assessed 3 years after treatment completion

  • Predictors for successful outcome of group therapy

    1 year after treatment completion

  • Is Montreal Cognitive Assessment (MoCa) feasible as a brief screening instrument for mild cognitive impairments in patients with Alcohol use disorders (AUDs)

    3 years after study start, when recruitment is completed

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients between 18 and 90 years enrolled in treatment at one of the study sites, and who participates in group treatment. Inclusion criteria is a primary diagnosis of alcohol use disorders. Patients with comorbid psychiatric, illegal drug use, personality and cognitive deficits problems are not excluded from the study.

You may qualify if:

  • Primary alcohol use disorder-diagnosis
  • Enrolled in treatment at one of the study sites
  • Participation in group therapy

You may not qualify if:

  • \- Lack of primary AUD-diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Blå kors behandlingssenter Eina

Eina, Oppland, 2843, Norway

Location

Borgestadklinikken

Skien, Vestfold Og Telemark, 3717, Norway

Location

Vestfold Hospital Trust

Tønsberg, Vestfold Og Telemark, 3117, Norway

Location

A-senteret

Oslo, 0469, Norway

Location

Related Publications (1)

  • Hoiland K, Arnevik EKA, Diep LM, Mathisen T, Witkiewitz K, Egeland J. Keep on Keeping on? Patient Factors Predicting Discontinuation in Alcohol Use Disorder Treatment. Subst Use Misuse. 2025;60(12):1808-1819. doi: 10.1080/10826084.2025.2519404. Epub 2025 Jun 24.

MeSH Terms

Conditions

AlcoholismSubstance-Related DisordersMental DisordersPersonality DisordersCognition DisordersCognitive Dysfunction

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersNeurocognitive Disorders

Study Officials

  • Jens Egeland, Phd

    Vestfold Hospital Trust/University of Oslo

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 30, 2021

Study Start

February 1, 2021

Primary Completion

January 1, 2026

Study Completion (Estimated)

December 31, 2030

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations