NCT03278821

Brief Summary

The purpose of this study is to determine whether patient self-matching (as compared with treatment as usual by expert matching) improves quality of life, retention, and outcome for patients being treated for alcohol problems. There are at least two good reasons for offering patients a choice when the goal is a change in their behavior. The first is that patients are likely to know what treatment works best for them. Secondly, being allowed to choose between options may increase compliance in treatment. As a randomized controlled trial, this study will compare the efficacy of patient self-matching versus treatment-as-usual expert matching. The Self-Match Study is expected to increase knowledge on the importance of involving the alcohol dependent patient in choosing what treatment method is best for him/her instead of having experts to do that. The investigators expect to discover patient involvement as a way to improve compliance in treatment, hence preventing that patients drop out of treatment to early. If this hypothesis proves to be right, clinicians will have a viable strategy for matching treatment methods to patients, since the strategy does not demand further resources in the treatment system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 29, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2021

Completed
Last Updated

October 27, 2021

Status Verified

October 1, 2021

Enrollment Period

2.5 years

First QC Date

March 29, 2017

Last Update Submit

October 26, 2021

Conditions

Alcohol Dependence

Keywords

Informed choiceAlcohol use disorderAddiction treatment

Outcome Measures

Primary Outcomes (1)

  • Reduced amount of drinking days measured by Time Line Follow Back.

    The primary endpoint analysis will be a comparison of outcomes for patients assigned to the self-match group vs. expert-match group to determine whether self-matching yields more favorable outcome than expert matching, measured by the number of excessive drinking days.

    6 months after initiation of treatment.

Secondary Outcomes (4)

  • Compliance measured by proportion of patients who has completed treatment.

    6 months after treatment start

  • Quality of life measured by WHO's Quality of Life scale.

    6 months after treatment start.

  • Personality traits, measured by NEO-FFI-3, influence on outcome.

    6 months after treatment start.

  • Deviation in the chosen treatment in the Self-Match group in relation to the expected expert choice.

    6 months after treatment start.

Study Arms (2)

Self Match

EXPERIMENTAL

The patient must choose between the five possible treatment options.

Behavioral: Self Match

Expert Match

ACTIVE COMPARATOR

The Patient is referred to treatment by standard procedure which is Expert Match based on patient data.

Behavioral: Expert Match

Interventions

Self MatchBEHAVIORAL

Video presentation of treatment option are shown to the patient whereafter the patient must choose between the five possible treatment options.

Self Match
Expert MatchBEHAVIORAL

Referral as usual to one of five possible treatment options. The referral is based on baseline data from the patient and by the means of an algorithm, used in daily clinical praxis.

Expert Match

Eligibility Criteria

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

You may qualify if:

  • Fulfilling DSM-IV criteria for alcohol abuse or dependence.
  • Native Danish speaking.
  • Having no severe psychosis or cognitive impairment.
  • Accepting to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RESCueH alcohol Studies, Unit of Clinical Alcohol Research, Psyciatric Research Unit, Clinical Institute, University of Southern Denmark

Odense, DK - 5000 C, Denmark

Location

Related Publications (1)

  • Hell ME, Miller WR, Nielsen B, Nielsen AS. Is treatment outcome improved if patients match themselves to treatment options? Study protocol for a randomized controlled trial. Trials. 2018 Apr 6;19(1):219. doi: 10.1186/s13063-018-2592-9.

    PMID: 29625579DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 29, 2017

First Posted

September 12, 2017

Study Start

May 1, 2017

Primary Completion

November 1, 2019

Study Completion

January 29, 2021

Last Updated

October 27, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)