The Self Match Study: A Study of Informed Choice in the Treatment of Addiction

Not Applicable

Completed

• Conditions: Alcohol Dependence
• Interventions: Behavioral: Self Match; Behavioral: Expert Match

• Registration Number: NCT03278821
• Lead Sponsor: Kjeld Andersen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-29
• Study Start: 2017-05-01
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Primary Completion: 2019-11-01
• Study Completion: 2021-01-29
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-26
• Last Update Posted: 2021-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self Match	Self Match	The patient must choose between the five possible treatment options.
Expert Match	Expert Match	The Patient is referred to treatment by standard procedure which is Expert Match based on patient data.

Primary Outcome Measures

Name	Time	Method
Reduced amount of drinking days measured by Time Line Follow Back.	6 months after initiation of treatment.	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life measured by WHO's Quality of Life scale.	6 months after treatment start.	Patients reporting increase or decrease in quality of life compared to baseline.
Deviation in the chosen treatment in the Self-Match group in relation to the expected expert choice.	6 months after treatment start.	The algorithm score used in expert-matching will be calculated for all patients. The chosen treatment for patients in The Self-Match Group will be compared to the algorithm score to measure convergence between Self-Match and Expert-Match.
Compliance measured by proportion of patients who has completed treatment.	6 months after treatment start	Data on patients who have completed treatment as planned will be gathered from treatment journal.
Personality traits, measured by NEO-FFI-3, influence on outcome.	6 months after treatment start.	Comparison of personality traits with outcome measures.

Trial Locations

Locations (1)

RESCueH alcohol Studies, Unit of Clinical Alcohol Research, Psyciatric Research Unit, Clinical Institute, University of Southern Denmark; 🇩🇰 Odense, Denmark