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

A Randomized Controlled Study of Patients Matching Themselves to Treatment Options: The Self-Match Study

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Dependence
• Intervention / Treatment: Behavioral: Self Match; Behavioral: Expert Match

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, DK - 5000 C
    • RESCueH alcohol Studies, Unit of Clinical Alcohol Research, Psyciatric Research Unit, Clinical Institute, University of Southern Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self Match; The patient must choose between the five possible treatment options.	Behavioral: Self Match; Video presentation of treatment option are shown to the patient whereafter the patient must choose between the five possible treatment options.
Active Comparator: Expert Match; The Patient is referred to treatment by standard procedure which is Expert Match based on patient data.	Behavioral: Expert Match; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance measured by proportion of patients who has completed treatment.	Data on patients who have completed treatment as planned will be gathered from treatment journal.	6 months after treatment start
Quality of life measured by WHO's Quality of Life scale.	Patients reporting increase or decrease in quality of life compared to baseline.	6 months after treatment start.
Personality traits, measured by NEO-FFI-3, influence on outcome.	Comparison of personality traits with outcome measures.	6 months after treatment start.
Deviation in the chosen treatment in the Self-Match group in relation to the expected expert choice.	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.	6 months after treatment start.

Collaborators and Investigators

• Sponsor: Kjeld Andersen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): January 29, 2021

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Alcohol use disorder; Addiction treatment; Informed choice
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: RESCueH, The Self Match Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No