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NCT Number: NCT03278821

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

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.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Odense, DK - 5000 C, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

-

Treatment and study plan

Self Match

Behavioral

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

Expert Match

Behavioral

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 6 months after treatment start

    Data on patients who have completed treatment as planned will be gathered from treatment journal.

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

    Time frame: 6 months after treatment start.

    Patients reporting increase or decrease in quality of life compared to baseline.

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

    Time frame: 6 months after treatment start.

    Comparison of personality traits with outcome measures.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kjeld Andersen

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Sep 12, 2017
Registry last updated
Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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