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CompletedNCT03278821Updated Oct 27, 2021

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

An interventional study of Self Match and Expert Match in Alcohol Dependence, sponsored by Kjeld Andersen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-27.

Sponsored by Kjeld Andersen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Alcohol Dependence

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Keywords

  • Informed choice
  • Alcohol use disorder
  • Addiction treatment
03

In context

Alcoholism

1,634 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 400 is above the median of 88 across 1,395 interventional studies indexed under Alcoholism.

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Lead sponsor

Kjeld Andersen is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

-

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
400 participants (actual)

Study arms

  • Experimental
    Self Match

    The patient must choose between the five possible treatment options.

    Behavioral: Self Match

  • Active comparator
    Expert Match

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

    Behavioral: Expert Match

Interventions

  • BehavioralSelf Match

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

  • BehavioralExpert 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.

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What researchers measure

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.

    Time frame: 6 months after initiation of treatment.

Secondary outcomes

  1. 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.

    Time frame: 6 months after treatment start

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

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

    Time frame: 6 months after treatment start.

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

    Comparison of personality traits with outcome measures.

    Time frame: 6 months after treatment start.

  4. 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.

    Time frame: 6 months after treatment start.

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Study locations

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

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. PubMed 29625579 ↗

Study documents

  • Statistical analysis plan · Dec 4, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03278821
Lead sponsor
Kjeld Andersen
Responsible party
Kjeld Andersen (Professor, University of Southern Denmark) — Sponsor-investigator
First posted
Sep 12, 2017
Start date
May 1, 2017
Primary completion
Nov 1, 2019
Completion
Jan 29, 2021
Last update
Oct 27, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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