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Clinical Trials/NCT03278821
NCT03278821CompletedNot Applicable

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

Kjeld Andersen1 site in 1 country400 target enrollmentStarted: May 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
400
Locations
1
Primary Endpoint
Reduced amount of drinking days measured by Time Line Follow Back.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Care Provider)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • Not provided

Arms & Interventions

Expert Match

Active Comparator

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

Intervention: Expert Match (Behavioral)

Self Match

Experimental

The patient must choose between the five possible treatment options.

Intervention: Self Match (Behavioral)

Outcomes

Primary Outcomes

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

  • Quality of life measured by WHO's Quality of Life scale.(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.)
  • Compliance measured by proportion of patients who has completed treatment.(6 months after treatment start)
  • Personality traits, measured by NEO-FFI-3, influence on outcome.(6 months after treatment start.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Kjeld Andersen

Professor

University of Southern Denmark

Study Sites (1)

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