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

Alcohol Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03278821
• Other study ID #: RESCueH, The Self Match Study
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: January 29, 2021

Study information

• Verified date: October 2021
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 29, 2021
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Behavioral:
• Self Match
Video presentation of treatment option are shown to the patient whereafter the patient must choose between the five possible treatment options.
• 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.

Locations

Country	Name	City	State
Denmark	RESCueH alcohol Studies, Unit of Clinical Alcohol Research, Psyciatric Research Unit, Clinical Institute, University of Southern Denmark	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Kjeld Andersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	Personality traits, measured by NEO-FFI-3, influence on outcome.	Comparison of personality traits with outcome measures.	6 months after treatment start.
Secondary	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.