The Self Match Study: A Study of Informed Choice in the Treatment of Addiction
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Self Match
Expert Match
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring Informed choice, Alcohol use disorder, Addiction treatment
Eligibility Criteria
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:
-
Sites / Locations
- RESCueH alcohol Studies, Unit of Clinical Alcohol Research, Psyciatric Research Unit, Clinical Institute, University of Southern Denmark
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Self Match
Expert Match
Arm Description
The patient must choose between the five possible treatment options.
The Patient is referred to treatment by standard procedure which is Expert Match based on patient data.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Quality of life measured by WHO's Quality of Life scale.
Patients reporting increase or decrease in quality of life compared to baseline.
Personality traits, measured by NEO-FFI-3, influence on outcome.
Comparison of personality traits with outcome measures.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03278821
Brief Title
The Self Match Study: A Study of Informed Choice in the Treatment of Addiction
Official Title
A Randomized Controlled Study of Patients Matching Themselves to Treatment Options: The Self-Match Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
January 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kjeld Andersen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Informed choice, Alcohol use disorder, Addiction treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self Match
Arm Type
Experimental
Arm Description
The patient must choose between the five possible treatment options.
Arm Title
Expert Match
Arm Type
Active Comparator
Arm Description
The Patient is referred to treatment by standard procedure which is Expert Match based on patient data.
Intervention Type
Behavioral
Intervention Name(s)
Self Match
Intervention Description
Video presentation of treatment option are shown to the patient whereafter the patient must choose between the five possible treatment options.
Intervention Type
Behavioral
Intervention Name(s)
Expert Match
Intervention Description
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 Outcome Measure Information:
Title
Reduced amount of drinking days measured by Time Line Follow Back.
Description
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 Outcome Measure Information:
Title
Compliance measured by proportion of patients who has completed treatment.
Description
Data on patients who have completed treatment as planned will be gathered from treatment journal.
Time Frame
6 months after treatment start
Title
Quality of life measured by WHO's Quality of Life scale.
Description
Patients reporting increase or decrease in quality of life compared to baseline.
Time Frame
6 months after treatment start.
Title
Personality traits, measured by NEO-FFI-3, influence on outcome.
Description
Comparison of personality traits with outcome measures.
Time Frame
6 months after treatment start.
Title
Deviation in the chosen treatment in the Self-Match group in relation to the expected expert choice.
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Facility Information:
Facility Name
RESCueH alcohol Studies, Unit of Clinical Alcohol Research, Psyciatric Research Unit, Clinical Institute, University of Southern Denmark
City
Odense
ZIP/Postal Code
DK - 5000 C
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29625579
Citation
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.
Results Reference
derived
Learn more about this trial
The Self Match Study: A Study of Informed Choice in the Treatment of Addiction
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