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

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ClinicalTrials.gov Identifier: NCT03278821
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Kjeld Andersen, University of Southern Denmark

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.


Condition or disease Intervention/treatment Phase
Alcohol Dependence Behavioral: Self Match Behavioral: Ekspert Match Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: The Self Match Study
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : January 29, 2021

Arm Intervention/treatment
Experimental: Self Match
The patient must choose between the five possible treatment options.
Behavioral: Self Match
Video presentation of treatment option are shown to the patient whereafter the patient must choose between the five possible treatment options.

Active Comparator: Expert Match
The Patient is referred to treatment by standard procedure which is Expert Match based on patient data.
Behavioral: Ekspert 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278821


Contacts
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Contact: Morten E Hell, msc +45 28864919 mhell@health.sdu.dk
Contact: Anette S Nielsen, phd ansnielsen@health.sdu.dk

Locations
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Denmark
RESCueH alcohol Studies, Unit of Clinical Alcohol Research, Psyciatric Research Unit, Clinical Institute, University of Southern Denmark Recruiting
Odense, Denmark, DK - 5000 C
Contact: Morten E Hell, Msc    +45 28864919    mhell@health.sdu.dk   
Contact: Anette S Nielsen, Ph.D.       ansnielsen@health.sdu.dk   
Sponsors and Collaborators
Kjeld Andersen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kjeld Andersen, Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03278821     History of Changes
Other Study ID Numbers: RESCueH, The Self Match Study
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kjeld Andersen, University of Southern Denmark:
Informed choice
Alcohol use disorder
Addiction treatment

Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders