Alcohol DependenceNCT03278821
The Self Match Study: A Study of Informed Choice in the Treatment of Addiction
A study testing Self Match and Expert Match in people with Alcohol Dependence, run by Kjeld Andersen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Self Match and Expert Match
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2017to 29 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
RESCueH alcohol Studies, Unit of Clinical Alcohol Research, Psyciatric Research Unit, Clinical Institute, University of Southern Denmark
Odense, DK - 5000 C
About this study
Official title: A Randomized Controlled Study of Patients Matching Themselves to Treatment Options: The Self-Match Study
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.
- Conditions
- Alcohol Dependence
- Being tested
- Self Match, Expert Match
- Keywords
- Informed choice, Alcohol use disorder, Addiction treatment
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self MatchBehavioural
Video presentation of treatment option are shown to the patient whereafter the patient must choose between the five possible treatment options.
Expert MatchBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self Match | Experimental | The patient must choose between the five possible treatment options. Receives: Behavioral: Self Match |
| Expert Match | Active comparator | The Patient is referred to treatment by standard procedure which is Expert Match based on patient data. Receives: Behavioral: Expert Match |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after initiation of treatment.
Secondary outcomes (4)
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.
Measured: 6 months after treatment start
Quality of life measured by WHO's Quality of Life scale.
Patients reporting increase or decrease in quality of life compared to baseline.
Measured: 6 months after treatment start.
Personality traits, measured by NEO-FFI-3, influence on outcome.
Comparison of personality traits with outcome measures.
Measured: 6 months after treatment start.
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.
Measured: 6 months after treatment start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 May 2017
- Primary completion1 Nov 2019
- Study completion29 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kjeld Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kjeld Andersen, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278821
- Sponsor's protocol ID
- RESCueH, The Self Match Study
- Status last verified
- Oct 2021
- First submitted
- 29 Mar 2017
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Patients Matching Themselves to Treatment Options: The Self-Match Study
- ClinicalTrials.gov ID
- NCT03278821
- Acronym / sponsor ID
- RESCueH, The Self Match Study
- Conditions
- Alcohol Dependence
- Keywords
- Informed choice, Alcohol use disorder, Addiction treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Kjeld AndersenUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self Match | Experimental | Behavioral: Self MatchThe patient must choose between the five possible treatment options. |
| Expert Match | Active comparator | Behavioral: Expert MatchThe Patient is referred to treatment by standard procedure which is Expert Match based on patient data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self MatchVideo presentation of treatment option are shown to the patient whereafter the patient must choose between the five possible treatment options. | Behavioural | Self Match |
| Expert MatchReferral 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. | Behavioural | Expert Match |
Primary outcome
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.
4 secondary outcomes
Compliance measured by proportion of patients who has completed treatment.
Time frame: 6 months after treatment start
Quality of life measured by WHO's Quality of Life scale.
Time frame: 6 months after treatment start.
Personality traits, measured by NEO-FFI-3, influence on outcome.
Time frame: 6 months after treatment start.
Deviation in the chosen treatment in the Self-Match group in relation to the expected expert choice.
Time frame: 6 months after treatment start.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Derived from this study: PubMed 29625579Hell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Match and Expert Match in people with Alcohol Dependence, run by Kjeld Andersen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced amount of drinking days measured by Time Line Follow Back. (time frame: 6 months after initiation of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03278821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021; AzTrials last refreshed its copy on 29 Oct 2026.