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Active Not RecruitingNCT03765476

Validation of a Training Program for Patients With Alcohol Use Disorder

Validation of a Computer-based Training Program for Patients With Alcohol Use Disorder

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
125 (estimated)
Sponsor
Central Institute of Mental Health, Mannheim · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

This study aims to detect how the Web-based program SALIENCE affects patients with alcohol-use Disorder in terms of craving, cognitive functions and risk of relapse.

Detailed description

In the web-based program SALIENCE ("Stop Alcohol In Everyday life - New Choices and Evaluations") the patient has to make decisions for non-alcoholic and against alcoholic drinks. Therefore there are several scenarios, which are supposed to let the patient integrate these choices into a realistic, everyday life, setting and help the patient to maintain abstinence in upcoming "high risk situations". It has been developed as an add-on therapy to increase the overall outcome. Participating patients with alcohol-use disorder are to receive an initial screening including questionnaires and neuropsychological tests. Then the patients receive three training sessions with SALIENCE each week. After three weeks there is another examination. After these three weeks, there is a 90 day period in which there are online follow-ups every two weeks to assess the craving and relapse of the participants. After the 90 day period there is a third examination analog to the first and the second one. For the first 25 subjects, the follow-up and T3 will be omitted; for this collective, an interim evaluation will be performed after T2 as a pilot study, followed by optimization of the protocol if necessary. The first 25 subjects will all receive SALIENCE; a comparison with standard therapy is not planned for this collective. There will be 2 weeks between T1 and T2 in the pilot study.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSALIENCE3 computer-based training sessions with program "SALIENCE" per week over 3 weeks (see study description)
BEHAVIORALTAUtreatment as usual, , i.e. medically supervised detoxification treatment (i.e. medical management of withdrawal symptoms, associated physical discomfort and any co-existing disorders, etc.) as well as health education and supportive therapy sessions.

Timeline

Start date
2018-07-01
Primary completion
2026-12-31
Completion
2026-12-31
First posted
2018-12-05
Last updated
2025-04-29

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03765476. Inclusion in this directory is not an endorsement.