Trials / Active Not Recruiting
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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | SALIENCE | 3 computer-based training sessions with program "SALIENCE" per week over 3 weeks (see study description) |
| BEHAVIORAL | TAU | treatment 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.