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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAU | Active Comparator | treatment as usual |
|
| TAU plus SALIENCE | Experimental | treatment as usual plus computer-based intervention "SALIENCE" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SALIENCE | Behavioral | 3 computer-based training sessions with program "SALIENCE" per week over 3 weeks (see study description) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in alcohol craving | Visual Analogue Scale | directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks) |
| Change in attentional bias | Dotprobe-Task (MacLeod, Mathews, & Tata, 1986) | directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks) |
| Change in alcohol interference | Alcohol Stroop Test (Brand, Leichsenring-Driessen, Beblo, Kremer, & Driessen, 2009) | directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks) |
| Change in approach-avoidance tendencies | Approach Avoidance Task (AAT) (R. W. Wiers et al., 2009) | directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse | time to first severe relapse | 90 days after study inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabine Vollstädt-Klein | ZI Mannheim | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit | Mannheim | Baden-Wurttemberg | 68159 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37934561 | Derived | Weber A, Shevchenko Y, Gerhardt S, Hoffmann S, Kiefer F, Vollstadt-Klein S. Effectiveness of Reducing Craving in Alcohol Use Disorder Using a Serious Game (SALIENCE): Randomized Controlled Trial. JMIR Form Res. 2023 Nov 7;7:e42194. doi: 10.2196/42194. |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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one group receives add-on- intervention "SALIENCE"
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| TAU | Behavioral | 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. |
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