Validation of a Training Program for Patients With Alcohol Use Disorder

NCT ID: NCT03765476

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2026-12-31

Brief 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

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAU

treatment as usual

Group Type: ACTIVE_COMPARATOR

TAU

Intervention Type: 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.

TAU plus SALIENCE

treatment as usual plus computer-based intervention "SALIENCE"

Group Type: EXPERIMENTAL

SALIENCE

Intervention Type: BEHAVIORAL

3 computer-based training sessions with program "SALIENCE" per week over 3 weeks (see study description)

TAU

Intervention Type: 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.

Interventions

SALIENCE

3 computer-based training sessions with program "SALIENCE" per week over 3 weeks (see study description)

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• age between 18 and 65
• alcohol use disorder (DSM-5)
• inpatient or part inpatient treatment
• alcohol abstinence for at least 72 hours and maximum for three weeks
• normal or correctable eyesight
• Sufficient ability to communicate with the investigators, to answer questions in oral and written form
• "Fully Informed Consent"
• "Written Informed Consent"

Exclusion Criteria

• Withdrawal of the declaration of consent
• severe internistic, neurological or psychiatric comorbidities
• severe withdrawal symptoms (CIWA-R > 7)
• alcohol-intoxication (> 0 ‰)
• Pharmacotherapy with psychoactive substances within the last 14 days (except Clomethiazole or Benzodiazepines within the alcohol withdrawal treatment; treatment with these medications has to be completed within last 3 days)
• Axis 1 disorder according to ICD-10 and DSM 5 (except tobacco use disorder and specific phobia within the last 12 months)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sabine Vollstädt-Klein

Role: PRINCIPAL_INVESTIGATOR

ZI Mannheim

Locations

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Baden-Wurttemberg, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 37934561 (View on PubMed)

Other Identifiers

SALIENCE

Identifier Type: -

Identifier Source: org_study_id