Validation of a Training Program for Patients With Alcohol Use Disorder

Not Applicable

Active, not recruiting

• Conditions: Alcohol Use Disorder
• Interventions: Behavioral: SALIENCE; Behavioral: TAU

• Registration Number: NCT03765476
• Lead Sponsor: Central Institute of Mental Health, Mannheim

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.

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 125

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU plus SALIENCE	TAU	treatment as usual plus computer-based intervention "SALIENCE"
TAU	TAU	treatment as usual
TAU plus SALIENCE	SALIENCE	treatment as usual plus computer-based intervention "SALIENCE"

Primary Outcome Measures

Name	Time	Method
Change in alcohol interference	directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)	Alcohol Stroop Test (Brand, Leichsenring-Driessen, Beblo, Kremer, \& Driessen, 2009)
Change in attentional bias	directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)	Dotprobe-Task (MacLeod, Mathews, \& Tata, 1986)
Change in approach-avoidance tendencies	directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)	Approach Avoidance Task (AAT) (R. W. Wiers et al., 2009)
Change in alcohol craving	directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)	Visual Analogue Scale

Secondary Outcome Measures

Name	Time	Method
Relapse	90 days after study inclusion	time to first severe relapse

Trial Locations

Locations (1)

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit; 🇩🇪 Mannheim, Baden-Württemberg, Germany