Validation of a Training Program for Patients With Alcohol Use Disorder

NCT03765476 | Active Not Recruiting

• 1 other identifier: SALIENCE
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (1)

• Relapse

  90 days after study inclusion

Study Arms (2)

TAU

ACTIVE COMPARATOR

treatment as usual

Behavioral: TAU

TAU plus SALIENCE

EXPERIMENTAL

treatment as usual plus computer-based intervention "SALIENCE"

Behavioral: SALIENCE; Behavioral: TAU

Interventions

SALIENCE BEHAVIORAL

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

TAU plus SALIENCE

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.

TAU; TAU plus SALIENCE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

You may not qualify if:

• 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)

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead

Study Sites (1)

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

Related Publications (1)

• 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.

  PMID: 37934561 DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Sabine Vollstädt-Klein

  ZI Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: one group receives add-on- intervention "SALIENCE"

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: December 5, 2018
• Study Start: July 1, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

DE (1)