Validation of a Training Program for Patients With Alcohol Use Disorder

Validation of a Computer-based Training Program for Patients With Alcohol Use Disorder

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Behavioral: TAU; Behavioral: SALIENCE

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 Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Mannheim, Baden-Württemberg, Germany, 68159
      • Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TAU; treatment as usual	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.
Experimental: TAU plus SALIENCE; treatment as usual plus computer-based intervention "SALIENCE"	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.; Behavioral: SALIENCE; 3 computer-based training sessions with program "SALIENCE" per week over 3 weeks (see study description)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse	time to first severe relapse	90 days after study inclusion

Collaborators and Investigators

• Sponsor: Central Institute of Mental Health, Mannheim
• Investigators: Principal Investigator: Sabine Vollstädt-Klein, ZI Mannheim

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism
• Other Study ID Numbers: SALIENCE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No