Validation of a Training Program for Patients With Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03765476
• Other study ID #: SALIENCE
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 125
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

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

Locations

Country	Name	City	State
Germany	Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit	Mannheim	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in alcohol craving	Visual Analogue Scale	directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
Primary	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)
Primary	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)
Primary	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	Relapse	time to first severe relapse	90 days after study inclusion