Validation of a Training Program for Patients With Alcohol Use Disorder

Central Institute of Mental Health, Mannheim

Status: Active, not recruiting

Conditions: Alcohol Use Disorder

Treatments: Behavioral: TAU; Behavioral: SALIENCE

Study type: Interventional

Funder types: Other

Identifiers

NCT03765476

SALIENCE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 2 patient groups

TAU

Active Comparator group

Description:

treatment as usual

Treatment:

Behavioral: TAU

TAU plus SALIENCE

Experimental group

Description:

treatment as usual plus computer-based intervention "SALIENCE"

Treatment:

Behavioral: SALIENCE

Behavioral: TAU