Clinical trial NCT03765476: Validation of a Training Program for Patients With Alcohol Use Disorder
Official title: Validation of a Computer-based Training Program for Patients With Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one group receives add-on- intervention "SALIENCE"
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in alcohol craving
timeFrame: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
measure: Change in attentional bias
timeFrame: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
measure: Change in alcohol interference
timeFrame: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
measure: Change in approach-avoidance tendencies
timeFrame: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
Secondary outcomes:
measure: Relapse
timeFrame: 90 days after study inclusion
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
state: Baden-Württemberg
Study officials:
affiliation: ZI Mannheim
name: Sabine Vollstädt-Klein
role: PRINCIPAL_INVESTIGATOR
References: