Validation of a Training Program for Patients With Alcohol Use Disorder

• Sponsor: Central Institute of Mental Health, Mannheim (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03765476
• Collaborator: (none)
• Enrollment: 125
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 54
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder	Behavioral: SALIENCE; Behavioral: TAU	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: one group receives add-on- intervention "SALIENCE"one group receives add-on- intervention "SALIENCE"
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Validation of a Computer-based Training Program for Patients With Alcohol Use Disorder
• Actual Study Start Date: Jul 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in alcohol craving [directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)]

   Visual Analogue Scale

2. Change in attentional bias [directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)]

   Dotprobe-Task (MacLeod, Mathews, & Tata, 1986)

3. Change in alcohol interference [directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)]

   Alcohol Stroop Test (Brand, Leichsenring-Driessen, Beblo, Kremer, & Driessen, 2009)

4. Change in approach-avoidance tendencies [directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)]

   Approach Avoidance Task (AAT) (R. W. Wiers et al., 2009)

Secondary Outcome Measures

1. Relapse [90 days after study inclusion]

   time to first severe relapse

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit	Mannheim	Baden-Württemberg	Germany	68159

Sponsors and Collaborators

• Central Institute of Mental Health, Mannheim

Investigators

• Principal Investigator: Sabine Vollstädt-Klein, ZI Mannheim

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Central Institute of Mental Health, Mannheim
• ClinicalTrials.gov Identifier: NCT03765476
• Other Study ID Numbers: SALIENCE
• First Posted: Dec 5, 2018
• Last Update Posted: Apr 22, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alcoholism; Alcohol Drinking

Study Results

No Results Posted as of Apr 22, 2021