Validation of a Training Program for Patients With Alcohol Use Disorder
Primary Purpose
Alcohol Use Disorder
Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
SALIENCE
TAU
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
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)
Sites / Locations
- Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TAU
TAU plus SALIENCE
Arm Description
treatment as usual
treatment as usual plus computer-based intervention "SALIENCE"
Outcomes
Primary Outcome Measures
Change in alcohol craving
Visual Analogue Scale
Change in attentional bias
Dotprobe-Task (MacLeod, Mathews, & Tata, 1986)
Change in alcohol interference
Alcohol Stroop Test (Brand, Leichsenring-Driessen, Beblo, Kremer, & Driessen, 2009)
Change in approach-avoidance tendencies
Approach Avoidance Task (AAT) (R. W. Wiers et al., 2009)
Secondary Outcome Measures
Relapse
time to first severe relapse
Full Information
NCT ID
NCT03765476
First Posted
October 23, 2018
Last Updated
January 24, 2023
Sponsor
Central Institute of Mental Health, Mannheim
1. Study Identification
Unique Protocol Identification Number
NCT03765476
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Institute of Mental Health, Mannheim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
one group receives add-on- intervention "SALIENCE"
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
treatment as usual
Arm Title
TAU plus SALIENCE
Arm Type
Experimental
Arm Description
treatment as usual plus computer-based intervention "SALIENCE"
Intervention Type
Behavioral
Intervention Name(s)
SALIENCE
Intervention Description
3 computer-based training sessions with program "SALIENCE" per week over 3 weeks (see study description)
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in alcohol craving
Description
Visual Analogue Scale
Time Frame
directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
Title
Change in attentional bias
Description
Dotprobe-Task (MacLeod, Mathews, & Tata, 1986)
Time Frame
directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
Title
Change in alcohol interference
Description
Alcohol Stroop Test (Brand, Leichsenring-Driessen, Beblo, Kremer, & Driessen, 2009)
Time Frame
directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
Title
Change in approach-avoidance tendencies
Description
Approach Avoidance Task (AAT) (R. W. Wiers et al., 2009)
Time Frame
directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
Secondary Outcome Measure Information:
Title
Relapse
Description
time to first severe relapse
Time Frame
90 days after study inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Vollstädt-Klein
Organizational Affiliation
ZI Mannheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68159
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Validation of a Training Program for Patients With Alcohol Use Disorder
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