Plain English Summary
Background and study aims
Problem drinking that becomes severe is given the medical diagnosis of “alcohol use disorder” or AUD. AUD is a chronic relapsing brain disorder characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences.
Alcohol-avoidance training using PC and joystick is a promising new add-on intervention for patients with AUD, helping them to avoid relapse. However, many patients also suffer from anxiety and mood disorders, and we don't know whether training also helps them.
Who can participate?
Alcohol-dependent in patients who are currently abstinent and receive treatment at a rehabilitation clinic
What does the study involve?
All patients receive 12 weeks of inpatient treatment as usual. On top of that, half of the patients complete 12 sessions of Alcohol-Avoidance Training. During training, patients use a joystick to push away pictures of alcoholic drinks and pull closer pictures of non-alcoholic drinks.
What are the possible benefits and risks of participating?
The possible benefit is a reduced risk of relapse. There are no risks.
Where is the study run from?
The study is run at the salus clinic Lindow, Germany.
When is the study starting and how long is it expected to run for?
January 2009 to December 2010
Who is funding the study?
The German Pension Fund (Deutsche Rentenversicherung Bund).
Who is the main contact?
Prof. Dr. Mike Rinck, m.rinck@psych.ru.nl
Trial website
Contact information
Type
Scientific
Primary contact
Prof Mike Rinck
ORCID ID
Contact details
PO Box 9104
Nijmegen
6500 HE
Netherlands
+31 243612154
m.rinck@psych.ru.nl
Type
Public
Additional contact
Prof Mike Rinck
ORCID ID
Contact details
PO Box 9104
Nijmegen
6500 HE
Netherlands
+31 243612154
m.rinck@psych.ru.nl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Affective comorbidity moderates the relapse-preventive effect of alcohol-related approach bias modification
Acronym
Study hypothesis
Active Alcohol-Avoidance Training reduces relapse rates in comorbid and non-comorbid, currently abstinent alcohol-dependent patients
Ethics approval
Approved (original date unknown, confirmed on 01/09/2020) Deutsche Rentenversicherung Berlin-Brandenburg (Knobelsdorffstr. 92, 14059 Berlin, Germany; +49 3030021601; ulrich.eggens@drv-berlinbrandenburg.de), ref: n/a
Study design
Single-center interventional blinded randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Alcohol dependence
Intervention
During their 3-months stay at a rehabilitation clinic, currently abstinent alcohol-dependent patients are randomly assigned to an active training group vs. a control group.
Active training condition: In addition to treatment-as-usual, patients complete 12 sessions of alcohol-avoidance training. During each session, they use a joystick and a PC to push away 100 pictures of alcoholic drinks and pull closer 100 pictures of non-alcoholic drinks.
Control condition: Treatment-as-usual only.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Relapse at 1-year follow-up measured by a standard questionnaire given on paper or via telephone
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
01/01/2009
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Alcohol-dependent, currently abstinent
2. Aged ≥ 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
720
Total final enrolment
729
Participant exclusion criteria
1. Non-native speaker of German
2. History of schizophrenia or psychotic disorders
3. Visual or hand-motoric handicaps
4. Strong withdrawal symptoms
5. Neuro-cognitive problems
Recruitment start date
28/09/2009
Recruitment end date
30/09/2010
Locations
Countries of recruitment
Germany
Trial participating centre
salus clinic Lindow
Strasse nach Guehlen 10
Lindow
16835
Germany
Sponsor information
Organisation
Radboud University Nijmegen
Sponsor details
PO Box 9104
Nijmegen
6500 HE
Netherlands
+31-24-3610082
secr@bsi.ru.nl
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
German Pension Fund (Deutsche Rentenversicherung Bund)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
Intention to publish date
01/12/2020
Participant level data
Available on request
Basic results (scientific)
Publication list