Is alcohol-avoidance training effective and feasible in regular treatment?
| ISRCTN | ISRCTN18432640 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18432640 |
- Submission date
- 18/02/2021
- Registration date
- 22/02/2021
- Last edited
- 22/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
An alcohol use disorder (AUD) is drinking that causes distress and harm. Alcohol-Avoidance Training (AAT) using a PC and joystick is a promising new treatment for patients with AUD, helping them to avoid relapse. However, it is not known whether AAT also works in practice in different types of clinics. The aim of this study is to find out whether AAT reduces relapse rates in currently abstinent alcohol-dependent patients in 10 German rehabilitation clinics.
Who can participate?
Alcohol-dependent inpatients who are currently abstinent and receive treatment at one of 10 German rehabilitation clinics.
What does the study involve?
Patients are randomly allocated to the active training group or the control group. In addition to usual treatment, all patients in the active training group receive six sessions of AAT. During AAT, patients use a joystick to push away pictures of alcoholic drinks and pull closer pictures of non-alcoholic drinks. Patients in the control group receive only treatment-as-usual.
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 Salus Clinic Lindow (Germany)
When is the study starting and how long is it expected to run for?
July 2010 to January 2015
Who is funding the study?
The German Pension Fund (Deutsche Rentenversicherung Bund) (Germany)
Who is the main contact?
Prof. Dr Mike Rinck
m.rinck@psych.ru.nl
Contact information
Scientific
PO Box 9104
Nijmegen
6500 HE
Netherlands
| Phone | +31 (0)243612154 |
|---|---|
| m.rinck@psych.ru.nl |
Study information
| Study design | Multicenter interventional non-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effectiveness and feasibility of alcohol-avoidance training: a phase 4 multi-center randomized controlled trial |
| Study acronym | AATMC |
| Study hypothesis | Active Alcohol-Avoidance Training reduces relapse rates in currently abstinent alcohol-dependent patients in 10 German rehabilitation clinics. |
| Ethics approval(s) | Approved 02/02/2011, Ethics Board: Ethikkommission der Fakultaet Human- und Sozialwissenschaften der Universität Chemnitz (Ethics Committee of the Dept. of Human and Social Sciences, Chemnitz University, Technical University Chemnitz, 09107 Chemnitz, Germany; +49 (0)371-53134535; ethik@hsw.tu-chemnitz.de), ref: 02022011 |
| Condition | Prevention of relapse in currently abstinent patients with Alcohol Use Disorder |
| Intervention | During their 3-months stay at one of the 10 participating rehabilitation clinics, currently abstinent alcohol-dependent patients are randomly assigned by coin toss to an active training group or a control group. Active training condition: In addition to treatment-as-usual, patients complete six 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. Total duration of follow-up: 12 months |
| Intervention type | Behavioural |
| Primary outcome measure | Relapse measured using a standard questionnaire given on paper or via telephone at 3-months, 6-months, and 12-months follow-up |
| Secondary outcome measures | 1. Evaluation of the training by patients, measured using a questionnaire at the end of the training 2. Return rate recorded at each follow-up point per clinic |
| Overall study start date | 01/07/2010 |
| Overall study end date | 01/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1400 (140 per clinic) |
| Total final enrolment | 1586 |
| Participant inclusion criteria | Alcohol dependence, currently abstinent |
| Participant exclusion criteria | 1. Non-native speaker of German 2. History of schizophrenia or psychotic disorders 3. Visual or hand-motor handicaps 4. Strong withdrawal symptoms 5. Severe neurological disorders |
| Recruitment start date | 01/09/2012 |
| Recruitment end date | 01/10/2013 |
Locations
Countries of recruitment
- Germany
Study participating centres
Bad Neuenahr-Ahrweiler
53474
Germany
Oppenweiler
71570
Germany
Guetersloh
33334
Germany
Schmallenberg
57392
Germany
Hanstedt
21271
Germany
Mittenwalde OT Motzen
15749
Germany
Bad Essen
49152
Germany
Friedrichsdorf
61381
Germany
Huerth
50354
Germany
Sponsor information
University/education
Behavioural Science Institute
PO Box 9104
Nijmegen
6500 HE
Netherlands
| Phone | +31 (0)24 3610082 |
|---|---|
| secr@bsi.ru.nl | |
| Website | http://www.ru.nl/english/ |
"ROR" |
https://ror.org/016xsfp80 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. No additional documents are available. |
| IPD sharing plan | Anonymized participant-level data will be available upon request from Mike Rinck (m.rinck@psych.ru.nl). |
Editorial Notes
22/02/2021: Trial's existence confirmed by Ethics Board: Ethikkommission der Fakultaet Human- und Sozialwissenschaften der Universität Chemnitz.
