Alcohol-avoidance training for alcohol-dependent patients
| ISRCTN | ISRCTN97173360 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97173360 |
- Submission date
- 05/08/2020
- Registration date
- 04/09/2020
- Last edited
- 28/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Scientific
PO Box 9104
Nijmegen
6500 HE
Netherlands
| Phone | +31 243612154 |
|---|---|
| m.rinck@psych.ru.nl |
Public
PO Box 9104
Nijmegen
6500 HE
Netherlands
| Phone | +31 243612154 |
|---|---|
| m.rinck@psych.ru.nl |
Study information
| Study design | Single-center interventional blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Affective comorbidity moderates the relapse-preventive effect of alcohol-related approach bias modification |
| Study objectives | Active Alcohol-Avoidance Training reduces relapse rates in comorbid and non-comorbid, currently abstinent alcohol-dependent patients |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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. Added 28/01/2021: Randomization procedure: For each patient, the randomization procedure involved a 40% chance to receive the active training condition and a 60% chance to receive the control condition. The researchers had to deviate from the usual 50:50 ratio because the clinic did not have sufficient resources (PCs, lab time, assistant time) to give the intensive 12-session training to 50% of the patients. Blinding: The participants were not blinded during the training, but researchers and interviewers were blinded regarding the outcome. The researchers who worked with the training data did not know the clinical outcome, and the therapists who administered the 1-year follow-up interviews did not know whether the patient had participated in a study at all (let alone in which experimental condition). Moreover, training data and clinical data were combined only after both data sets had been finalized. |
| Intervention type | Behavioural |
| 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 study start date | 01/01/2009 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 720 |
| Total final enrolment | 729 |
| Key inclusion criteria | 1. Alcohol-dependent, currently abstinent 2. Aged ≥ 18 years |
| Key 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 Added 28/01/2021: 6. Participation in the study by Eberl et al. (2013) or any other earlier study |
| Date of first enrolment | 28/09/2009 |
| Date of final enrolment | 30/09/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
Lindow
16835
Germany
Sponsor information
University/education
PO Box 9104
Nijmegen
6500 HE
Netherlands
| Phone | +31-24-3610082 |
|---|---|
| secr@bsi.ru.nl | |
| Website | http://www.ru.nl/english/ |
"ROR" |
https://ror.org/016xsfp80 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/04/2021 |
|---|---|
| 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. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Editorial Notes
28/01/2021: The interventions and exclusion criteria were updated. The intention to publish date was changed from 01/12/2020 to 01/04/2021.
03/09/2020: Trial’s existence confirmed by Deutsche Rentenversicherung Berlin Brandenburg
