Condition category
Not Applicable
Date applied
05/08/2020
Date assigned
04/09/2020
Last edited
03/09/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

http://www.ru.nl/english/

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

Publication citations

Additional files

Editorial Notes

03/09/2020: Trial’s existence confirmed by Deutsche Rentenversicherung Berlin Brandenburg