Alcohol DependenceNCT03338361
Research on the Efficacy of the "T.O.P. Computer Training" Procedure in the Treatment of Alcohol Dependence
A study testing active approach avoidance training and active visual probe training in people with Alcohol Dependence, run by University Ghent at 1 site in Belgium.
Trial summary
The investigators evaluate the efficacy of a computerised program (T.O.P. tool) consisting of an approach avoidance training (AAT) (to retrain action tendencies for alcohol-related stimuli), a visual probe training (VPT) (to retrain attentional bias for alcohol-related stimuli) and the combination of both training… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- active approach avoidance training and active visual probe training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 247 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Oct 2017to 29 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hospitalized alcohol-dependent patients, choosing for abstinence en committed to treatment
- detoxification (with benzodiazepines) is terminated
- Dutch speaking
Who cannot join
- neurological condition, such as Korsakoff syndrome
- cognitive problems (cut-off <26/30 on the Montral Cognitive Assessment)
- psychotic disorders
- visual and motor problems at the hands
- non-Dutch speaking
- mental retardation
- patients who are illiterate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Approach Avoidance and Attentional Bias Retraining in Alcohol-dependent Patients: a Randomized Controlled Trial in a Clinical Setting
The investigators evaluate the efficacy of a computerised program (T.O.P. tool) consisting of an approach avoidance training (AAT) (to retrain action tendencies for alcohol-related stimuli), a visual probe training (VPT) (to retrain attentional bias for alcohol-related stimuli) and the combination of both training procedures versus placebo training, as an add-on to treatment as usual (psycho-education and cognitive behavioral therapy).
The investigators include hospitalized detoxified alcohol-dependent patients, who receive a four week training procedure, existing of a pre-assessment, 6 training sessions and a post-assessment.
Read more
Outcome measures consist of behavioral measures (consumption of alcohol - self report over 1 year), questionnaires (AUDIT; craving on 9-point likert scale) and approach avoidance and visual probe measurement tasks.
A six month and 1 year follow-up is included (behavioral measures and AUDIT). Further, the investigators will also assess credibility (9-point likert scale) of the training procedure before the start of the training and immediately after the assessment of the AAT and VPT training.
- Conditions
- Alcohol Dependence
- Being tested
- active approach avoidance training and sham visual probe training, sham approach avoidance training and active visual probe training, active approach avoidance training and active visual probe training, sham approach avoidance training and sham visual probe training
- Keywords
- approach avoidance training, attentional bias training, alcohol depencence, relapse
- Medical subject headings
- Alcoholism, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active approach avoidance training and sham visual probe trainingBehavioural
patients receive active AAT training and sham VPT training
sham approach avoidance training and active visual probe trainingBehavioural
patients receive sham AAT training and active VPT training
active approach avoidance training and active visual probe trainingBehavioural
patients receive active AAT training and active VPT training
sham approach avoidance training and sham visual probe trainingBehavioural
patients receive sham AAT training and sham VPT training
| Study group | Role | What they receive |
|---|---|---|
| AAT active - VPT sham | Experimental | Approach avoidance training active intervention and visual probe training sham intervention Receives: Behavioral: active approach avoidance training and sham visual probe training |
| VPT active - AAT sham | Experimental | Visual probe training active condition and approach avoidance training sham condition Receives: Behavioral: sham approach avoidance training and active visual probe training |
| AAT active - VPT active | Experimental | Approach avoidance training active condition and visual probe training active condition Receives: Behavioral: active approach avoidance training and active visual probe training |
| AAT sham - VPT sham | Sham comparator | Approach avoidance training sham condition and visual probe training sham condition Receives: Behavioral: sham approach avoidance training and sham visual probe training |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in drink behavior
AUDIT score
Measured: baseline, at 6 months and 1-year post training: change in auditscores between baseline, 6 months and 1-year post-training, and differences between groups
Secondary outcomes (2)
change in Retraining attentional bias
The effect on a VPT task
Measured: baseline and between 1 and 7 days after completion of the 6 training sessions: change
change in Retraining action tendencies
The effect on a AAT task
Measured: baseline and between 1 and 7 days after completion of the 6 training sessions: change in action tendencies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start26 Oct 2017
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- PZ Heilig Hart, PZ Sint-Camillus, University of Amsterdam
- Responsible party
- Sponsor
- Investigators
- sarah C herremans, PhD, MD, Principal investigator, UZ Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338361
- Sponsor's protocol ID
- EC/2017/1079
- Status last verified
- Dec 2021
- First submitted
- 25 Oct 2017
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Approach Avoidance and Attentional Bias Retraining in Alcohol-dependent Patients: a Randomized Controlled Trial in a Clinical Setting
- ClinicalTrials.gov ID
- NCT03338361
- Acronym / sponsor ID
- EC/2017/1079
- Conditions
- Alcohol Dependence
- Keywords
- approach avoidance training, attentional bias training, alcohol depencence, relapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- PZ Heilig Hart, PZ Sint-Camillus, University of Amsterdam
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators evaluate the efficacy of a computerised program (T.O.P. tool) consisting of an approach avoidance training (AAT) (to retrain action tendencies for alcohol-related stimuli), a visual probe training (VPT) (to retrain attentional bias for alcohol-related stimuli) and the combination of both training procedures versus placebo training, as an add-on to treatment as usual (psycho-education and cognitive behavioral therapy).
The investigators include hospitalized detoxified alcohol-dependent patients, who receive a four week training procedure, existing of a pre-assessment, 6 training sessions and a post-assessment.
Outcome measures consist of behavioral measures (consumption of alcohol - self report over 1 year), questionnaires (AUDIT; craving on 9-point likert scale) and approach avoidance and visual probe measurement tasks.
A six month and 1 year follow-up is included (behavioral measures and AUDIT). Further, the investigators will also assess credibility (9-point likert scale) of the training procedure before the start of the training and immediately after the assessment of the AAT and VPT training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AAT active - VPT sham | Experimental | Behavioral: active approach avoidance training and sham visual probe trainingApproach avoidance training active intervention and visual probe training sham intervention |
| VPT active - AAT sham | Experimental | Behavioral: sham approach avoidance training and active visual probe trainingVisual probe training active condition and approach avoidance training sham condition |
| AAT active - VPT active | Experimental | Behavioral: active approach avoidance training and active visual probe trainingApproach avoidance training active condition and visual probe training active condition |
| AAT sham - VPT sham | Sham comparator | Behavioral: sham approach avoidance training and sham visual probe trainingApproach avoidance training sham condition and visual probe training sham condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- hospitalized alcohol-dependent patients, choosing for abstinence en committed to treatment
- detoxification (with benzodiazepines) is terminated
- Dutch speaking
Key exclusion criteria (7 listed)
- neurological condition, such as Korsakoff syndrome
- cognitive problems (cut-off <26/30 on the Montral Cognitive Assessment)
- psychotic disorders
- visual and motor problems at the hands
- non-Dutch speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active approach avoidance training and sham visual probe trainingpatients receive active AAT training and sham VPT training | Behavioural | AAT active - VPT sham |
| sham approach avoidance training and active visual probe trainingpatients receive sham AAT training and active VPT training | Behavioural | VPT active - AAT sham |
| active approach avoidance training and active visual probe trainingpatients receive active AAT training and active VPT training | Behavioural | AAT active - VPT active |
| sham approach avoidance training and sham visual probe trainingpatients receive sham AAT training and sham VPT training | Behavioural | AAT sham - VPT sham |
Primary outcome
change in drink behavior
Time frame: baseline, at 6 months and 1-year post training: change in auditscores between baseline, 6 months and 1-year post-training, and differences between groups
AUDIT score
2 secondary outcomes
change in Retraining attentional bias
Time frame: baseline and between 1 and 7 days after completion of the 6 training sessions: change
change in Retraining action tendencies
Time frame: baseline and between 1 and 7 days after completion of the 6 training sessions: change in action tendencies
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sarah C herremans, PhD, MD principal investigator
UZ Gent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active approach avoidance training and active visual probe training in people with Alcohol Dependence, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in drink behavior (time frame: baseline, at 6 months and 1-year post training: change in auditscores between baseline, 6 months and 1-year post-training, and differences between groups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.