Alcohol Use DisorderIMBANCT06211959
Evaluating the Effectiveness of Implementation Intentions to Strengthen Approach-avoidance Training
A study testing Approach Bias Modification with Implementation Intentions in people with Alcohol Use Disorder, run by Clinique de la Mitterie at 1 site in France.
Trial summary
Approach Bias Modifcation corresponds to computerized interventions designed to change a cognitive bias (i.e., the approach bias) that may contribute to the maintenance of Alcohol Use Disorder. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Approach Bias Modification with Implementation Intentions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2021to 2 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- care at the clinic for Alcohol Use Disorder,
- have an e-mail address,
- written and spoken French,
- signing informed consent.
Who cannot join
- not currently remissioned for the Alcohol Use Disorder,
- no other Substance Use Disorder (except tobaco one)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique la Mitterie
Lille, 59160
Michaël RACODON, Ph.D, +33320223457, mracodon@clinique-mitterie.com
Nicolas KACZMAREK, Ph.D
About this study
Official title: Evaluating the Effectiveness of Implementation Intentions to Strengthen Approach-avoidance Training : Pilot Study on Alcohol Use Disorder
Approach Bias Modifcation corresponds to computerized interventions designed to change a cognitive bias (i.e., the approach bias) that may contribute to the maintenance of Alcohol Use Disorder. This study aims to compare the effectiveness of a classical Approach Bias Modification program, an Approach Bias Modification program integrating a planning strategy (i.e., implementation intentions) and a Sham-training to decrease the approach bias (from pre to post-test), and Alcohol Use Disorder symptomatology (from baseline to follow-up). 112 patients will be recruited for this study.
Read the detailed description
The Approach Bias is considered to be a maintenance factor of Alcohol Use Disorder. It correspond to the relative ease to approach alcohol rather than to avoid it. Approach Bias Modifcation correspond to computerized interventiond designed to change it by training participants to emit avoidance response (e.g., pull the joystick away) toward alcohol stimuli (e.g., alcohol pictures). Those programs have shown their effectiveness to promote abstinence among Alcohol Use Disorder patients. This study aims to compare the effectiveness of a classical Approach Bias Modification program to the one of a similar program integrating a planning add-on strategy named implementation intentions and to a Sham-training. 112 patients will be recruited for this study at Clinic de la Mitterie rehab center. During their hospitalization, participants will have to complete: a baseline that assess Alcohol Use Disorder symptomatology (i.e., alcohol consumption, alcohol consumption, and alcohol-related consequences) and other alcohol-related variables (e.g., motivation and self-efficacy), a pre-test that assess the approach bias, 6 sessions of one of the three experimental interventions {classical Approach Bias Modification, Approach Bias Modification with Implementation Intentions, Sham-training}, and a post-test that reassess the approach bias. After their hospitalization, they will have to complete a 2, 4 and 6-month online follow-up that reasses Alcohol Use Disorder symptomatology. It is expect that the Approach Bias Modification program with implementation intentions will decrease the approach bias and Alcohol Use Disorder symptomatology more than the classical program, that will also decrease it more than the Sham-training.
- Conditions
- Alcohol Use Disorder
- Being tested
- Approach Bias Modification with Implementation Intentions
- Keywords
- cognitive bias, Alcohol Use Disorder
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Approach Bias Modification with Implementation IntentionsBehavioural
Also called Classical Approach Bias Modification
Participants in each experimental condition will perform different variants of the Approach-Avoidance Task (i.e., a task that is widely used in the litterature to assess and modify the approach bias toward alcohol - the relative ease to approach alcohol rather than to avoid it). Participants in the classical Approach Bias Modification conditions will perform a version of this task which will train them to (almost-)systematically emit an avoidance response toward alcohol ; Participants in the Approach Bias Modification with Implementation Intentions condition will perform the same version of the task but will additionnaly have to complete a planning intervention (i.e., implementation intentions) to help them avoiding alcohol; Participants in the Sham-training condition will perform a version of this task which require them to approach alcohol as often as they have to avoid it (i.e., no real training).
| Study group | Role | What they receive |
|---|---|---|
| Classical Approach Bias Modification | Experimental | The 3 arms will follow a similar procedure, except that they will receive 3 different experimental interventions, dependly on their conditions. Receives: Behavioral: Approach Bias Modification with Implementation Intentions |
| Approach Bias Modification with Implementation Intentions | Experimental | The 3 arms will follow a similar procedure, except that they will receive 3 different experimental interventions, dependly on their conditions. Receives: Behavioral: Approach Bias Modification with Implementation Intentions |
| Sham-training | Placebo comparator | The 3 arms will follow a similar procedure, except that they will receive 3 different experimental interventions, dependly on their conditions. Receives: Behavioral: Approach Bias Modification with Implementation Intentions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Approach-Avoidance Task (AAT)
The approach bias toward alcohol
Measured: 2 weeks
Secondary outcomes (1)
Alcohol consumption
The Alcohol Use Disorder Identification Test - Consumption (AUDIT)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start2 Jan 2021
- Primary completion1 Jul 2022
- Study completion2 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-centre, randomised, superiority study
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique de la Mitterie
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michaël RACODON, Clinique de la Mitterie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211959
- Sponsor's protocol ID
- 2020-A02415-34
- Acronym
- IMBA
- Status last verified
- Jan 2026
- First submitted
- 26 Dec 2023
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. sign an informed consent and to complete a baseline that assess the secondary outcomes measures as well as other alcohol-related measures (e.g., motivation and self-efficacy to change alcohol consumption). 2. complete a pre-test that asssess the primary outcome measure (i.e., the approach bias). 3. receive 6 session of their respective experimental intervention 4. complete a post-test to reassess the primary outcome measure (i.e., the approach bias). Follow-up Phase. After participants hospitalization, participants will have to complete a 2, 4, and 6-month online follow-up that reassess the secondary outcome measures (i.e., alcohol consumption, alcohol dependence, and alcohol-related-consequences).
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Implementation Intentions to Strengthen Approach-avoidance Training : Pilot Study on Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT06211959
- Acronym / sponsor ID
- IMBA / 2020-A02415-34
- Conditions
- Alcohol Use Disorder
- Keywords
- cognitive bias, Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Clinique de la MitterieUniversity, hospital or other
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 2 Apr 2026 (estimated)
- First posted
- 18 Jan 2024 (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.
Approach Bias Modifcation corresponds to computerized interventions designed to change a cognitive bias (i.e., the approach bias) that may contribute to the maintenance of Alcohol Use Disorder. This study aims to compare the effectiveness of a classical Approach Bias Modification program, an Approach Bias Modification program integrating a planning strategy (i.e., implementation intentions) and a Sham-training to decrease the approach bias (from pre to post-test), and Alcohol Use Disorder symptomatology (from baseline to follow-up). 112 patients will be recruited for this study.
Detailed description
The Approach Bias is considered to be a maintenance factor of Alcohol Use Disorder. It correspond to the relative ease to approach alcohol rather than to avoid it. Approach Bias Modifcation correspond to computerized interventiond designed to change it by training participants to emit avoidance response (e.g., pull the joystick away) toward alcohol stimuli (e.g., alcohol pictures). Those programs have shown their effectiveness to promote abstinence among Alcohol Use Disorder patients. This study aims to compare the effectiveness of a classical Approach Bias Modification program to the one of a similar program integrating a planning add-on strategy named implementation intentions and to a Sham-training. 112 patients will be recruited for this study at Clinic de la Mitterie rehab center. During their hospitalization, participants will have to complete: a baseline that assess Alcohol Use Disorder symptomatology (i.e., alcohol consumption, alcohol consumption, and alcohol-related consequences) and other alcohol-related variables (e.g., motivation and self-efficacy), a pre-test that assess the approach bias, 6 sessions of one of the three experimental interventions {classical Approach Bias Modification, Approach Bias Modification with Implementation Intentions, Sham-training}, and a post-test that reassess the approach bias. After their hospitalization, they will have to complete a 2, 4 and 6-month online follow-up that reasses Alcohol Use Disorder symptomatology. It is expect that the Approach Bias Modification program with implementation intentions will decrease the approach bias and Alcohol Use Disorder symptomatology more than the classical program, that will also decrease it more than the Sham-training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- single-centre, randomised, superiority study
| Arm | Type | Receives |
|---|---|---|
| Classical Approach Bias Modification | Experimental | Behavioral: Approach Bias Modification with Implementation IntentionsThe 3 arms will follow a similar procedure, except that they will receive 3 different experimental interventions, dependly on their conditions. |
| Approach Bias Modification with Implementation Intentions | Experimental | Behavioral: Approach Bias Modification with Implementation IntentionsThe 3 arms will follow a similar procedure, except that they will receive 3 different experimental interventions, dependly on their conditions. |
| Sham-training | Placebo comparator | Behavioral: Approach Bias Modification with Implementation IntentionsThe 3 arms will follow a similar procedure, except that they will receive 3 different experimental interventions, dependly on their conditions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- care at the clinic for Alcohol Use Disorder,
- have an e-mail address,
- written and spoken French,
- signing informed consent.
Key exclusion criteria (2 listed)
- not currently remissioned for the Alcohol Use Disorder,
- no other Substance Use Disorder (except tobaco one)
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 |
|---|---|---|
| Approach Bias Modification with Implementation IntentionsAlso: Classical Approach Bias ModificationParticipants in each experimental condition will perform different variants of the Approach-Avoidance Task (i.e., a task that is widely used in the litterature to assess and modify the approach bias toward alcohol - the relative ease to approach alcohol rather than to avoid it). Participants in the classical Approach Bias Modification conditions will perform a version of this task which will train them to (almost-)systematically emit an avoidance response toward alcohol ; Participants in the Approach Bias Modification with Implementation Intentions condition will perform the same version of the task but will additionnaly have to complete a planning intervention (i.e., implementation intentions) to help them avoiding alcohol; Participants in the Sham-training condition will perform a version of this task which require them to approach alcohol as often as they have to avoid it (i.e., no real training). | Behavioural | Approach Bias Modification with Implementation Intentions, Classical Approach Bias Modification, Sham-training |
Primary outcome
Approach-Avoidance Task (AAT)
Time frame: 2 weeks
The approach bias toward alcohol
1 secondary outcome
Alcohol consumption
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Yes. 1. sign an informed consent and to complete a baseline that assess the secondary outcomes measures as well as other alcohol-related measures (e.g., motivation and self-efficacy to change alcohol consumption). 2. complete a pre-test that asssess the primary outcome measure (i.e., the approach bias). 3. receive 6 session of their respective experimental intervention 4. complete a post-test to reassess the primary outcome measure (i.e., the approach bias). Follow-up Phase. After participants hospitalization, participants will have to complete a 2, 4, and 6-month online follow-up that reassess the secondary outcome measures (i.e., alcohol consumption, alcohol dependence, and alcohol-related-consequences).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Approach Bias Modification with Implementation Intentions in people with Alcohol Use Disorder, run by Clinique de la Mitterie at 1 site in France.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 Jan 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas KACZMAREK (+33320223303, nkaczmarek@clinique-mitterie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Approach-Avoidance Task (AAT) (time frame: 2 weeks). 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 12 Jan 2026.