Evaluating the Effectiveness of Implementation Intentions to Strengthen Approach-avoidance Training

NCT ID: NCT06211959

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-02

Study Completion Date

2026-04-02

Brief Summary

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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

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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

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

single-centre, randomised, superiority study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Classical Approach Bias Modification

The 3 arms will follow a similar procedure, except that they will receive 3 different experimental interventions, dependly on their conditions.

Group Type EXPERIMENTAL

Approach Bias Modification with Implementation Intentions

Intervention Type BEHAVIORAL

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).

Approach Bias Modification with Implementation Intentions

The 3 arms will follow a similar procedure, except that they will receive 3 different experimental interventions, dependly on their conditions.

Group Type EXPERIMENTAL

Approach Bias Modification with Implementation Intentions

Intervention Type BEHAVIORAL

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).

Sham-training

The 3 arms will follow a similar procedure, except that they will receive 3 different experimental interventions, dependly on their conditions.

Group Type PLACEBO_COMPARATOR

Approach Bias Modification with Implementation Intentions

Intervention Type BEHAVIORAL

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).

Interventions

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Approach Bias Modification with Implementation Intentions

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).

Intervention Type BEHAVIORAL

Other Intervention Names

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Classical Approach Bias Modification

Eligibility Criteria

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Inclusion Criteria

* care at the clinic for Alcohol Use Disorder,
* have an e-mail address,
* written and spoken French,
* signing informed consent.

Exclusion Criteria

* not currently remissioned for the Alcohol Use Disorder,
* no other Substance Use Disorder (except tobaco one)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique de la Mitterie

OTHER

Sponsor Role lead

Responsible Party

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Michaël RACODON

Head of clinical research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinique la Mitterie

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nicolas KACZMAREK

Role: CONTACT

+33320223303

Facility Contacts

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Michaël RACODON, Ph.D

Role: primary

+33320223457

Other Identifiers

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2020-A02415-34

Identifier Type: -

Identifier Source: org_study_id

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