Clinical trial NCT06211959: Evaluating the Effectiveness of Implementation Intentions to Strengthen Approach-avoidance Training
Official title: Evaluating the Effectiveness of Implementation Intentions to Strengthen Approach-avoidance Training : Pilot Study on Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: cognitive bias
Alcohol Use Disorder
Lead sponsor: Clinique de la Mitterie
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 112
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-centre, randomised, superiority study
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Approach-Avoidance Task (AAT)
timeFrame: 2 weeks
Secondary outcomes:
measure: Alcohol consumption
timeFrame: 2 weeks
Other outcomes:
measure: Alcohol dependence
timeFrame: 2 weeks
measure: Alcohol-related consequences
timeFrame: 2 weeks
Locations:
city: Lille
country: France
facility: Clinique la Mitterie
Study officials:
References: