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

Alcohol Use Disorder Clinical Trial

— IMBA  

Official title:

Evaluating the Effectiveness of Implementation Intentions to Strengthen Approach-avoidance Training : Pilot Study on Alcohol Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06211959
• Other study ID #: 2020-A02415-34
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: Clinique de la Mitterie
• Contact: Nicolas KACZMAREK
• Phone: +33320223303
• Email: nkaczmarek[@]clinique-mitterie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
France	Clinique la Mitterie	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Clinique de la Mitterie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Alcohol dependence	The Short Alcohol Dependence Data questionnaire (SAAD)	2 weeks
Other	Alcohol-related consequences	The Short Inventory of Problems - Revised (SIP-R)	2 weeks
Primary	Approach-Avoidance Task (AAT)	The approach bias toward alcohol	2 weeks
Secondary	Alcohol consumption	The Alcohol Use Disorder Identification Test - Consumption (AUDIT)	2 weeks