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

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Approach Bias Modification with Implementation Intentions

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 Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas KACZMAREK; Phone Number: +33320223303; Email: nkaczmarek@clinique-mitterie.com

Study Locations

• France
  • Lille, France, 59160
    • Recruiting
    • Clinique la Mitterie
    • Contact: Michaël RACODON, Ph.D; Phone Number: +33320223457; Email: mracodon@clinique-mitterie.com
    • Principal Investigator: Nicolas KACZMAREK, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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).; Other Names: Classical Approach Bias Modification
Experimental: 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.	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).; Other Names: Classical Approach Bias Modification
Placebo Comparator: Sham-training; The 3 arms will follow a similar procedure, except that they will receive 3 different experimental interventions, dependly on their conditions.	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).; Other Names: Classical Approach Bias Modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Approach-Avoidance Task (AAT)	The approach bias toward alcohol	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol consumption	The Alcohol Use Disorder Identification Test - Consumption (AUDIT)	2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol dependence	The Short Alcohol Dependence Data questionnaire (SAAD)	2 weeks
Alcohol-related consequences	The Short Inventory of Problems - Revised (SIP-R)	2 weeks

Collaborators and Investigators

• Sponsor: Clinique de la Mitterie

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Estimated): April 2, 2026

Study Registration Dates

• First Submitted: December 26, 2023
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Alcohol Use Disorder; cognitive bias
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism
• Other Study ID Numbers: 2020-A02415-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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).

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No