NCT06211959

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2026

Completed
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

December 26, 2023

Last Update Submit

January 9, 2026

Conditions

Keywords

cognitive biasAlcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Approach-Avoidance Task (AAT)

    The approach bias toward alcohol

    2 weeks

Secondary Outcomes (1)

  • Alcohol consumption

    2 weeks

Other Outcomes (2)

  • Alcohol dependence

    2 weeks

  • Alcohol-related consequences

    2 weeks

Study Arms (3)

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.

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.

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.

Behavioral: Approach Bias Modification with Implementation Intentions

Interventions

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).

Also known as: Classical Approach Bias Modification
Approach Bias Modification with Implementation IntentionsClassical Approach Bias ModificationSham-training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique la Mitterie

Lille, 59160, France

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: single-centre, randomised, superiority study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinical research

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 18, 2024

Study Start

January 2, 2021

Primary Completion

July 1, 2022

Study Completion

April 2, 2026

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
STUDY PROTOCOL

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