Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2025-12-26 @ 7:02 AM
Study NCT ID:
NCT06211959
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2023-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Effectiveness of Implementation Intentions to Strengthen Approach-avoidance Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'single-centre, randomised, superiority study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2023-12-26', 'studyFirstSubmitQcDate': '2024-01-09', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Alcohol dependence', 'timeFrame': '2 weeks', 'description': 'The Short Alcohol Dependence Data questionnaire (SAAD)'}, {'measure': 'Alcohol-related consequences', 'timeFrame': '2 weeks', 'description': 'The Short Inventory of Problems - Revised (SIP-R)'}], 'primaryOutcomes': [{'measure': 'Approach-Avoidance Task (AAT)', 'timeFrame': '2 weeks', 'description': 'The approach bias toward alcohol'}], 'secondaryOutcomes': [{'measure': 'Alcohol consumption', 'timeFrame': '2 weeks', 'description': 'The Alcohol Use Disorder Identification Test - Consumption (AUDIT)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cognitive bias', 'Alcohol Use Disorder'], 'conditions': ['Alcohol Use Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* care at the clinic for Alcohol Use Disorder,\n* have an e-mail address,\n* written and spoken French,\n* signing informed consent.\n\nExclusion Criteria:\n\n* not currently remissioned for the Alcohol Use Disorder,\n* no other Substance Use Disorder (except tobaco one)'}, 'identificationModule': {'nctId': 'NCT06211959', 'acronym': 'IMBA', 'briefTitle': 'Evaluating the Effectiveness of Implementation Intentions to Strengthen Approach-avoidance Training', 'organization': {'class': 'OTHER', 'fullName': 'Clinique de la Mitterie'}, 'officialTitle': 'Evaluating the Effectiveness of Implementation Intentions to Strengthen Approach-avoidance Training : Pilot Study on Alcohol Use Disorder', 'orgStudyIdInfo': {'id': '2020-A02415-34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Classical Approach Bias Modification', 'description': 'The 3 arms will follow a similar procedure, except that they will receive 3 different experimental interventions, dependly on their conditions.', 'interventionNames': ['Behavioral: Approach Bias Modification with Implementation Intentions']}, {'type': 'EXPERIMENTAL', 'label': 'Approach Bias Modification with Implementation Intentions', 'description': 'The 3 arms will follow a similar procedure, except that they will receive 3 different experimental interventions, dependly on their conditions.', 'interventionNames': ['Behavioral: Approach Bias Modification with Implementation Intentions']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham-training', 'description': 'The 3 arms will follow a similar procedure, except that they will receive 3 different experimental interventions, dependly on their conditions.', 'interventionNames': ['Behavioral: Approach Bias Modification with Implementation Intentions']}], 'interventions': [{'name': 'Approach Bias Modification with Implementation Intentions', 'type': 'BEHAVIORAL', 'otherNames': ['Classical Approach Bias Modification'], 'description': '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).', 'armGroupLabels': ['Approach Bias Modification with Implementation Intentions', 'Classical Approach Bias Modification', 'Sham-training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59160', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Michaël RACODON, Ph.D', 'role': 'CONTACT', 'email': 'mracodon@clinique-mitterie.com', 'phone': '+33320223457'}, {'name': 'Nicolas KACZMAREK, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique la Mitterie', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Nicolas KACZMAREK', 'role': 'CONTACT', 'email': 'nkaczmarek@clinique-mitterie.com', 'phone': '+33320223303'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', '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).\n2. complete a pre-test that asssess the primary outcome measure (i.e., the approach bias).\n3. receive 6 session of their respective experimental intervention\n4. complete a post-test to reassess the primary outcome measure (i.e., the approach bias).\n\nFollow-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).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique de la Mitterie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of clinical research', 'investigatorFullName': 'Michaël RACODON', 'investigatorAffiliation': 'Clinique de la Mitterie'}}}}