My Choices: Efficacy and Implementation Study

NCT ID: NCT05358613

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-28
• Study Completion Date: 2023-05-14

Brief Summary

The aim of the study is to assess the efficacy of the My Choices - Alcohol program by comparing alcohol-use of people before and after doing the program to people that did not do the program on the same period of time (3 months).

Detailed Description

People with an alcohol addiction problem consume an average of 26.3 (sd = 12.4) drinks per week (Cournoyer et al., 2010). To observe a decrease of 25% in this average number of drinks for the group participating in the program " My Choices " immediately compared to the delayed group at 3 months, we need a sample size of 100 participants. This calculation assumes an alpha of 5%, a power of 80% and unbalanced groups due to the randomization method used. Considering an attrition rate of 11.3% at 3 months and 20% at 6 months (Tremblay et al., Submitted), it will be necessary to recruit at least 120 participants to maintain the required number for analyses.

References Cournoyer, L.-G., Simoneau, H., Landry, M., Tremblay, J., & Patenaude, C. (2010). Évaluation d'implantation du programme Alcochoix+ (FQRSC #2008-TO-120890). F. q. d. r. s. l. s. e. l. culture.

Tremblay, J., Dufour, M., Bertrand, K., Saint-Jacques, M., Ferland, F., Blanchette-Martin, N., Savard, A.-C., Côté, M., Berbiche, D., & Beaulieu, M. (Submitted). Efficacy of a Randomized Controlled Trial of Integrative Couple Treatment for Pathological Gambling (ICT-PG): 10-Month Follow-Up. Journal of Consulting and Clinical Psychology.

Conditions

Alcohol Use Disorder, Mild; Alcohol Use, Unspecified

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate treatment

The My Choices program will be offered immediately (maximum 10 working days from their first research interview) to the participants of this group.

The treatment will be dispensed as usual, wich means there are no special conditions that need to be respected specifically for the study.

Group Type: EXPERIMENTAL

My Choices

Intervention Type: BEHAVIORAL

The My Choices program is an harm reduction program to modify substance use habits. It is based on the Miller & Rollnick Motivational interviewing as well as Deci and Ryan's Self-determination theory and Bandura's social learning theory.

It is presented as a guide, divided in 6 phases. In every phase, participants will find, in the guide, some auto-observation exercises about their alcohol use habits and other aspects about their quality of life, reflexions and information about alcohol. The participants are also invited to note the number of standard units of alcohol they use on every occasion.

Waiting list

The My Choices program will be offered 3 months after the first research interview to the participants in this group.

The treatment will be dispensed as usual, wich means there are no special conditions that need to be respected specifically for the study.

Group Type: ACTIVE_COMPARATOR

My Choices

Intervention Type: BEHAVIORAL

The My Choices program is an harm reduction program to modify substance use habits. It is based on the Miller & Rollnick Motivational interviewing as well as Deci and Ryan's Self-determination theory and Bandura's social learning theory.

It is presented as a guide, divided in 6 phases. In every phase, participants will find, in the guide, some auto-observation exercises about their alcohol use habits and other aspects about their quality of life, reflexions and information about alcohol. The participants are also invited to note the number of standard units of alcohol they use on every occasion.

Interventions

My Choices

The My Choices program is an harm reduction program to modify substance use habits. It is based on the Miller & Rollnick Motivational interviewing as well as Deci and Ryan's Self-determination theory and Bandura's social learning theory.

It is presented as a guide, divided in 6 phases. In every phase, participants will find, in the guide, some auto-observation exercises about their alcohol use habits and other aspects about their quality of life, reflexions and information about alcohol. The participants are also invited to note the number of standard units of alcohol they use on every occasion.

Intervention Type: BEHAVIORAL

Other Intervention Names

Alcochoix+

Eligibility Criteria

Inclusion Criteria

• Adults with at risk alcohol use (alcohol use over the Canadian low-risk alcohol drinking guidelines, without or with low consequences associated with their alcohol use).

Exclusion Criteria

• Score at the DEBA (Assessment and Screening of Assistance needs) indicates a need for specialized treatment.
• Hospitalization for mental health problems in the last 30 days
• People with unstable mental health condition

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université du Québec à Trois-Rivières

OTHER

Sponsor Role: lead

Responsible Party

Joël Tremblay

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joël Tremblay, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Université du Québec à Trois-Rivières

Locations

Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean

Jonquière, Quebec, Canada

Centre Intégré de Santé Services Sociaux de Laval

Laval, Quebec, Canada

Centre intégré de Santé et de Services Sociaux de Chaudière-Appalaches

Lévis, Quebec, Canada

Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale-Nationale

Québec, , Canada

Université du Québec à Trois-Rivières

Québec, , Canada

Countries

Canada

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

CER-18-251-10.02

Identifier Type: -

Identifier Source: org_study_id