My Choices: Efficacy and Implementation Study

Université du Québec à Trois-Rivières

Status: Completed

Conditions: Alcohol Use Disorder, Mild; Alcohol Use, Unspecified

Treatments: Behavioral: My Choices

Study type: Interventional

Funder types: Other

Identifiers

NCT05358613

CER-18-251-10.02

Details and patient eligibility

About

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).

Full 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.

Enrollment: 167 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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167 participants in 2 patient groups

Immediate treatment

Experimental group

Description:

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.

Treatment:

Behavioral: My Choices

Waiting list

Active Comparator group

Description:

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.

Treatment:

Behavioral: My Choices