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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05620433
Other study ID # 2023-11154
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 8, 2023
Est. completion date January 2025

Study information

Verified date January 2024
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact José Côté, PhD
Phone 514 890-8000
Email jose.cote@umontreal.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate quantitatively and qualitatively a mobile application, Joint Effort, targeting safe cannabis use among consumers. This randomized controlled trial is currently conducted on the Joint Effort mobile application.


Description:

This online randomized controlled trial with parallel groups is conducted in Quebec (Canada). Interested participants are invited to visit the study's website at www.etudejointeeffort.ca The study's Website contains text explaining the study. After accepting the conditions and consenting, participants will enroll in the study by providing an email address and a pseudonym. Each participant will be validated through an email address check. After their enrolment, participants will receive a hyperlink via email to invite them to complete a baseline questionnaire. After completing the baseline questionnaire, participants will be randomly assigned by the computer system either to an experimental group (Joint Effort mobile application) or to a control group (brief normative feedback and standard information). Four weeks and eight weeks after the baseline questionnaire, participants will complete the online questionnaires again.


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date January 2025
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Aged between 18-35 years old - Be a non-medical cannabis user and have used in the last month - Understand, read and write French - Own a smartphone (iPhone) Exclusion Criteria: - None

Study Design


Intervention

Other:
Joint Effort
The Joint Effort intervention is available in the form of an iPhone mobile application (running on iOS 13 and higher) in French language. It aims to support young adults in school who have used cannabis in the past month into taking action on their cannabis use.
Brief normative feedback and standard information
The brief normative feedback is based on the frequency of cannabis use. Participants will also be offered basic reliable non-personalized information on lower-risk cannabis use in the form of official public websites.

Locations

Country Name City State
Canada Université de Montréal Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Protective Behavioral Strategies for Marijuana (PBSM-17) used The French version of the questionnaire translated by Côté et al. (2021) will be used. The 17 items proposed in the scale, each representing a behavioral protection strategy, are measured in terms of frequency of use on a six-point Likert-type scale (never, rarely, occasionally, sometimes, often and always). As indicated by its developers, the total score of the PBSM-17 is obtained by calculating the total score of each item and then converting this raw score into a standardized form (T-score) ranging from 15 to 73. 8 weeks
Secondary Change in intention to take action on cannabis use Intention is assessed by three items with a 7 points Likert Scale as recommended by Ajzen (2013): 1) "I intend to take action on my cannabis use within the next month" will be rated on a scale from 1 = strongly disagree to 7 = strongly agree; 2) "Over the next month, the chances of me taking action on my cannabis use are …" will be rated on a scale from 1=very low to 7=very high; 3) "Over the next month, I will be taking action on my cannabis use" will be rated on a scale from 1=very unlikely to 7=very likely. Intention items scores are tallied for an overall score (range of 3-21). 8 weeks
Secondary Cannabis use frequency The frequency of cannabis use will be assessed using a question previously used in the Quebec (Canada) Survey on Cannabis (2022). 8 weeks
Secondary Severity of Dependence Measured with the Severity of Dependence Scale (SDS) scale (Martin et al., 2006) which includes five items related to compulsive behaviors, concerns, anxiety, and feelings of loss of control in the context of cannabis use. Four of the items are scored on a Likert-type scale ranging from "never/almost never" (1) to "always" (4) and one item offers a scale ranging from "not difficult" (1) to "impossible" (4). Severity of dependance items scores are tallied for an overall score (range of 5-20). 8 weeks
Secondary Subjective engagement with the developed mobile application (acceptability) Subjective engagement (self-reported) will be measured using the validated French version (Fontaine et al., 2020) of the User Engagement Scale - Short Form (UES-SF) (O'Brien et al., 2018). This 12-item instrument serves to measure four dimensions of engagement: 1) aesthetic appeal; 2) focused attention; 3) perceived usability, and 4) reward factor. Possible answers range from strongly disagree (+1) to strongly agree (+5). The possible total score ranges between 12 and 60. The score for each item will be interpreted and the scores for each dimension will be compared to indicate which are rated more highly than others. 4 weeks
Secondary Number of screens viewed in the mobile application Objective data. This data will be collected automatically when users log into the application. 8 weeks
Secondary Total time of use of the mobile application Objective data. This data will be collected automatically when users log into the application. 8 weeks
Secondary Number of days the mobile application was used Objective data. This data will be collected automatically when users log into the application. 8 weeks
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