REWIRE Program for Depression and Anxiety
(REWIRE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This two-phase, double-blind, balanced, parallel-group randomized controlled trial involves youth aged 12 to 17 years who experience symptoms of anxiety or depression and use social media for more than three hours per day.
In Phase 1, a small pilot group will participate in the REWIRE program to assess its feasibility, usability, and engagement before launching Phase 2. Results of the pilot will inform whether any modifications to the intervention are required and identify ways to increase adherence and reduce barriers.
In Phase 2, approximately 100 youth and their caregivers will be randomly assigned to one of two groups to evaluate the REWIRE program on anxiety and depression symptoms. One group will participate in the REWIRE program, which aims to reduce social media use to about half of usual levels while encouraging participation in positive offline activities such as spending time with friends, hobbies, physical activity, or time outdoors. The comparison group will receive psychoeducation about social media and health, but will not be asked to change their social media use. Both youth and caregivers will attend weekly group sessions over 12-weeks. Participants will also track their physical activity, complete questionnaires about mental health, daily activities, and social media use, and will provide daily smartphone usage screenshots. Youth will additionally take part in brain imaging scans and neurocognitive assessments before and after the program to explore how changes in social media use may be related to brain function. At the end of Phase 2, 20 participants will be randomly selected for interviews to explore their experiences with the intervention.
Additional secondary outcomes in Phase 2 include social phobia, social comparison, Fear of Missing Out (FOMO), loneliness, body esteem, disordered eating, social media disorder symptoms, cyberbullying, reinforcing efficacy of social media, impulsivity, suicidal ideations, well-being, executive functioning and cognition, while further assessing the feasibility.
Who Is on the Research Team?
Gary Goldfield
Principal Investigator
Children's Hospital of Eastern Ontario
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pilot Feasibility Phase
A single-arm pilot involving approximately 10 youth-caregiver dyads to evaluate recruitment feasibility, adherence to the SMU reduction target, usability of procedures, and acceptability of intervention components.
Randomized Controlled Trial
A balanced, parallel-group RCT enrolling approximately 100 youth-caregiver dyads to evaluate the REWIRE program on anxiety and depression symptoms.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- REWIRE Program
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Participants assigned to this arm will receive the active REWIRE intervention, which aims to improve mental health outcomes by modifying patterns of social media use and daily behaviour. This arm will be compared to the control group to evaluate the effectiveness of the intervention.
Participants in this arm will take part in an initial pilot phase designed to evaluate feasibility, usability, and participant engagement with the REWIRE program prior to the randomized controlled trial. This phase is intended to identify barriers and facilitators to participation and to inform any refinements to study procedures before proceeding to Phase 2.
Participants assigned to this arm will serve as the comparison group for the randomized controlled trial and will receive an education-based program without active behavioural change targets. This arm is designed to control for attention, expectancy, and self-monitoring effects.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gary Goldfield
Lead Sponsor
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