Clinical trials

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.

This two-phase, double-blind, balanced, parallel-group randomized controlled trial evaluates the feasibility, usability, engagement, and clinical impact of an app-based adaptation of the Mindfulness-Based Eating Awareness Training (MB-EAT) program for adolescents living with obesity. MB-EAT, has been shown to reduce binge eating episodes, improve food-related self-control, and decrease depressive symptoms in adults with obesity. The app based program promotes mindful awareness and self-regulation in response to hunger and satiety cues, without caloric restriction. Youth aged 12-17.5 years who are waitlisted or have recently been waitlisted for treatment at the Centre for Healthy Active Living (CHAL) at the Children's Hospital of Eastern Ontario (CHEO) will be enrolled in a 4-week app-based MB-EAT program (Phase 1, n=10) to evaluate feasibility, usability, and engagement. Phase 2 is a 12-week randomized controlled trial with 160 participants who will be randomized to the experimental arm (app-based MB-EAT program; 60-90 minutes/week) or an active comparator arm (app-based psychoeducation) to evaluate whether the MB-EAT program improves disinhibited eating. At the end of the intervention, 20 participants will be randomly selected for interviews to explore their experiences with the app. Additional secondary outcomes in Phase 2 include depressive symptoms, anxiety symptoms, emotion regulation, dispositional mindfulness, food craving, mindful eating, body image, health-related quality of life, impact of weight on quality of life, internalized weight bias, food impulsivity, and food reinforcement.