A Randomized Pilot Basket Trial of Discovering Our Best Selves: Narrative Enhancement and Cognitive Therapy for Self-stigma Among Youth

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this pilot clinical trial is to assess the feasibility of conducting a full-scale study to learn if a new youth-adapted Narrative Enhancement and Cognitive Therapy (NECT-Y) reduces self-stigma in youth living with bipolar disorder or multiple mental health conditions. The main questions it aims to answer are: * What is the feasibility of conducting a definitive clinical trial in terms of recruitment success, study retention/compliance, treatment retention/compliance, and absence of serious adverse events? * Can facilitators deliver the adapted NECT-Y intervention with fidelity? * What is the acceptability of the newly adapted NECT-Y intervention among youth participants and facilitators? Researchers will compare NECT-Y to treatment as usual (TAU). Participants will take part in a virtual 14-week NECT-Y group intervention or receive TAU. They will also complete questionnaires at three time points (baseline, post-treatment, and follow-up).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 29
Healthy Volunteers: f
View:

• Primary diagnosis of bipolar disorder (any subtype) OR diagnosed with multiple mental health conditions (excluding bipolar disorder)

• 'Mild' to 'severe' internalized stigma (mean score \> 2.0 on the Internalized Stigma of Mental Illness Inventory)

• Must sign and date the informed consent form

• Stated willingness to comply with all study procedures

Locations
Other Locations
Canada
Centre for Addiction and Mental Health
RECRUITING
Toronto
Contact Information
Primary
Lisa Hawke
Lisa.Hawke@camh.ca
416-535-8501
Backup
Abigail Amartey, MPH MSW
abigail.amartey@camh.ca
Time Frame
Start Date: 2024-11
Estimated Completion Date: 2026-04
Participants
Target number of participants: 96
Treatments
Experimental: NECT-Y
Virtual 14-week Narrative Enhancement and Cognitive Therapy group intervention that will be co-facilitated by a clinician and peer support worker.
Placebo_comparator: Treatment as usual
No study-specific care will be provided to these participants.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), University of Toronto, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Leads: Centre for Addiction and Mental Health

This content was sourced from clinicaltrials.gov