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Narrative Enhancement and Cognitive Therapy for Self-Stigma in Youth

NCT06672562 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-11-04

No results posted yet for this study

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).

Conditions

  • Bipolar Disorder
  • Multiple Mental Health Conditions

Interventions

BEHAVIORAL

Narrative Enhancement and Cognitive Therapy

NECT-Y consists of 14 90-minute sessions over the course of 14 weeks. The intervention combines psychoeducation, cognitive therapy, narrative therapy, goal-setting and peer support. Each group meeting includes educational materials, reflections, and active exercises that participants are guided through to personalize the content to their experiences. Participants will be provided with a workbook which allows them to follow the activities easier.

OTHER

Usual care

Standard usual care. No study-specific care, but participants will be provided with information on community resources and support, and will also be encouraged to speak to their clinician if they are interested in learning about other services.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of Toronto

    collaborator OTHER

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    collaborator OTHER

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Lisa Hawke, PhD · Centre for Addiction and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2025-12-31
Completion
2026-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06672562 on ClinicalTrials.gov