Narrative Enhancement and Cognitive Therapy for Self-Stigma in Youth

May 13, 2026 updated by: Centre for Addiction and Mental Health

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this pilot basket randomized controlled trial (RCT) is to assess the feasibility of conducting a full-scale study to learn if a youth-adapted Narrative Enhancement and Cognitive Therapy (NECT-Y) can reduce self-stigma in youth diagnosed with bipolar disorder (BD) or with multiple mental health conditions (MMHC). More specifically, this trial has three objectives: 1) to assess whether it is feasible to run a definitive RCT of the new NECT-Y intervention, 2) to explore the facilitators' ability to deliver the new intervention with fidelity, and 3) to assess whether the newly adapted version is acceptable to participants and facilitators, including barriers/facilitators to using NECT-Y.

This parallel-arm pilot basket RCT will be conducted to compare NECT-Y to Treatment as Usual (TAU). The two-arm, pilot RCT will be conducted as two samples within a single basket trial and will include 48 participants with BD and 48 participants with MMHC for a total of approx. 96 participants. Participants will be 1:1 randomized to receive NECT-Y (n=48) or TAU (n=48). Five facilitators, including peer co-facilitators, have been recruited and trained to deliver the intervention.

Participants with BD will be recruited from a clinical pool from outpatient hospital clinics in Toronto (CAMH) and London (LHSC), Ontario, as well as from other CAMH studies if they have provided consent to be re-contacted. Participants with MMHC will be recruited from CAMH only, from among participants recruited to other studies and who have consented to be contacted about additional research opportunities. All participants will follow the same study design. Participants will be screened sequentially during the recruitment period, until the sample size is reached. Eligible participants will complete baseline assessments and then be subsequently randomized to NECT-Y for 14 weeks or TAU. The NECT-Y intervention will be delivered virtually to ≈12 participants/group, with the same number of control participants assigned to TAU. TAU 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. No study-specific care will be provided to TAU participants. NECT-Y and TAU participants will complete post-treatment assessments after 14 weeks, and again at 3 months follow up. To understand the acceptability of the intervention, qualitative focus groups (approx. 2 hours) will be conducted by the research staff with NECT-Y participants (who consent), and individual interviews will be conducted with the NECT-Y facilitators and peer co-facilitators. Participants randomized to TAU will not receive NECT-Y after the 14-week period as this is beyond the scope of this pilot trial.

This is a youth-engaged mixed methods pilot acceptability and feasibility RCT, with the qualitative component embedded at the post-treatment follow-up stage. Evaluation will include baseline, post-treatment, and 3-month follow-up, feasibility metrics, interpreted together with the themes generated from qualitative focus groups/interviews conducted with participants and facilitators. Lived experience team members will be involved in all stages, from study design to knowledge translation, as co-investigators and a youth advisory group.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6J1H4
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Mental health-related hospitalization or emergency department visit in the last 30 days
  • Initiation of a new psychotherapy in the last 30 days
  • Inability to consent or to communicate in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Placebo Comparator: Treatment as usual
No study-specific care will be provided to these participants.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Providing Consent to Participate in the Study
Time Frame: Duration of the study enrollment period, up to 1 year
Our study target is > 60% of individuals approached/contacted will consent to participate in the study.
Duration of the study enrollment period, up to 1 year
Number of Participants Providing Consent in Two Months
Time Frame: Duration of the study enrollment period, up to 1 year
The study target is to obtain study consent from 24 participants in two months.
Duration of the study enrollment period, up to 1 year
Number of Sessions Attended by Participants Randomized to NECT-Y
Time Frame: From week 1 to week 14 of the NECT-Y intervention, up to 14 weeks
The study target is that participants randomized to NECT-Y attend > 80% of the 14 sessions.
From week 1 to week 14 of the NECT-Y intervention, up to 14 weeks
Number of Participants Completing Study Questionnaires at Week 15
Time Frame: Week 15 (post-treatment)
The study target is > 80% of the participants complete at least one questionnaire at post-treatment (week 15).
Week 15 (post-treatment)
Number of Participants Completing Study Questionnaires at Week 28
Time Frame: Week 28 (3-month follow up)
The study target is > 80% of the participants complete at least one questionnaire at 3-month follow up (week 28).
Week 28 (3-month follow up)
Number of Questionnaires Completed at Week 15
Time Frame: Week 15 (post-treatment)
The study target is participants complete > 90% of the 14 questionnaires at post-treatment (week 15).
Week 15 (post-treatment)
Number of Questionnaires Completed at Week 28
Time Frame: Week 28 (3-month follow up)
The study target is participants complete > 90% of the 14 questionnaires at 3-month follow up (week 28).
Week 28 (3-month follow up)
Number of Participants With Study-Related Adverse Events as Assessed by an Institutional Adverse Event Log
Time Frame: From study enrollment to 3-month follow up, up to 28 weeks
The study target is for their to be no adverse events throughout a participants enrollment in the study, including no AEs from participating in the NECT-Y intervention. AEs will be tracked ad hoc as participants self-report any AEs.
From study enrollment to 3-month follow up, up to 28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Was NECT-Y Acceptable to Youth Participants?
Time Frame: ~ Week 15 (2-hour focus group)
Qualitative measure assessed in focus groups. Individuals will be asked to comment on their experience receiving NECT-Y, their impressions of the youth adaptation, and whether it was an appropriate intervention.
~ Week 15 (2-hour focus group)
Was NECT-Y Acceptable to Co-Facilitators?
Time Frame: ~ Week 28 (1-hour interview)
Qualitative measure assessed in qualitative interviews. Individuals will be asked to comment on their experience facilitating NECT-Y, their impressions of the youth adaptation, and whether it was an appropriate intervention.
~ Week 28 (1-hour interview)
Was NECT-Y Delivered With Fidelity in Relation to the Intervention Manual as Assessed by a Standardized Fidelity Scale?
Time Frame: From week 1 to week 14 of the NECT-Y intervention, up to 14 weeks
Scale: NECT Fidelity Scale; 8-item scale, minimum value 1 (Poor), maximum value 5 (Excellent). Higher scores indicate greater fidelity in how the group facilitators delivered NECT-Y as intended based on the intervention manual. Conducted for each NECT-Y group. Sessions will be audio-recorded and rated. Two trained staff will code the recordings, and inter-rated reliability will be calculated and fidelity scores computed. Target is a mean overall fidelity rating of 4 on a 5-point scale.
From week 1 to week 14 of the NECT-Y intervention, up to 14 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in the Mean Self-Stigma at Week 15 (post-treatment)
Time Frame: baseline, 15 weeks
Scale: Internalized Stigma of Mental Illness Inventory; 29 item scale, minimum value for each item = 0 (Strongly disagree), maximum value = 3 (Strongly agree). Higher scores indicate more severe self-stigma.
baseline, 15 weeks
Change from Baseline in the Mean Self-Stigma at Week 28 (3-Months Follow-up)
Time Frame: baseline, 28 weeks
Scale: Internalized Stigma of Mental Illness Inventory; minimum value for each item = 0 (Strongly disagree), maximum value = 3 (Strongly agree). Higher scores indicate more severe self-stigma.
baseline, 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Collaborators

Canadian Institutes of Health Research (CIHR)
University of Toronto
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Investigators

  • Principal Investigator: Lisa Hawke, PhD, Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 1, 2024

First Submitted That Met QC Criteria

November 1, 2024

First Posted (Actual)

November 4, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 062/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be placed in a local brain health data bank following institutional requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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