Narrative Enhancement and Cognitive Therapy for Self-Stigma in Youth

NCT06672562 | Recruiting

• 1 other identifier: 062/2024
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

stigma; narrative enhancement and cognitive therapy; youth; comorbidity; self-stigma; mental health disorder

Outcome Measures

Primary Outcomes (8)

• Number of Participants Providing Consent to Participate in the Study

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (3)

• Was NECT-Y Acceptable to Youth Participants?

  ~ Week 15 (2-hour focus group)

• Was NECT-Y Acceptable to Co-Facilitators?

  ~ Week 28 (1-hour interview)

• Was NECT-Y Delivered With Fidelity in Relation to the Intervention Manual as Assessed by a Standardized Fidelity Scale?

  From week 1 to week 14 of the NECT-Y intervention, up to 14 weeks

Other Outcomes (2)

• Change from Baseline in the Mean Self-Stigma at Week 15 (post-treatment)

  baseline, 15 weeks

• Change from Baseline in the Mean Self-Stigma at Week 28 (3-Months Follow-up)

  baseline, 28 weeks

Study Arms (2)

NECT-Y

EXPERIMENTAL

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

Treatment as usual

PLACEBO COMPARATOR

No study-specific care will be provided to these participants.

Other: Usual care

Interventions

Narrative Enhancement and Cognitive Therapy BEHAVIORAL

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.

NECT-Y

Usual care OTHER

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.

Treatment as usual

Eligibility Criteria

• Age: 16 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• University of Toronto: collaborator
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1H4, Canada

RECRUITING

Related Publications (2)

• Hawke LD, Bennett R, Sheikhan NY, Yanos P. Lived experience adaptation of a psychosocial intervention for young adults with bipolar spectrum disorders: Process description and adaptation outcomes. Early Interv Psychiatry. 2023 Nov;17(11):1125-1130. doi: 10.1111/eip.13461. Epub 2023 Aug 31.

  PMID: 37650493 BACKGROUND

• Hawke LD, Husain MI, Amartey A, Ma C, Osuch E, Yanos PT, Gallagher L, Jordan A, Orson J, Lee A, Kozloff N, Kidd SA, Goldstein BI, Sheikhan NY, Ortiz A, Szatmari P. Narrative enhancement and cognitive therapy for self-stigma among youth with bipolar disorder or multiple mental health conditions: protocol for a pilot randomised basket trial. BMJ Open. 2025 Feb 26;15(2):e096222. doi: 10.1136/bmjopen-2024-096222.

  PMID: 40010812 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Social Stigma; Mental Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lisa Hawke, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Hawke

CONTACT

416-535-8501; Lisa.Hawke@camh.ca

Abigail Amartey, MPH MSW

CONTACT

abigail.amartey@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Data analysts will be masked as to treatment arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: November 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)