Bipolar DisorderNCT06672562
Narrative Enhancement and Cognitive Therapy for Self-Stigma in Youth
A study testing Narrative Enhancement and Cognitive Therapy in people with Bipolar Disorder and Multiple Mental Health Conditions, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 29 years
- Conditions the study is for
- Bipolar Disorder, Multiple Mental Health Conditions
- What is being tested?
- Narrative Enhancement and Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteCanada
- Study dates
- 28 Oct 2024to 30 Jun 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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).
Read the 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.
- Being tested
- Narrative Enhancement and Cognitive Therapy, Usual care
- Keywords
- stigma, narrative enhancement and cognitive therapy, youth, comorbidity, self-stigma, mental health disorder
- Medical subject headings
- Bipolar Disorder, Social Stigma, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Enhancement and Cognitive TherapyBehavioural
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.
Usual careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Narrative Enhancement and Cognitive Therapy |
| Treatment as usual | Placebo comparator | No study-specific care will be provided to these participants. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: From study enrollment to 3-month follow up, up to 28 weeks
Secondary outcomes (3)
Was NECT-Y Acceptable to Youth Participants?
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.
Measured: ~ Week 15 (2-hour focus group)
Was NECT-Y Acceptable to Co-Facilitators?
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.
Measured: ~ Week 28 (1-hour interview)
Was NECT-Y Delivered With Fidelity in Relation to the Intervention Manual as Assessed by a Standardized Fidelity Scale?
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.
Measured: From week 1 to week 14 of the NECT-Y intervention, up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start28 Oct 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Toronto, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Responsible party
- Sponsor
- Investigators
- Lisa Hawke, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672562
- Sponsor's protocol ID
- 062/2024
- Status last verified
- Oct 2026
- First submitted
- 1 Nov 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be placed in a local brain health data bank following institutional requirements.
Publications
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.
PubMed 37650493Hawke 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.
PubMed 40010812