NCT05153369 Three-level Model of DBT-informed Care for Youth With and/or at Familial Risk for Bipolar Disorder (DB3)
| NCT ID | NCT05153369 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre for Addiction and Mental Health |
| Condition | Bipolar Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-11-01 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2021-11-01 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study seeks to bridge the knowledge-to-action gap regarding psychosocial treatment "dosing" for youth with and/or at familial risk for bipolar disorder (BD). In psychiatry, pragmatic collaborative decisions between patient and care provider about pharmacological titrations and tapers are common. Less frequently are there considerations made regarding the pragmatic dosing of psychosocial interventions. Whereas some youth clearly require full/"high-dose" treatment, others may benefit from "lower-dose" interventions, alongside re-evaluation of dosing needs over time. Furthermore, there is a subset of youth who do not require or do not want the intensity and frequency of treatment that current interventions provide. This research presents a unique opportunity to better understand different levels of care within a subspecialized outpatient mental health clinic serving youth with and/or at familial risk for BD who vary greatly in terms of risk indicators, type and severity of symptoms, associated distress, and compounding functional impairment.
Eligibility Criteria
Inclusion Criteria: 1\) English-speaking; 2) Age 13 years, 0 months to 23 years, 11 months; 3) Meet diagnostic criteria for BD by KSADS-PL (\< 20 years of age) or SCID-5-RV (≥ 20 years of age) OR have a biological parent/sibling with BD (type I or II) confirmed via KSADS-PL or SCID-5-RV; 4) If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium); 5) Followed by a psychiatrist who provides ongoing care; 6) Able and willing to give informed consent/assent to participate. Exclusion Criteria: 1\) Evidence of mental retardation, moderate to severe autism spectrum disorder, or organic central nervous system disorder by the K-SADS-PL (\< 20 years of age), parent report, medical history, or school records that would interfere with active participation in DBT; 2) A life-threatening medical condition requiring immediate treatment; 3) Current victim of sexual or physical abuse; 4) Current substance use disorder other than mild cannabis or alcohol use disorder; 5) Meets assessment criteria for Level 3 at enrollment.
Contact & Investigator
Benjamin I Goldstein, MD, PhD
PRINCIPAL INVESTIGATOR
Centre for Addiction and Mental Health
Frequently Asked Questions
Who can join the NCT05153369 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 23 Years, studying Bipolar Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05153369 currently recruiting?
Yes, NCT05153369 is actively recruiting participants. Contact the research team at amanda.moss@camh.ca for enrollment information.
Where is the NCT05153369 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05153369 clinical trial?
NCT05153369 is sponsored by Centre for Addiction and Mental Health. The principal investigator is Benjamin I Goldstein, MD, PhD at Centre for Addiction and Mental Health. The trial plans to enroll 60 participants.
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