Clinical trial Recruiting at 1 site Interventional Ages 13 to 23

DBT-informed care for youth with bipolar disorder

Official title: Personalized and Pragmatic Three-level Model of DBT-informed Care for Youth With and/or at Familial Risk for Bipolar Disorder

Run by Centre for Addiction and Mental Health · NCT05153369 · Data updated 2026-11-12

This study is testing a new way to help young people with bipolar disorder by using different levels of therapy based on their individual needs to see if it improves their emotional health and safety.

Quick facts

Study typeInterventional
Ages13 Years to 23 Years
SexAll
Enrollment60 (estimated)
SponsorCentre for Addiction and Mental Health
Academic / other
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedNovember 1, 2021
Main results expectedMarch 2028
Study endsMarch 2029
Registry record updatedOctober 1, 2026
Trial IDNCT05153369 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are English-speaking youth aged 13 to 23 who meet diagnostic criteria for bipolar disorder or have a familial risk for the condition.

Probably not a fit

Patients with severe cognitive impairments, life-threatening medical conditions, or current substance use disorders may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to address the treatment needs of youth with bipolar disorder (BD) by exploring a multi-level Dialectical Behavior Therapy (DBT)-informed approach. It recognizes that different individuals may require varying intensities of psychosocial interventions, ranging from high-dose to lower-dose treatments. The research will evaluate the feasibility and effectiveness of this adaptive management strategy, which considers risk indicators and symptom severity, particularly focusing on emotional dysregulation and suicidality. By doing so, it seeks to provide a more personalized treatment plan for youth at risk for BD.

Why it matters

Potential benefit: If successful, this approach could lead to more tailored and effective psychosocial treatments for youth with bipolar disorder.

How similar studies have gone: While previous studies have focused on single-level interventions, this multi-level approach is novel and has not been extensively tested in this context.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

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

Study contacts

  • Principal investigator: Benjamin I Goldstein, MD, PhD — Centre for Addiction and Mental Health
  • Study coordinator: Amanda Moss, MSW
  • Email: amanda.moss@camh.ca
  • Phone: 416-535-8501

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.