DBT-informed care for youth with bipolar disorder
Personalized and Pragmatic Three-level Model of DBT-informed Care for Youth With and/or at Familial Risk for Bipolar Disorder
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 13 Years to 23 Years |
| Sex | All |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05153369 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe cognitive impairments, life-threatening medical conditions, or current substance use disorders may not benefit from this study.
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 performed: While previous studies have focused on single-level interventions, this multi-level approach is novel and has not been extensively tested in this context.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.