Dialectical behavior therapy for youth at risk for bipolar disorder

Dialectical Behavior Therapy for Youth With and/or at Familial Risk for Bipolar Disorder: Focus on Predictors and Mediators of Treatment Outcomes

This study is testing if dialectical behavior therapy can help young people aged 13 to 23 who are at risk for bipolar disorder learn important skills to manage their emotions and relationships.

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: NCT05153382 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of dialectical behavior therapy (DBT) for youth aged 13 to 23 who are diagnosed with bipolar disorder or have a familial risk for the condition. Over the course of one year, participants will engage in biweekly DBT skills training and individual therapy sessions, focusing on essential skills such as mindfulness, emotion regulation, and interpersonal effectiveness. The study aims to assess predictors and mediators of treatment outcomes, building on previous research conducted by the University of Pittsburgh and Sunnybrook Health Sciences Centre. Trained therapists will deliver the intervention, with family involvement encouraged but not mandatory.

Who should consider this trial

Good fit: Ideal candidates are English-speaking youth aged 13 to 23 with a diagnosis of bipolar disorder or a familial history of the disorder.

Not a fit: Patients who do not meet the age criteria or do not have a diagnosis of bipolar disorder or familial risk may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly improve emotional regulation and coping skills in youth at risk for bipolar disorder, potentially reducing the severity of their symptoms.

How similar studies have performed: Previous studies have shown promise in adapting DBT for youth with bipolar disorder, indicating a potential for success in this approach.

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; 6a) At least 1 suicide attempt in the past year (actual, interrupted, and/or aborted as measured by the C-SSRS) OR at least 1 preparatory act or behavior in the past year as measured by the C-SSRS OR non-suicidal self-injurious (NSSI) behaviors in the past 3 months (as measured by the C-SSRS) -OR- 6b) Meet youth threshold for at least 2 impulsive behavior categories on question #4 from the SIDP-IV or 1 category is identified as severe (through case discussion that will focus on level of risk, persistence, and impairment); 7) 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.

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: Vanessa Rajamani, MSW

Conditions Bipolar Disorder; Youth; Dialectical Behavior Therapy