Pragmatic Patient-oriented Extension Study of Dialectical Behavior Therapy Booster Sessions for Youth With and/or at Familial Risk for Bipolar Disorder

What this study is about

The study intervention is DBT adapted for youth with and/or at familial risk for bipolar disorder. Participants will have completed one full year of DBT in a previous study. This study is examining use of booster sessions. It is delivered in the form of individual sessions and skills sessions, based on the preference of the study participant. The study participant may also receive skills coaching via phone. There is no standard reference therapy/comparator against which the study intervention is being compared.

Who can join (things the study team will check)

✅ You may be able to join if…

• Has completed participation in the DB1 study (049-2021) or the DB3 study (009-2021);
• English speaking;
• Age 14 years, 0 months to 26 years, 11 months;
• Meets diagnostic criteria for bipolar disorder 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;
• Followed by a psychiatrist who provides ongoing care;
• If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium);
• Able and willing to give informed consent/assent to participate.

🚫 You may not be able to join if…

• A life-threatening medical condition requiring immediate treatment;
• Current victim of sexual or physical abuse;
• Current substance use disorder other than mild cannabis or alcohol use disorder;
• Evidence of mental retardation, moderate to severe autism spectrum disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records that would interfere with active participation in DBT.

Where this trial is running

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

Who to contact

Vanessa Rajamani, MSW · 416-535-8501 · vanessa.rajamani@camh.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05627492.