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Recruiting NCT05627492

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

Trial Parameters

Condition Bipolar Disorder
Sponsor Centre for Addiction and Mental Health
Study Type INTERVENTIONAL
Phase N/A
Enrollment 120
Sex ALL
Min Age 14 Years
Max Age 25 Years
Start Date 2022-11-09
Completion 2028-11-30
Interventions
Dialectical behavioral therapy

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria The participant must meet all of the inclusion criteria to eligible for this clinical trial: 1. Has completed participation in the DB1 study (049-2021) or the DB3 study (009-2021); 2. English speaking; 3. Age 14 years, 0 months to 26 years, 11 months; 4. 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; 5. Followed by a psychiatrist who provides ongoing care; 6. If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium); 7. Able and willing to give informed consent/assent to participate. Exclusion Criteria An individual who meets any of the following criteria will be excluded from participation in this clinical trial: 1. A life-threatening medical condition requiring immediate treatment; 2. Current victim of sexual or physical abuse; 3. Current substance use di

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