RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Centre for Addiction and Mental Health • ClinicalTrials.gov ID: NCT05627492

Registry updated: 2026-10-01

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Description

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.

Interventions

Dialectical behavioral therapy (Behavioral)
DBT will be conducted over 1 year. Participants and their treatment providers will decide on the frequency of sessions collaboratively. This may include individual and/or skills sessions in addition to phone coaching for those who attend individual sessions at least once per month. DBT consultation will also remain a component of the treatment. Participants may choose skills training, conducted in approximately 60 minute meetings, and individual therapy conducted in approximately 60 minute sessions. Family participation in skills training is highly encouraged. Skills training may include: psychoeducation, mindfulness skills, emotion regulation skills, distress tolerance skills, interpersonal skills, and walking the middle path skills. Individual therapy sessions aim to aid the youth in applying skills in their daily lives. We adopt the standard DBT hierarchy of treatment targets.

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 disorder other than mild cannabis or alcohol use disorder; 4. 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.

Conditions

Bipolar Disorder

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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