Actively Recruiting

Phase Not Applicable
Age: 14Years - 25Years
All Genders
NCT05627492

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

Led by Centre for Addiction and Mental Health · Updated on 2025-11-19

120

Participants Needed

1

Research Sites

316 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 14Years - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Completed participation in the DB1 study (049-2021) or the DB3 study (009-2021)
  • English speaking
  • Aged between 14 years, 0 months and 26 years, 11 months
  • Meets diagnostic criteria for bipolar disorder by KSADS-PL (under 20 years) or SCID-5-RV (20 years or older), or has a biological parent or sibling with bipolar disorder confirmed by KSADS-PL or SCID-5-RV
  • Receiving ongoing care from a psychiatrist
  • If diagnosed with bipolar disorder type I, currently taking at least one mood stabilizing medication such as antimanic anticonvulsant, antipsychotic, or lithium
  • Able and willing to provide informed consent or assent to participate
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centre for Addiction and Mental Health

Toronto, Ontario, Canada, M6J 1H4

Actively Recruiting

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Research Team

V

Vanessa Rajamani, MSW

CONTACT

A

Amanda Moss, MSW

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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