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NCT05627492
Pragmatic Patient-oriented 12-Month Extension Study of Dialectical Behavior Therapy Booster Sessions for Youth With Bipolar Disorder
Conditions: Bipolar Disorder
Sex: All
Ages: 14 Years – 25 Years
Phase: NA
Enrollment: 120
Sponsor: Centre for Addiction and Mental Health
Location: Canada
Summary
The study intervention is DBT adapted for youth with 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 CriteriaThe participant must meet all of the inclusion criteria to eligible for this clinical trial:Has completed participation in the DB1 study (049-2021) or the DB3 study (009-2021);English speaking;Age 14 years, 0 months to 25 years, 11 months;Meets diagnostic criteria for BD by KSADS-PL;Followed by a CAMH 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.Exclusion CriteriaAn individual who meets any of the following criteria will be excluded from participation in this clinical trial: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.
Source: ClinicalTrials.gov (NCT05627492). StuddyBuddy aggregates publicly available trial information.