Pragmatic Patient-oriented Extension Study of Dialectical Behavior Therapy Booster Sessions for Youth With and/or at Familial Risk for Bipolar Disorder
Recruiting · NCT05627492 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre for Addiction and Mental Health
View the official record on ClinicalTrials.gov →Interventions studied
Dialectical behavioral therapy
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.
Who can take part
Age range
14 Years to 25 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- The 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 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.
Exclusion criteria
- An 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;
- 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 it is running
1 location listed.
- Centre for Addiction and Mental Health - Toronto, Ontario, Canada