NCT05627492Recruiting
Pragmatic Patient-oriented Extension Study of Dialectical Behavior Therapy Booster Sessions for Youth With and/or at Familial Risk for Bipolar Disorder
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 17 Nov 2022
- Start date
- 9 Nov 2022
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- Centre for Addiction and Mental Health
- Diseases
- Bipolar disorder
- NCT number
- NCT05627492
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 9 Nov 2022 to the primary completion date, 30 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A life-threatening medical condition requiring immediate treatment;
- 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.
Other
- An individual who meets any of the following criteria will be excluded from participation in this clinical trial:
- Current victim of sexual or physical abuse;
Who the study is looking for
- 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.
Age in the registry: 14 years to 25 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Addiction and Mental Health Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.