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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 25
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Canada
Centre for Addiction and Mental Health
RECRUITING
Toronto
Contact Information
Primary
Vanessa Rajamani, MSW
vanessa.rajamani@camh.ca
416-535-8501
Backup
Amanda Moss, MSW
amanda.moss@camh.ca
416-535-8501
Time Frame
Start Date: 2022-11-09
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 120
Treatments
Experimental: Youth with and/or at familial risk for bipolar disorder
120 youth aged 14 to 26 with bipolar disorder (type I, type II, not otherwise specified/NOS via KSADS-PL or SCID-5-RV) OR at high-risk for bipolar disorder (parent or sibling with bipolar disorder type I or II via KSADS-PL or SCID-5-RV) will be enrolled in the dialectical behavioral therapy booster session intervention.
Related Therapeutic Areas
Sponsors
Leads: Centre for Addiction and Mental Health

This content was sourced from clinicaltrials.gov