Recruiting

Dialectical Behavior Therapy

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT05627492

Conditions

Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 14 - 25

Healthy Volunteers: Not accepted

Interventions

Dialectical behavioral therapy

Study Details

Brief 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.

Conditions

Bipolar Disorder

Study ID

NCT05627492

Start date

Nov 9, 2022

Status verified date

Nov, 2025

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria

The participant must meet all of the inclusion criteria to eligible for this clinical trial:

1. Has completed participation in the DB1 study (049-2021) or the DB3 study (009-2021);
2. English speaking;
3. Age 14 years, 0 months to 26 years, 11 months;
4. 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;
5. Followed by a psychiatrist who provides ongoing care;
6. If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium);
7. 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:

1. A life-threatening medical condition requiring immediate treatment;
2. Current victim of sexual or physical abuse;
3. Current substance use disorder other than mild cannabis or alcohol use disorder;
4. 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.

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Dialectical behavioral therapy

DBT will be conducted over 2 years. Participants and their treatment providers will decide on the frequency of sessions collaboratively. This may include individual and/or skills sessions in addition to phone coaching for those who attend individual sessions at least once per month. DBT consultation will also remain a component of the treatment. Participants may choose skills training, conducted in approximately 60 minute meetings, and individual therapy conducted in approximately 60 minute sessions. Family participation in skills training is highly encouraged. Skills training may include: psychoeducation, mindfulness skills, emotion regulation skills, distress tolerance skills, interpersonal skills, and walking the middle path skills. Individual therapy sessions aim to aid the youth in applying skills in their daily lives. We adopt the standard DBT hierarchy of treatment targets.

Primary outcome measure

  • Total number of DBT sessions used during the study interval measured using the Therapy Tracking Form [ Time Frame: At the end of study completion (five years) ]
  • Number of unscheduled/expedited DBT sessions that are required measured using the Therapy [ Time Frame: At the end of study completion (five years) ]
  • Frequencies of different factors/circumstances leading to the need for unscheduled/expedited DBT sessions measured using the Therapy [ Time Frame: At the end of study completion (five years) ]

Central Contacts and Locations

Central contacts

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J 1H4

Contacts

Principal Investigator:

Benjamin I Goldstein, MD, PhD

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Nov 19, 2025

Last verified

Nov, 2025

Keywords

  • Youth
  • Dialectical Behavior Therapy (DBT)
  • Suicide
  • Psychotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2025-11-19.