Booster sessions of Dialectical Behavior Therapy for youth at risk for bipolar disorder

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

This study is testing if extra Dialectical Behavior Therapy sessions can help young people who are at risk for bipolar disorder stay on track after finishing a full year of therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 14 Years to 25 Years
• Sex: All
• Sponsor: Centre for Addiction and Mental Health (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT05627492 on ClinicalTrials.gov

What this trial studies

This study focuses on providing booster sessions of Dialectical Behavior Therapy (DBT) for youth who have previously completed a full year of DBT and are at risk for bipolar disorder. Participants will have the flexibility to choose the frequency and type of sessions, including individual therapy and skills coaching via phone, based on their preferences and in consultation with their treatment providers. The aim is to support ongoing care while promoting autonomy in treatment decisions. The intervention is designed to be less intensive, recognizing the prior completion of a full DBT program.

Who should consider this trial

Good fit: Ideal candidates are youth aged 14 to 26 who have completed a year of DBT and either meet the diagnostic criteria for bipolar disorder or have a family history of the condition.

Not a fit: Patients with life-threatening medical conditions, current abuse situations, or substance use disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the long-term management of bipolar disorder in youth, potentially reducing symptoms and improving overall mental health outcomes.

How similar studies have performed: While this specific approach is novel, previous studies have shown the effectiveness of DBT in managing symptoms of bipolar disorder, suggesting potential for success in this adapted format.

Eligibility criteria

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.

Where this trial is running

Toronto, Ontario

• Centre for Addiction and Mental Health — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Benjamin I Goldstein, MD, PhD — Centre for Addiction and Mental Health
• Study coordinator: Vanessa Rajamani, MSW

Conditions Bipolar Disorder; Youth; Dialectical Behavior Therapy; Suicide; Psychotherapy