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

NCT05627492 | Recruiting DMC

• 1 other identifier: 099/2022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Total number of DBT sessions used during the study interval measured using the Therapy Tracking Form

  The Therapy Tracking Form will be used to document the date of the therapy session, type of session, session duration, content, and scheduled date for next therapy visit. This form will be completed by the study therapist after each therapy session.

  At the end of study completion (five years)

• Number of unscheduled/expedited DBT sessions that are required measured using the Therapy

  The Therapy Tracking Form will be used to document if the session was a scheduled session or an unscheduled/expedited session. This form will be completed by the study therapist after each therapy session.

  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

  The Therapy Tracking Form will be used to document the reason for the unscheduled/expedited DBT session. This form will be completed by the study therapist after each therapy session.

  At the end of study completion (five years)

Secondary Outcomes (54)

• Adherence score for DBT booster sessions measured using a modified version of the Dialectical Behavior Therapy Adherence Checklist - Individual Therapy

  At the end of study completion (five years)

• Frequencies of specific DBT components (individual sessions, skills session, phone coaching) measured using the Therapy Tracking Form

  At the end of study completion (five years)

• Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder

  12 months to 18 months

• Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder

  18 months to 24 months

• Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)

  12 months to 15 months

Study Arms (1)

Youth with and/or at familial risk for bipolar disorder

EXPERIMENTAL

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.

Behavioral: Dialectical behavioral therapy

Interventions

Dialectical behavioral therapy BEHAVIORAL

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.

Also known as: DBT

Youth with and/or at familial risk for bipolar disorder

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder; Suicide

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Benjamin I Goldstein, MD, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Rajamani, MSW

CONTACT

416-535-8501; vanessa.rajamani@camh.ca

Amanda Moss, MSW

CONTACT

416-535-8501; amanda.moss@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Centre for Youth Bipolar Disorder, Clinician-Scientist, Professor of Psychiatry, Pharmacology & Toxicology, and Psychological Clinical Science

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 25, 2022
• Study Start: November 9, 2022
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

CA (1)