Recruiting

Dialectical Behavior Therapy

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT05153382

Conditions

Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 13 - 23

Healthy Volunteers: Not accepted

Interventions

Dialectical behavioral therapy

Study Details

Brief summary:

Dialectical behavior therapy (DBT) will be conducted over 1 year in youth with and/or at familial risk for bipolar disorder (BD). DBT will be divided into two modalities: 1) DBT skills training; and 2) DBT individual therapy sessions. Skills training sessions will incorporate the 5 standard adolescent DBT modules: mindfulness skills, emotion regulation skills, distress tolerance skills, interpersonal skills, and walking the middle path skills and an additional module on psychoeducation about DBT and BD. This study seeks to build upon the knowledge base in this area by offering DBT to youth with and/or at familial risk for BD with an emphasis on predictors and mediators of treatment outcomes.

Conditions

Bipolar Disorder

Study ID

NCT05153382

Start date

Nov 1, 2021

Status verified date

Nov, 2025

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 23

Healthy Volunteers: Not accepted

Inclusion Criteria:

1\) English-speaking; 2) Age 13 years, 0 months to 23 years, 11 months; 3) Meet diagnostic criteria for BD 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; 4) If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium); 5) Followed by a psychiatrist who provides ongoing care; 6a) At least 1 suicide attempt in the past year (actual, interrupted, and/or aborted as measured by the C-SSRS) OR at least 1 preparatory act or behavior in the past year as measured by the C-SSRS OR non-suicidal self-injurious (NSSI) behaviors in the past 3 months (as measured by the C-SSRS) -OR- 6b) Meet youth threshold for at least 2 impulsive behavior categories on question #4 from the SIDP-IV or 1 category is identified as severe (through case discussion that will focus on level of risk, persistence, and impairment); 7) Able and willing to give informed consent/assent to participate.

Exclusion Criteria:

1\) Evidence of mental retardation, moderate to severe autism spectrum disorder, or organic central nervous system disorder by the K-SADS-PL (< 20 years of age), parent report, medical history, or school records that would interfere with active participation in DBT; 2) A life-threatening medical condition requiring immediate treatment; 3) Current victim of sexual or physical abuse; 4) Current substance use disorder other than mild cannabis or alcohol use disorder.

Study Design

Enrollment

60 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

60 youth aged 13 to 23 with and/or at familial risk for bipolar disorder will be enrolled in the dialectical behavioral therapy intervention.

Interventions

Dialectical behavioral therapy

DBT will be conducted over 1 year, and divided into two modalities: skills training, conducted in 60 minute biweekly meetings and individual therapy conducted in 60 minute biweekly sessions. Family participation in skills training is highly encouraged. Skills training proceeds as follows: 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, whereby the individual therapist selects behaviors to focus on based on the following priorities: 1) decreasing life-threatening behaviors, 2) decreasing therapy-interfering behaviors, 3) decreasing quality-of-life interfering behaviors, and 4) increasing behavioral skills. Therapists will be available to participants by cell phone for in-vivo skills coaching between sessions.

Primary outcome measure

  • Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder [ Time Frame: Baseline to 6 months ]
  • Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder [ Time Frame: 6 months to 12 months ]
  • Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: Baseline to 3 months ]
  • Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: 3 months to 6 months ]
  • Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: 6 months to 9 months ]
  • Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [ Time Frame: 9 months to 12 months ]
  • Change in suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: Baseline to 3 months ]
  • Change in suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: 3 months to 6 months ]
  • Change in suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: 6 months to 9 months ]
  • Change in suicidality using the Suicidal Ideation Questionnaire (SIQ) [ Time Frame: 9 months to 12 months ]
  • Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE) [ Time Frame: Baseline to 6 months ]
  • Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE) [ Time Frame: 6 months to 12 months ]
  • Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline to 6 months ]
  • Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 6 months to 12 months ]
  • Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: Baseline to 3 months ]
  • Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 3 months to 6 months ]
  • Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 6 months to 9 months ]
  • Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 9 months to 12 months ]
  • Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 3 months ]
  • Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 6 months ]
  • Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 9 months ]
  • Treatment Satisfaction Questionnaire (18-item) [ Time Frame: 12 months ]
  • Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: Baseline to 3 months ]
  • Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: 3 months to 6 months ]
  • Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: 6 months to 9 months ]
  • Change in affective lability using the Children's Affective Lability Scale (CALS) [ Time Frame: 9 months to 12 months ]
  • Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: Baseline to 3 months ]
  • Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: 3 months to 6 months ]
  • Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: 6 months to 9 months ]
  • Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL) [ Time Frame: 9 months to 12 months ]
  • Change in functioning using the Children's Global Assessment Scale (C-GAS) or Global Assessment of Functioning (GAF) [ Time Frame: Baseline to 6 months ]
  • Change in functioning using the Children's Global Assessment Scale (C-GAS) or Global Assessment of Functioning (GAF) [ Time Frame: 6 months to 12 months ]
  • Change in temperament using the Conflict Behavior Questionnaire (CBQ) [ Time Frame: Baseline to 3 months ]
  • Change in temperament using the Conflict Behavior Questionnaire (CBQ) [ Time Frame: 3 months to 6 months ]
  • Change in temperament using the Conflict Behavior Questionnaire (CBQ) [ Time Frame: 6 months to 9 months ]
  • Change in temperament using the Conflict Behavior Questionnaire (CBQ) [ Time Frame: 9 months to 12 months ]
  • Change in family functioning using the Family Adaptability and Cohesion Evaluation Scale, IV (FACES-IV) [ Time Frame: Baseline to 3 months ]
  • Change in family functioning using the Family Adaptability and Cohesion Evaluation Scale, IV (FACES-IV) [ Time Frame: 3 months to 6 months ]
  • Change in family functioning using the Family Adaptability and Cohesion Evaluation Scale, IV (FACES-IV) [ Time Frame: 6 months to 9 months ]
  • Change in family functioning using the Family Adaptability and Cohesion Evaluation Scale, IV (FACES-IV) [ Time Frame: 9 months to 12 months ]
  • Number, frequency, and type of therapy sessions [ Time Frame: At the end of study completion (five years) ]

Central Contacts and Locations

Central contacts

Vanessa Rajamani, MSW

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

Amanda Moss, MSW

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

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J 1H4

Contacts

Vanessa Rajamani, MSW

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

Amanda Moss, MSW

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

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)

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.