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Behavioral Intervention

DBT-informed Care for Bipolar Disorder (DB3 Trial)

N/A

Recruiting

Led By Benjamin I Goldstein, MD, PhD

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium)

Meet diagnostic criteria for BD by KSADS-PL OR have a biological parent/sibling with BD (type I or II) confirmed via KSADS-PL or SCID-5-RV

Must not have

A life-threatening medical condition requiring immediate treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of study completion (5 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how different "doses" of psychosocial treatment affect youth with bipolar disorder.

Who is the study for?

This trial is for English-speaking youth aged 13 to almost 24 with bipolar disorder. Participants must be diagnosed by KSADS-PL, and if they have Bipolar I, they should be on mood stabilizing medication. They need ongoing care from a CAMH psychiatrist and must consent to join the study. It's not for those with certain developmental disorders, current abuse victims, life-threatening conditions, or severe substance use issues.

What is being tested?

The study tests different 'doses' of psychosocial treatments in youths at risk for or with bipolar disorder: Enhanced Care (low dose), Full Dialectical Behavior Therapy (high dose), and DBT Skills Training (medium dose). The goal is to find out which level of intervention works best depending on individual needs.

What are the potential side effects?

Since this trial focuses on psychosocial interventions rather than medications, traditional side effects are not the main concern. However, participants may experience emotional discomfort or distress during therapy sessions as sensitive topics are discussed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am taking medication to stabilize my mood for bipolar disorder.

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I have been diagnosed with bipolar disorder or have a close relative with it.

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I am between 13 and 23 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious health issue that needs urgent treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of study completion (five years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of study completion (five years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of study completion (five years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in affective lability using the Children's Affective Lability Scale (CALS)

Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)

Change in suicidality Suicidal Ideation Questionnaire (SIQ)

+9 more

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Level 3Experimental Treatment1 Intervention

At enrollment, participants will be categorized according to the following criteria related to suicidality, emotion dysregulation, risk behaviors, and participant preference: NSSI behaviors in the past 3 months on the C-SSRS OR at least 1 suicide attempt in the past year (actual, interrupted, and/or aborted) on the C-SSRS OR at least 1 preparatory act or behavior in the past year as measured by the C-SSRS OR Meets youth threshold for at least 2 impulsive behavior categories on question #4 from the Structured Interview for DSM-IV Personality Disorders Borderline Personality Disorder (SIDP-IV) or 1 category is identified as severe OR participant preference during the course of treatment.

Group II: Level 2Experimental Treatment1 Intervention

At enrollment, participants will be categorized according to the following criteria related to suicidality, emotion dysregulation, risk behaviors, and participant preference: No non-suicidal self-injurious (NSSI) behaviors in the past 3 months on the C-SSRS AND no suicide attempts (actual, interrupted and/or aborted) in the past year on the C-SSRS AND no preparatory act or behavior in the past year as measured by the C-SSRS OR participant preference.

Group III: Level 1Experimental Treatment1 Intervention

At enrollment, participants will be categorized according to the following criteria related to suicidality, emotion dysregulation, risk behaviors, and participant preference: No lifetime suicidal behaviors on the Columbia-Suicide Severity Rating Scale (C-SSRS) AND no active suicidal ideations with method/plan/intent in the past month on the C-SSRS (cannot score 'yes' on items \> 3).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enhanced Care

2010

Completed Phase 4

~1320

DBT Skills Training

2015

N/A

~40