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Dialectical Behavior Therapy for Youth with Bipolar Disorder (DB1 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
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
Be younger than 65 years old
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 (five years)
Awards & highlights

Summary

This trial will study how well dialectical behavior therapy (DBT) works in adolescents with bipolar disorder over the course of one year. DBT will be delivered in two ways: 1) skills training; and 2) individual therapy sessions. The skills training will cover standard DBT topics like mindfulness, emotion regulation, distress tolerance, interpersonal skills, and walking the middle path skills, plus an additional module on psychoeducation about DBT and BD. The goal of the trial is to improve our understanding of how well DBT works for adolescents with BD, and to identify predictors and mediators of treatment outcomes.

Who is the study for?
This trial is for English-speaking youth aged 13 to nearly 24, who either have bipolar disorder and are on mood stabilizers or have a family history of it. They must be seeing a CAMH psychiatrist regularly and have a history of suicide attempts, self-harm, severe emotional distress, or impulsive behaviors.
What is being tested?
The study tests Dialectical Behavior Therapy (DBT) over one year for young people with or at risk for bipolar disorder. It includes skills training in mindfulness, emotion regulation, distress tolerance, interpersonal effectiveness and psychoeducation about DBT and BD.
What are the potential side effects?
Since DBT is a type of therapy involving talking and skill-building rather than medication, there are no direct physical side effects. However, discussing intense emotions may sometimes feel challenging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with bipolar disorder, or I have a close relative with it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a life-threatening condition that needs immediate treatment.

Timeline

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 family functioning using the Family Adaptability and Cohesion Evaluation Scale, IV (FACES-IV)
+10 more
Secondary study objectives
Change in parental psychological distress using the Symptom Checklist-90 (SCL-90)
Childhood Trust Events Survey (CTES)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Youth with and/or at familial risk for bipolar disorderExperimental Treatment1 Intervention
60 youth aged 13 to 23 with and/or at familial risk for bipolar disorder will be enrolled in the dialectical behavioral therapy intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dialectical behavioral therapy
2019
N/A
~40

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
366 Previous Clinical Trials
82,276 Total Patients Enrolled
15 Trials studying Bipolar Disorder
1,459 Patients Enrolled for Bipolar Disorder
Benjamin I Goldstein, MD, PhDPrincipal InvestigatorCentre for Addiction and Mental Health
5 Previous Clinical Trials
236 Total Patients Enrolled
5 Trials studying Bipolar Disorder
236 Patients Enrolled for Bipolar Disorder

Media Library

Dialectical Behavioral Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05153382 — N/A
Bipolar Disorder Research Study Groups: Youth with and/or at familial risk for bipolar disorder
Bipolar Disorder Clinical Trial 2023: Dialectical Behavioral Therapy Highlights & Side Effects. Trial Name: NCT05153382 — N/A
Dialectical Behavioral Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05153382 — N/A
~25 spots leftby Nov 2026
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