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Behavioral Intervention

Dialectical Behavior Therapy for Bipolar Disorder (DB2 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

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the use of additional help (booster sessions) for youth with bipolar disorder who have already completed 1 year of Dialectical Behavioral Therapy. Sessions and skills coaching are offered depending on the participant's preference.

Who is the study for?

This trial is for young people aged 14 to nearly 26 who have bipolar disorder or are at risk due to family history. They must have finished a year of DBT in prior studies, be under care by a CAMH psychiatrist, and if they have BD-I, be on mood stabilizers. Participants need to speak English and consent to join.

What is being tested?

The study tests 'booster' sessions of Dialectical Behavior Therapy (DBT) tailored for youth with/at risk for bipolar disorder. It includes individual therapy, skills training based on preference, and optional phone coaching. There's no comparison treatment; the focus is on these extra DBT sessions.

What are the potential side effects?

Since this trial involves psychological therapy rather than medication, typical side effects associated with drugs aren't expected. However, discussing emotional topics can sometimes cause temporary distress or discomfort.

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

Frequencies of different factors/circumstances leading to the need for unscheduled/expedited DBT sessions measured using the Therapy

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

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

Secondary study objectives

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

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

Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Youth with and/or at familial risk for bipolar disorderExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dialectical behavioral therapy

2019

N/A

~40

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