12-Month Extension Study of Dialectical Behavior Therapy for Youth With Bipolar Disorder (DB2)

Sunnybrook Health Sciences Centre

Status: Completed

Conditions: Bipolar Disorder

Treatments: Behavioral: Dialectical behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04283188

151/2020 (Other Identifier)

447-2019

Details and patient eligibility

About

The overarching goal of this project is to evaluate the longer-term effects of implementing DBT for adolescents with BD in a subspecialty clinic. In collaboration with the University of Pittsburgh and continuing from the parent study (042-2018), this study will measure the longer-term effects of DBT in additional the the longer-term effects of DBT training on study therapist knowledge and performance.

Full description

This is an extension study related to an ongoing implementation study of dialectical behavior therapy (DBT) for adolescents with bipolar disorder, in collaboration with investigators at the University of Pittsburgh. During the conduct of that initial study (the DITO study; REB PIN 042-2018), compelling questions have been raised by the investigators, study therapists, and participants/patients about what will happen following participation in the initial study: Which DBT outcomes are sustained over time? Will patients request and/or require additional booster sessions? Will study therapists remain adherent to the treatment model? There is sparse knowledge regarding what happens after a course of DBT is completed, and this study seeks to advance our understanding of what happens in the year after DBT by addressing these questions. This study provides a unique opportunity to examine the frequency, dose, and indications for ongoing DBT treatment for participants who have completed one year of DBT at the Centre for Youth Bipolar Disorder (CYBD). In the spirit of the original dissemination and implementation study, this study is focused on "real-world" issues routinely faced by study therapists and patients, and anticipated findings will inform future randomized controlled trials on this topic.

Enrollment: 15 patients

Sex: All

Ages: 14 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English-speaking
• Age 14 years, 0 months to 21 years, 11 months
• Meet diagnostic criteria for BD by KSADS-PL
• Followed by a CAMH or Sunnybrook psychiatrist who provides ongoing care
• If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium
• Has completed participation in the DITO study (REB PIN 042-2018)
• Able and willing to give informed consent/assent to participate.

Exclusion criteria

• Evidence of mental retardation, moderate to severe pervasive developmental disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records
• A life-threatening medical condition requiring immediate treatment
• Current victim of sexual or physical abuse.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Adolescents with bipolar disorder

Experimental group

Description:

25 adolescents aged 14 to 21 with bipolar disorder (type I, type II, not otherwise specified/nos) will be enrolled in the dialectical behavioral therapy intervention.

Treatment:

Behavioral: Dialectical behavioral therapy