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

NCT ID: NCT04283188

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-19
• Study Completion Date: 2023-01-13

Brief Summary

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.

Detailed 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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adolescents with bipolar disorder

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.

Group Type: EXPERIMENTAL

Dialectical behavioral therapy

Intervention Type: BEHAVIORAL

Participants will be provided with the option to continue treatment with their study therapist. For those who elect to continue with DBT sessions, they will discuss frequency of sessions with their therapist, in addition to selecting type of sessions (individual and/or family skills). Participants who elect not to continue with DBT sessions at the time of enrollment will retain the option of being able to request additional sessions at any point during the 12-month study. Irrespective of participation in additional DBT sessions, all participants will be asked to complete follow-up interviews and questionnaires.

Interventions

Dialectical behavioral therapy

Participants will be provided with the option to continue treatment with their study therapist. For those who elect to continue with DBT sessions, they will discuss frequency of sessions with their therapist, in addition to selecting type of sessions (individual and/or family skills). Participants who elect not to continue with DBT sessions at the time of enrollment will retain the option of being able to request additional sessions at any point during the 12-month study. Irrespective of participation in additional DBT sessions, all participants will be asked to complete follow-up interviews and questionnaires.

Intervention Type: BEHAVIORAL

Other Intervention Names

DBT

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Benjamin Goldstein

Director of the Centre for Youth Bipolar Disorder, Senior Scientist, Psychiatrist, Principal Investigator, Professor of Psychiatry, Pharmacology & Toxicology, and Psychological Clinical Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin I Goldstein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Research Insitute

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

151/2020

Identifier Type: OTHER

Identifier Source: secondary_id

447-2019

Identifier Type: -

Identifier Source: org_study_id