Dissemination and Implementation Field Trial of Dialectical Behavior Therapy for Adolescents With Bipolar Disorder

NCT ID: NCT03661333

Last Updated: 2021-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2021-11-08

Brief Summary

The overarching goal of this project is to evaluate the feasibility of implementing dialectical behavior therapy DBT for adolescents with bipolar disorder in an outpatient mental health clinic. In collaboration with the University of Pittsburgh, this study will measure study therapists' knowledge of the DBT model, adherence to the treatment model, and satisfaction with the treatment model.

Detailed Description

This study proposes to implement dialectical behavior therapy (DBT) for adolescents with bipolar disorder (BD) in an outpatient mental health clinic serving youth with bipolar spectrum disorders. In collaboration with the University of Pittsburgh, this study will systemically operationalize, implement, and examine the specific training, supervision, and programmatic systems needed to successfully implement and sustain the intervention in an adherent manner to achieve positive patient outcomes. This study therefore presents a unique opportunity to enhance understanding of the necessary procedures for implementing the treatment in the community, while allowing us to examine effectiveness of the intervention at the community level.

Aim 1: To examine the short- and longer-term feasibility and acceptability of a training program in DBT for adolescents with BD through clinician satisfaction ratings.

Aim 2: To examine the short- and longer-term effects of the training on practitioner knowledge and performance, and patient outcomes.

Conditions

Bipolar Disorder

Keywords

dialectical behavior therapy

Study Design

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

Study Groups

Adolescents with bipolar disorder

40 adolescents aged 13 to 19 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

DBT will be conducted over 1 year, and divided into two modalities: skills training, conducted in 60 minute biweekly family meetings and individual therapy conducted in 60 minute biweekly sessions. Family skills training proceeds as follows: psychoeducation about DBT and bipolar disorder, mindfulness skills, emotion regulation skills, distress tolerance skills, interpersonal skills, and walking the middle path skills. Individual therapy sessions aim to aid the adolescent in applying skills in their daily lives. We adopt the standard DBT hierarchy of treatment targets, whereby the individual therapist selects behaviors to focus on based on the following priorities: 1) decreasing life-threatening behaviors, 2) decreasing therapy-interfering behaviors, 3) decreasing quality-of-life interfering behaviors, and 4) increasing behavioral skills. Therapists will be available to participants and their participating family members by cell phone for in-vivo skills coaching between sessions.

Interventions

Dialectical behavioral therapy

DBT will be conducted over 1 year, and divided into two modalities: skills training, conducted in 60 minute biweekly family meetings and individual therapy conducted in 60 minute biweekly sessions. Family skills training proceeds as follows: psychoeducation about DBT and bipolar disorder, mindfulness skills, emotion regulation skills, distress tolerance skills, interpersonal skills, and walking the middle path skills. Individual therapy sessions aim to aid the adolescent in applying skills in their daily lives. We adopt the standard DBT hierarchy of treatment targets, whereby the individual therapist selects behaviors to focus on based on the following priorities: 1) decreasing life-threatening behaviors, 2) decreasing therapy-interfering behaviors, 3) decreasing quality-of-life interfering behaviors, and 4) increasing behavioral skills. Therapists will be available to participants and their participating family members by cell phone for in-vivo skills coaching between sessions.

Intervention Type: BEHAVIORAL

Other Intervention Names

DBT

Eligibility Criteria

Inclusion Criteria

• English-speaking
• Age 13 years, 0 months to 19 years, 11 months
• Meet diagnostic criteria for BD by KSADS-PL
• Engaged in, or willing to proceed with, a pharmacotherapy regimen
• At least one parent/guardian with whom the patient lives or regularly interacts (>5 hours per week) is willing to participate in skills training
• 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: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Benjamin Goldstein

Senior Scientist, Psychiatrist

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

Countries

Canada

Other Identifiers

042-2018

Identifier Type: -

Identifier Source: org_study_id