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

NCT03661333 | Completed DMC

• 1 other identifier: 042-2018
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

dialectical behavior therapy

Outcome Measures

Primary Outcomes (6)

• Therapist satisfaction and acceptability

  Therapists will complete a questionnaire (Therapist Satisfaction and Acceptability Questionnaire) assessing their satisfaction with the training and treatment approach at 6 months. Acceptability will be defined as mean acceptability ratings \> 5 ("acceptable") on a likert scale from 1 ("very unacceptable") to 7 ("very acceptable").

  Baseline

• Therapist satisfaction and acceptability

  Therapists will complete a questionnaire (Therapist Satisfaction and Acceptability Questionnaire) assessing their satisfaction with the training and treatment approach at 6 months. Acceptability will be defined as mean acceptability ratings \> 5 ("acceptable") on a likert scale from 1 ("very unacceptable") to 7 ("very acceptable").

  6 months

• therapists will adhere to the DBT Adherence Rating Scale

  Tapes will be rated for adherence using the DBT Adherence Rating scale. The scale generates a Global Score of DBT adherence and subscale scores for the 12 DBT strategy domains. To examine sustained adherence, each therapist will submit 3 consecutive sessions for adherence coding. The rating scale is not available to the public and is utilized by the DBT-Linehan Board of Certification (copyright). Please see http://www.dbt-lbc.org/downloads/Applicant\_Handbook\_final\_with\_RW\_review\_2018.pdf for more information.

  End of study year 2

• Therapists will obtain a passing grade of the DBT Certification Exam

  Clinicians will attain knowledge and fidelity required to pass the DBT certification examination (exam total score ≥ 80%; passing score on case conceptualization; two of three consecutive tapes coded at or above adherence). Please see the certification manual http://www.dbt-lbc.org/downloads/Applicant\_Handbook\_final\_with\_RW\_review\_2018.pdf for more information.

  1 year

• Therapist satisfaction and acceptability

  Therapists will complete a questionnaire (Therapist Satisfaction and Acceptability Questionnaire) assessing their satisfaction with the training and treatment approach at 12 months. Acceptability will be defined as mean acceptability ratings \> 5 ("acceptable") on a likert scale from 1 ("very unacceptable") to 7 ("very acceptable").

  12 months

• Therapist satisfaction and acceptability

  Therapists will complete a questionnaire (Therapist Satisfaction and Acceptability Questionnaire) assessing their satisfaction with the training and treatment approach at 24 months. Acceptability will be defined as mean acceptability ratings \> 5 ("acceptable") on a likert scale from 1 ("very unacceptable") to 7 ("very acceptable").

  24 months

Secondary Outcomes (42)

• Change in symptoms using the Longitudinal Interval Follow-up Evaluation (LIFE)

  Baseline to 6 months

• Change in symptoms using the Longitudinal Interval Follow-up Evaluation (LIFE)

  6 months to 12 months

• Schedule for Affective Disorders and Schizophrenia for School Age Children, Present and Life Version (K-SADS-PL)

  Baseline

• K-SADS Mania Rating Scale (MRS)

  Baseline

• Depression section of the K-SADS-Present Episode Version (K-SADS-Dep)

  Baseline

Study Arms (1)

Adolescents with bipolar disorder

EXPERIMENTAL

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.

Behavioral: Dialectical behavioral therapy

Interventions

Dialectical behavioral therapy 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.

Also known as: DBT

Adolescents with bipolar disorder

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• University of Pittsburgh: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Benjamin I Goldstein, MD, PhD

  Sunnybrook Research Insitute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist, Psychiatrist

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 7, 2018
• Study Start: January 31, 2019
• Primary Completion: November 8, 2021
• Study Completion: November 8, 2021
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)