Three-level Model of DBT-informed Care for Youth With and/or at Familial Risk for Bipolar Disorder (DB3)

Summary

This study seeks to bridge the knowledge-to-action gap regarding psychosocial treatment "dosing" for youth with and/or at familial risk for bipolar disorder (BD). In psychiatry, pragmatic collaborative decisions between patient and care provider about pharmacological titrations and tapers are common. Less frequently are there considerations made regarding the pragmatic dosing of psychosocial interventions. Whereas some youth clearly require full/"high-dose" treatment, others may benefit from "lower-dose" interventions, alongside re-evaluation of dosing needs over time. Furthermore, there is a subset of youth who do not require or do not want the intensity and frequency of treatment that current interventions provide. This research presents a unique opportunity to better understand different levels of care within a subspecialized outpatient mental health clinic serving youth with and/or at familial risk for BD who vary greatly in terms of risk indicators, type and severity of symptoms, associated distress, and compounding functional impairment.

Conditions

• Bipolar Disorder

Interventions

BEHAVIORAL

Enhanced Care

Enhanced care aims to educate participants about bipolar disorder using a didactic approach, in addition to teaching and practicing DBT skills in an applied and relevant manner based on the participant's needs. Participants will receive a total of four sessions (approx. 60 minutes in duration), to occur once a month, at a minimum. The content will be split up into psychoeducation (2 sessions) and selected DBT skills (2 sessions). Psychoeducation will be specific to youth bipolar disorder, covering topics such as symptoms of depression and hypo/mania, medications used to treat bipolar disorder, the role of biology and the environment in emotions, and vulnerability and protective factors to emotion dysregulation and mood episodes. The content of skills sessions will be individualized and based on participant needs and goals (e.g., learning and applying skills to optimize their overall functioning, address problem behaviors and/or stressors, and/or maintain commitment to treatment).

BEHAVIORAL

DBT Skills Training

In DBT Skills Training, participants will only receive skills training and can choose to do this individually and/or with their individual family unit by including their parent(s) and/or sibling(s). Participants will receive 20-25 sessions (approx. 60 minutes in duration), to occur at least biweekly. Skills training will include the five standard youth DBT modules: psychoeducation about DBT and bipolar disorder, mindfulness, distress tolerance, emotion regulation, interpersonal effectiveness, and walking the middle path. The primary focus of the skills training is to impart knowledge and acquire and strengthen pragmatic skills to replace dysfunctional behaviors. If participants choose to include their family members, they will be encouraged to coach one another in effective use of skills.

BEHAVIORAL

Dialectical Behavior Therapy Full Intervention

The DBT full intervention is based on Miller et al.'s DBT for suicidal youth, with modifications for youth with BD. DBT will be conducted over 1 year with approximately 40-50 sessions. Sessions will alternate between individual and skills training sessions. Family involvement in skills training will be strongly encouraged, however will be up to the participant to decide. Participants in Level 3 will complete diary cards tailored for this population, assessing daily mood, suicidality, sleep, and medication adherence. Participants will report use of specified DBT skills on the diary card, and individualized treatment goals will be incorporated into the diary card (e.g., alcohol use). In addition, Level 3 will include skills coaching by phone (via phone and/or text). These brief, structured calls and/or texts function to promote skills generalization by helping the participant and any participating family member(s) use skills to achieve goals and solve problems.

Sponsors & Collaborators

• Centre for Addiction and Mental Health

  lead OTHER

Principal Investigators

• Benjamin I Goldstein, MD, PhD · Centre for Addiction and Mental Health

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

13 Years

Max Age

23 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-01

Primary Completion

2026-03-31

Completion

2026-03-31

Countries

• Canada

Study Locations