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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Bipolar disorder (BD) in adolescence is associated with poor outcomes, including impaired psychosocial functioning, substance use, and suicidality. Preliminary data using DBT as a treatment for youth BD shows improvement in depression symptoms and suicidality. At the same time, the reality is that BD is a chronic disease, and it stands to reason that a pragmatic, adaptive management approach is warranted. Developing a multi-level DBT-informed approach is advantageous for a number of reasons, in particular because this approach embraces clinical heterogeneity within and between individuals. Whereas some youth clearly require full/"high-dose" treatment, others may benefit from judicious use of "lower-dose" interventions, alongside re-evaluation of dosing needs over time. Furthermore, there is a subset of youth who do not require and/or do not want the intensity and frequency of treatment that current interventions provide. Thus far, the leading evidence-based psychosocial treatment studies in the field of youth BD have taken an "all or nothing" approach and have only been studied at one dosing level. While such an approach has certain advantages, it lacks person-centered consideration regarding pragmatic dosing. This study endeavors to determine the feasibility and effectiveness of a multi-level treatment model with dosing decisions driven by a combination of risk indicators and symptom severity (with an emphasis on emotional dysregulation, suicidality, and functional impairment; key treatment targets in dialectical behavior therapy), along with patient preference. This study proposes to implement three intensity levels of dialectical behavior therapy (DBT)-informed intervention that differ in regards to the number and frequency of sessions, parental involvement, and treatment components. This research will seek to understand the outcomes of three different levels of therapy and will examine what factors lead to the escalation of DBT dosing levels in this population.

Conditions

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Bipolar Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

This study is targeted toward youth with and/or at familial risk for BD who, at intake, do not want and/or require full DBT. Participants will be enrolled into Level 1 - Enhanced Care or Level 2 - DBT Skills Training; for those whose circumstances change during the course of the study, such that they want and/or require full dose DBT, the intervention also includes potential dose escalation up through Level 3 - DBT Full Intervention. As the levels escalate, frequency of therapy sessions and contact with study therapist will increase. Dosing decisions will be driven by a combination of risk indicators and symptom severity, with an emphasis on emotional dysregulation, suicidality, and functional impairment, along with patient preference. Participants who are initially enrolled into Levels 1 or 2 will be able to escalate to Level 3 up until the end of their first year of enrollment. This is to ensure that they will have time to receive one full year of the DBT intervention.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Level 1

At enrollment, participants will be categorized according to the following criteria related to suicidality, emotion dysregulation, risk behaviors, and participant preference: No lifetime suicidal behaviors on the Columbia-Suicide Severity Rating Scale (C-SSRS) AND no active suicidal ideations with method/plan/intent in the past month on the C-SSRS (cannot score 'yes' on items \> 3).

Group Type EXPERIMENTAL

Enhanced Care

Intervention Type BEHAVIORAL

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).

Level 2

At enrollment, participants will be categorized according to the following criteria related to suicidality, emotion dysregulation, risk behaviors, and participant preference: No non-suicidal self-injurious (NSSI) behaviors in the past 3 months on the C-SSRS AND no suicide attempts (actual, interrupted and/or aborted) in the past year on the C-SSRS AND no preparatory act or behavior in the past year as measured by the C-SSRS OR participant preference.

Group Type EXPERIMENTAL

DBT Skills Training

Intervention Type BEHAVIORAL

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.

Level 3

At enrollment, participants will be categorized according to the following criteria related to suicidality, emotion dysregulation, risk behaviors, and participant preference: NSSI behaviors in the past 3 months on the C-SSRS OR at least 1 suicide attempt in the past year (actual, interrupted, and/or aborted) on the C-SSRS OR at least 1 preparatory act or behavior in the past year as measured by the C-SSRS OR Meets youth threshold for at least 2 impulsive behavior categories on question #4 from the Structured Interview for DSM-IV Personality Disorders Borderline Personality Disorder (SIDP-IV) or 1 category is identified as severe OR participant preference during the course of treatment.

Group Type EXPERIMENTAL

Dialectical Behavior Therapy Full Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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).

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1\) English-speaking; 2) Age 13 years, 0 months to 23 years, 11 months; 3) Meet diagnostic criteria for BD by KSADS-PL (\< 20 years of age) or SCID-5-RV (≥ 20 years of age) OR have a biological parent/sibling with BD (type I or II) confirmed via KSADS-PL or SCID-5-RV; 4) If BD-I, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium); 5) Followed by a psychiatrist who provides ongoing care; 6) Able and willing to give informed consent/assent to participate.

Exclusion Criteria

1\) Evidence of mental retardation, moderate to severe autism spectrum disorder, or organic central nervous system disorder by the K-SADS-PL (\< 20 years of age), parent report, medical history, or school records that would interfere with active participation in DBT; 2) A life-threatening medical condition requiring immediate treatment; 3) Current victim of sexual or physical abuse; 4) Current substance use disorder other than mild cannabis or alcohol use disorder; 5) Meets assessment criteria for Level 3 at enrollment.

Minimum Eligible Age

13 Years

Maximum Eligible Age

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Benjamin Goldstein

Director of the Centre for Youth Bipolar Disorder, Clinician-Scientist, Professor of Psychiatry, Pharmacology & Toxicology, and Psychological Clinical Science

Responsibility Role PRINCIPAL_INVESTIGATOR