Clinical trial NCT05153369: Three-level Model of DBT-informed Care for Youth With and/or at Familial Risk for Bipolar Disorder (DB3)
Official title: Personalized and Pragmatic Three-level Model of DBT-informed Care for Youth With and/or at Familial Risk for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Keywords: Youth
Dialectical Behavior Therapy (DBT)
Psychotherapy
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
timeFrame: Baseline to 6 months
measure: Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
timeFrame: 6 months to 12 months
measure: Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
timeFrame: 12 months to 18 months
measure: Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder
timeFrame: 18 months to 24 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: Baseline to 3 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: 3 months to 6 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: 6 months to 9 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: 9 months to 12 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: 12 months to 15 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: 15 months to 18 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: 18 months to 21 months
measure: Change in symptoms using the Mood and Feelings Questionnaire (MFQ)
timeFrame: 21 months to 24 months
measure: Change in suicidality Suicidal Ideation Questionnaire (SIQ)
timeFrame: Baseline to 3 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 3 months to 6 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 6 months to 9 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 9 months to 12 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 12 months to 15 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 15 months to 18 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 18 months to 21 months
measure: Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)
timeFrame: 21 months to 24 months
measure: Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
timeFrame: Baseline to 6 months
measure: Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
timeFrame: 6 months to 12 months
measure: Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
timeFrame: 12 months to 18 months
measure: Change in symptoms using the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE)
timeFrame: 18 months to 24 months
measure: Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline to 6 months
measure: Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 6 months to 12 months
measure: Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 12 months to 18 months
measure: Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 18 months to 24 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline to 3 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 3 months to 6 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 6 months to 9 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 9 months to 12 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 12 months to 15 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 15 months to 18 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 18 months to 21 months
measure: Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 21 months to 24 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 3 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 6 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 9 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 12 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 15 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 18 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 21 months
measure: Treatment Satisfaction Questionnaire (18-item)
timeFrame: 24 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: Baseline to 3 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: 3 months to 6 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: 6 months to 9 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: 9 months to 12 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: 12 months to 15 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: 15 months to 18 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: 18 months to 21 months
measure: Change in affective lability using the Children's Affective Lability Scale (CALS)
timeFrame: 21 months to 24 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: Baseline to 3 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: 3 months to 6 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: 6 months to 9 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: 9 months to 12 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: 12 months to 15 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: 15 months to 18 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: 18 months to 21 months
measure: Change in use of DBT skills with the DBT Ways of Coping Checklist (DBT-WCCL)
timeFrame: 21 months to 24 months
measure: Childhood Trust Events Survey (CTES)
timeFrame: Baseline
measure: Number, frequency, and type of therapy sessions
timeFrame: At the end of study completion (5 years)
Secondary outcomes:
measure: Adherence score for DBT booster sessions measured using a modified version of the Dialectical Behavior Therapy Adherence Checklist - Individual Therapy
timeFrame: At the end of study completion (five years)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Benjamin I Goldstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: