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

Официальное название

Personalized and Pragmatic Three-level Model of DBT-informed Care for Youth With and/or at Familial Risk for Bipolar Disorder

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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, coveri
• Поведенческое 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, an
• Поведенческое 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

Первичные конечные точки

• Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder [Срок оценки: Baseline to 6 months]
• Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder [Срок оценки: 6 months to 12 months]
• Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder [Срок оценки: 12 months to 18 months]
• Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder [Срок оценки: 18 months to 24 months]
• Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [Срок оценки: Baseline to 3 months]
• Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [Срок оценки: 3 months to 6 months]
• Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [Срок оценки: 6 months to 9 months]
• Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [Срок оценки: 9 months to 12 months]
• Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [Срок оценки: 12 months to 15 months]
• Change in symptoms using the Mood and Feelings Questionnaire (MFQ) [Срок оценки: 15 months to 18 months]

Вторичные конечные точки (1)

• Adherence score for DBT booster sessions measured using a modified version of the Dialectical Behavior Therapy Adherence Checklist - Individual Therapy [Срок оценки: At the end of study completion (five years)]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Centre for Addiction and Mental Health — Toronto

Идентификаторы

NCT: NCT05153369 · 009/2021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗