Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT05153369
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2021-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Three-level Model of DBT-informed Care for Youth With and/or at Familial Risk for Bipolar Disorder (DB3)
Sponsor:
Centre for Addiction and Mental Health
Organization:
Study Overview
Official Title:
Personalized and Pragmatic Three-level Model of DBT-informed Care for Youth With and/or at Familial Risk for Bipolar Disorder
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DB3
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: