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Dialectical Behavior Therapy for Youth With and/or at Familial Risk for Bipolar Disorder

Study acronym: DB1
StatusRecruiting
PhaseNot applicable
Started2021-11-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 23 months later Nov 2026 → Nov 2028
See other at-risk trials from Centre for Addiction and Mental Health

Amendment history

2026-10-02
Primary completion pushed: 2026-11 → 2028-11
Completion pushed: 2026-11 → 2029-11
2025-11-17
Study Status, Contacts/Locations v7
Study sitescontacts updated at 1 of 1 site
2025-04-09
Study Identification, Study Status, Oversight, Contacts/Locations v6
Study sitescontacts updated at 1 of 1 site
Study titlerevised
Dialectical Behavior Therapy for Youth withWith Andand/or Atat Familial Risk for Bipolar Disorder
2025-03-21
Study Identification, Study Status, Oversight, Outcome Measures, Contacts/Locations v5
Primary endpoints41 entries, revised
Change in functioning using the Children's Global Assessment Scale (C-GAS) or Global Assessment of Functioning (GAF) Change in functioning using the Children's Global Assessment Scale (C-GAS) or Global Assessment of Functioning (GAF)
Study sitescontacts updated at 1 of 1 site
Study titlerevised
Dialectical Behavior Therapy for Youth Withwith andAnd/or atAt Familial Risk for Bipolar Disorder
2024-07-30
Study Status, Contacts/Locations v4
Study sitescontacts updated at 1 of 1 site
Show 3 earlier versions
2024-05-29
Study Status, Eligibility v3
Eligibility criteria+73 characters
[...] s, 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) [...] or organic central nervous system disorder by the K-SADS-PL (< 20 years of age), parent report, medical history, or school records that wou [...]
2024-04-17
Study Status, Eligibility, Contacts/Locations v2
Eligibility criteria-9 characters
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 OR have a biolog [...] g 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 CAMH psychiatrist who provides ongoing care; 6a) At least 1 lifetime suicide attempt in the past year (actual, interrupted, and/or aborted as measured by the C-SSRS) OR at least 1 preparatory act or behavior in the past year as measured by the C-SSRS O [...] [...]
2023-04-05
Study Identification, Study Status, Study Description, Arms and Interventions, Eligibility v1
Eligibility criteria+95 characters
[...] years, 11 months Meet diagnostic criteria for BD by KSADS-PL OR have a biological parent/sibling with BD (type I or II) confirmed via KSADS-PL or SCID-5-RV If BD-I, taking ≥1 mood stabilizing medication (i.e., antim [...]
Study description+110 characters
[...] with the unique needs of youth with bipolar disorder (BD). For the past two years, ourOur group has been conductingconducted a dissemination and implementation DBT study at Sunnybrook [...] eing delivered. The target sample size will be 60 youth with and/or at familial risk for BD ranging from 13 to 23 years of age. The current study en [...] he knowledge base in this area by offering DBT to youth with and/or at familial risk for BD at CAMH with an emphasis on predictors and mediators of [...] etween-person and within-person variability among youth with and/or at familial risk for BD in terms of risk indicators [...] [...]
Study title+28 characters
Dialectical Behavior Therapy for Youth With and/or at Familial Risk for Bipolar Disorder
2021-11-30
Original filing
Dialectical behavior therapy (DBT) will be conducted over 1 year in youth with and/or at familial risk for bipolar disorder (BD). DBT will be divided into two modalities: 1) DBT skills training; and 2) DBT individual therapy sessions. Skills training sessions will incorporate the 5 standard adolescent DBT modules: mindfulness skills, emotion regulation skills, distress tolerance skills, interpersonal skills, and walking the middle path skills and an additional module on psychoeducation about DBT and BD. This study seeks to build upon the knowledge base in this area by offering DBT to youth with and/or at familial risk for BD with an emphasis on predictors and mediators of treatment outcomes.
Trial Details
NCT Number NCT05153382
Lead Sponsor Centre for Addiction and Mental Health
Conditions Bipolar Disorder
Enrollment 60 participants
Start Date 2021-11-01
Primary Completion 2028-11 (estimated)
Study Completion 2029-11 (estimated)
Updated on ClinicalTrials.gov 2026-10-01