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Pragmatic Patient-oriented Extension Study of Dialectical Behavior Therapy Booster Sessions for Youth With and/or at Familial Risk for Bipolar Disorder

Study acronym: DB2
StatusRecruiting
PhaseNot applicable
Started2022-11-09
View on ClinicalTrials.gov ↗

Amendment history

2025-11-17
Study Status v8
Re-verified, no change to tracked fields
2025-04-09
Study Status, Contacts/Locations v7
Study sitescontacts updated at 1 of 1 site
2024-08-23
Study Status, Eligibility v6
Eligibility criteria-5 characters
[...] I or II) confirmed via KSADS-PL or SCID-5-RV; Followed by a CAMH psychiatrist who provides ongoing care; If BD-I, taking ≥1 [...]
2024-07-30
Study Status, Contacts/Locations v5
Study sitescontacts updated at 1 of 1 site
2024-06-14
Study Status, Arms and Interventions, Eligibility v4
Eligibility criteria+66 characters
[...] onths to 26 years, 11 months; Meets diagnostic criteria for BDbipolar disorder 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) [...]
Show 3 earlier versions
2023-10-20
Study Identification, Study Status, Arms and Interventions, Outcome Measures, Eligibility v3
Primary completion date2027-11-30→2028-11-30
Completion date2027-11-30→2028-11-30
Eligibility criteriarevised
[...] udy (009-2021); English speaking; Age 14 years, 0 months to 2526 years, 11 months; Meets diagnostic criteria for BD by KSADS [...]
Secondary endpoints28 to 54 entries
Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder Change in symptoms using the Structured Interview for DSM-IV Personality Disorders (SIDP-IV): Borderline Personality Disorder Change in suicidality using the Suicidal Ideatio [...]
Study title-9 characters
Pragmatic Patient-oriented 12-Month Extension Study of Dialectical Behavior Therapy Booster Ses [...]
2023-04-26
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v2
Eligibility criteria+338 characters
[...] ars, 11 months; Meets 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; Followed by a CAMH psychiatrist who provides ongoing care; [...] se disorder other than mild cannabis or alcohol use disorder; Evidence of mental retardation, moderate to severe autism spectrum disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records that would interfere with active participation in DBT.
Secondary endpoints28 entries, revised
Adherence score for DBT booster sessions measured using a modified version of the Dialectical Behavior Therapy Adherence Checklist - Individual Therapy
Study description+28 characters
The study intervention is DBT adapted for youth with and/or at familial risk for bipolar disorder. Participants will have completed one full [...]
Study title+28 characters
Pragmatic Patient-oriented 12-Month Extension Study of Dialectical Behavior Therapy Booster Sessions for Youth With and/or at Familial Risk for Bipolar Disorder
2023-02-06
Study Status v1
Primary completion date2027-11-18→2027-11-30
Completion date2027-11-18→2027-11-30
Start dateestimated 2022-11-18→confirmed 2022-11-09
2022-11-17
Original filing
The study intervention is DBT adapted for youth with and/or at familial risk for bipolar disorder. Participants will have completed one full year of DBT in a previous study. This study is examining use of booster sessions. It is delivered in the form of individual sessions and skills sessions, based on the preference of the study participant. The study participant may also receive skills coaching via phone. There is no standard reference therapy/comparator against which the study intervention is being compared.
Trial Details
NCT Number NCT05627492
Lead Sponsor Centre for Addiction and Mental Health
Conditions Bipolar Disorder
Enrollment 120 participants
Start Date 2022-11-09
Primary Completion 2028-11-30 (estimated)
Study Completion 2028-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-10-01