Dialectical Behavior Therapy (DBT) for Adolescents With Bipolar Disorder
DBT
1 other identifier
interventional
100
1 country
1
Brief Summary
Of all psychiatric diagnoses, bipolar disorder imparts the greatest risk for completed suicide in adolescence, and is further associated with poor psychosocial functioning, substance abuse and legal difficulties, and exorbitant healthcare costs exceeding those for other adolescent psychiatric conditions. Treatment guidelines indicate optimal management of pediatric bipolar disorder includes a combination of medication and psychotherapy. Yet, little is known about effective psychotherapy approaches for this population, and none expressly target suicidality. An efficacious, cost-effective psychosocial intervention for adolescents with bipolar disorder has great potential to decrease the substantial morbidity, mortality and costs associated with adolescent bipolar disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2013
CompletedFirst Posted
Study publicly available on registry
December 6, 2013
CompletedStudy Start
First participant enrolled
November 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedAugust 11, 2022
August 1, 2022
6.9 years
December 2, 2013
August 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Suicidal events
Suicidal events as assessed using the C-SSRS
Over two year follow-up
Mood symptoms
As assessed using the KSADS-MRS and KSADS-DEP-P
Over two year follow-up
Secondary Outcomes (1)
Cost effectiveness
Over two year follow-up
Study Arms (2)
Dialectical Behavior Therapy + Pharmacotherapy
EXPERIMENTALDialectical Behavior Therapy + Pharmacotherapy
Standard of Care Psychotherapy + Pharmacotherapy
ACTIVE COMPARATORStandard of Care Psychotherapy + Pharmacotherapy
Interventions
Dialectical Behavior Therapy
Standard of Care Psychotherapy
Standard of Care Pharmacotherapy
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Western Psychiatric Institute and Clinic / University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (2)
Goldstein TR, Axelson DA, Birmaher B, Brent DA. Dialectical behavior therapy for adolescents with bipolar disorder: a 1-year open trial. J Am Acad Child Adolesc Psychiatry. 2007 Jul;46(7):820-30. doi: 10.1097/chi.0b013e31805c1613.
PMID: 17581446RESULTGoldstein TR, Merranko J, Rode N, Sylvester R, Hotkowski N, Fersch-Podrat R, Hafeman DM, Diler R, Sakolsky D, Franzen P, Birmaher B. Dialectical Behavior Therapy for Adolescents With Bipolar Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Jan 1;81(1):15-24. doi: 10.1001/jamapsychiatry.2023.3399.
PMID: 37703037DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tina R Goldstein, PhD
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry
Study Record Dates
First Submitted
December 2, 2013
First Posted
December 6, 2013
Study Start
November 18, 2014
Primary Completion
September 30, 2021
Study Completion
March 31, 2022
Last Updated
August 11, 2022
Record last verified: 2022-08