History of Changes for Study: NCT02003690

Dialectical Behavior Therapy (DBT) for Adolescents With Bipolar Disorder (DBT)

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Study Record Versions

Version	Submitted Date	Changes
1	December 2, 2013	None (earliest Version on record)
2	December 18, 2014	Recruitment Status, Study Status, Contacts/Locations and Oversight
3	January 5, 2016	Study Status
4	January 6, 2016	Study Status
5	August 4, 2016	Study Status, Contacts/Locations and Study Description
6	August 10, 2017	Study Status
7	July 5, 2018	Study Status
8	June 7, 2019	Study Status
9	March 20, 2020	Recruitment Status, Study Status and Contacts/Locations
10	February 2, 2021	Study Status
11	August 2, 2021	Study Status
12	September 2, 2021	Study Status
13	January 5, 2022	Study Status
14	May 16, 2022	Recruitment Status, Study Status and Study Design
15	July 25, 2022	Study Status
16	August 9, 2022	Arms and Interventions, Oversight, Study Status and Study Design

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	MH100056
Brief Title:	Dialectical Behavior Therapy (DBT) for Adolescents With Bipolar Disorder (DBT)
Official Title:	Dialectical Behavior Therapy (DBT) for Adolescents With Bipolar Disorder
Secondary IDs:

Study Status


Record Verification:	December 2013
Overall Status:	Not yet recruiting
Study Start:	February 2014
Primary Completion:	January 2019 [Anticipated]
Study Completion:	January 2019 [Anticipated]

First Submitted:	December 2, 2013
First Submitted that Met QC Criteria:	December 2, 2013
First Posted:	December 6, 2013 [Estimate]

Last Update Submitted that Met QC Criteria:	December 2, 2013
Last Update Posted:	December 6, 2013 [Estimate]

Sponsor/Collaborators


Sponsor:	University of Pittsburgh
Responsible Party:	Principal Investigator Investigator: Tina R Goldstein Official Title: Associate Professor of Psychiatry Affiliation: University of Pittsburgh
Collaborators:	National Institute of Mental Health (NIMH)

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

Study Description

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.

Detailed Description:

Of all psychiatric diagnoses, bipolar disorder (BP) imparts the greatest risk for completed suicide in adolescence, and is associated with other negative outcomes including poor psychosocial functioning and substance abuse. Furthermore, healthcare costs for adolescents with BP exceed those for other adolescent psychiatric conditions. Treatment guidelines indicate optimal management of pediatric BP includes a combination of pharmacotherapy and psychotherapy. Yet, little is known about effective psychotherapy approaches for this population, and none expressly target suicidality. An efficacious, cost-effective psychotherapy for adolescents with BP has great potential to decrease the substantial morbidity, mortality and costs associated with this illness. Dialectical Behavior Therapy (DBT) is a skills-based psychotherapy originally developed for adults with borderline personality disorder. DBT holds promise for adolescents with BP given shared treatment targets including suicidality and psychosocial functioning. Our group's preliminary data on DBT for adolescents with BP provide strong support for the feasibility and acceptability of the treatment model, and indicate DBT is associated with improvement in targeted treatment domains including suicidality, emotional dysregulation, and depression, and these improvements are greater among adolescents receiving DBT as compared with standard of care (SOC) psychotherapy delivered at our Child and Adolescent Bipolar Services (CABS) specialty clinic. The proposed study aims to evaluate in a randomized controlled trial the efficacy of DBT + pharmacotherapy as compared with CABS SOC psychotherapy + pharmacotherapy over 2 year followup among adolescents (age 12-18) with BP (n=100). Primary outcome domains include suicidal events and mood symptoms. Our team includes an expert in health services cost effectiveness, enabling us to examine the cost effectiveness of DBT. Our exploratory aim is to elucidate moderators and mediators of DBT treatment response in this population. Identification of patient factors that predict response to DBT, as well as mechanisms by which DBT benefits patients, will directly inform the planful dissemination of the treatment (if shown to be effective) for those most likely to benefit. These aims are in direct accord with the NIMH Strategic Plan to prioritize research on improved treatments for mental illness; facilitate widespread use of evidencebased interventions by demonstrating cost effectiveness; and systematically study elements of personalized intervention. Furthermore, this project aligns with the mission of the National Action Alliance for Suicide Prevention Research Prioritization Task Force: to prioritize gaps in the research that will reduce the rate of suicide and suicide attempts, to target particularly high-risk groups, and to move toward uptake of evidence-based interventions for suicidality.

Conditions


Conditions:	Dialectical Behavior Therapy + Pharmacotherapy Standard of Care Psychotherapy + Pharmacotherapy
Keywords:	Bipolar disorder Adolescent suicidal behavior Psychotherapy

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Single (Outcomes Assessor)
Allocation:	Randomized
Enrollment:	100 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Dialectical Behavior Therapy + Pharmacotherapy Dialectical Behavior Therapy + Pharmacotherapy	Behavioral: Dialectical Behavior Therapy Dialectical Behavior Therapy Drug: Pharmacotherapy Standard of Care Pharmacotherapy
Active Comparator: Standard of Care Psychotherapy + Pharmacotherapy Standard of Care Psychotherapy + Pharmacotherapy	Behavioral: Standard of Care Psychotherapy Standard of Care Psychotherapy Drug: Pharmacotherapy Standard of Care Pharmacotherapy

Outcome Measures


Primary Outcome Measures:
1.	Suicidal events [ Time Frame: Over two year follow-up ] Suicidal events as assessed using the C-SSRS
2.	Mood symptoms [ Time Frame: Over two year follow-up ] As assessed using the KSADS-MRS and KSADS-DEP-P
Secondary Outcome Measures:
1.	Cost effectiveness [ Time Frame: Over two year follow-up ] Cost effectiveness as assessed using utilization and costs from the healthcare payer and provider system perspectives

Eligibility


Minimum Age:	12 Years
Maximum Age:	18 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: For the proposed study, inclusion criteria are as follows: 1) age 12 years, 0 months to 18 years, 11 months; 2) a diagnosis of Bipolar Disorder (BP) I, II or NOS by the K-SADS-PL with an acute manic, mixed or depressive episode in the 3 months preceding study entry; 3) willing to engage in pharmacotherapy treatment at the CABS specialty clinic; 4) at least one parent or guardian with whom the patient lives or interacts on a significant basis (5 hours per week or more) who is willing to participate in DBT skills training; 5) English language fluency and at minimum a 3rd grade literacy level; 6) able and willing to give informed consent/assent to participate. Exclusion Criteria: For the proposed study, exclusion criteria are as follows: 1) evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records; 2) a life-threatening medical condition requiring immediate treatment; 3) current victim of sexual or physical abuse.

Contacts/Locations


Central Contact Person:	Tina R Goldstein, PhD Telephone: 412-246-5604 Email: goldtr@upmc.edu
Study Officials:	Tina R Goldstein, PhD Principal Investigator University of Pittsburgh
Locations:	United States, Pennsylvania
	Western Psychiatric Institute and Clinic / University of Pittsburgh Pittsburgh, Pennsylvania, United States, 15213 Contact:Contact: Tina R Goldstein, PhD 412-246-5604 goldtr@upmc.edu Contact:Principal Investigator: Tina R Goldstein, Ph.D. Contact:Sub-Investigator: Boris Birmaher, MD Contact:Sub-Investigator: Julie Donohue, Ph.D. Contact:Sub-Investigator: Melissa Saul, M.S.

IPDSharing


Plan to Share IPD:

References


Citations:	[Study Results] 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. PubMed 17581446
Links:
Available IPD/Information: