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

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ClinicalTrials.gov Identifier: NCT02003690
Recruitment Status : Recruiting
First Posted : December 6, 2013
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Tina R Goldstein, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Dialectical Behavior Therapy + Pharmacotherapy Standard of Care Psychotherapy + Pharmacotherapy Behavioral: Dialectical Behavior Therapy Behavioral: Standard of Care Psychotherapy Drug: Pharmacotherapy Phase 2

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. Furthermore, a supplement is enabling examination of neural mechanisms underlying DBT treatment response as assessed via fMRI at pre- and mid-treatment. These aims are in direct accord with the NIMH Strategic Plan to prioritize research on improved treatments for mental illness while also generating information regarding underlying mechanisms of disorder; 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dialectical Behavior Therapy (DBT) for Adolescents With Bipolar Disorder
Study Start Date : February 2014
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
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




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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003690


Contacts
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Contact: Tina R Goldstein, PhD 412-246-5604 goldtr@upmc.edu

Locations
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United States, Pennsylvania
Western Psychiatric Institute and Clinic / University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Tina R Goldstein, PhD    412-246-5604    goldtr@upmc.edu   
Principal Investigator: Tina R Goldstein, Ph.D.         
Sub-Investigator: Boris Birmaher, MD         
Sub-Investigator: Julie Donohue, Ph.D.         
Sub-Investigator: Melissa Saul, M.S.         
Sub-Investigator: Peter Franzen, Ph.D.         
Sub-Investigator: Mary Phillips, M.D.         
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Tina R Goldstein, PhD University of Pittsburgh

Publications of Results:
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Responsible Party: Tina R Goldstein, Associate Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02003690    
Other Study ID Numbers: MH100056
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Keywords provided by Tina R Goldstein, University of Pittsburgh:
Bipolar disorder
Adolescent suicidal behavior
Psychotherapy
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders