Dialectical Behavior Therapy (DBT) for Adolescents With Bipolar Disorder



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:12 - 18
Updated:7/8/2018
Start Date:February 2014
End Date:January 2020
Contact:Tina R Goldstein, PhD
Email:goldtr@upmc.edu
Phone:412-246-5604

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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.

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.

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.
We found this trial at
1
site
Pittsburgh, Pennsylvania 15213
Principal Investigator: Tina R Goldstein, Ph.D.
Phone: 412-246-5604
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Pittsburgh, PA
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