NCT02003690: DBT

Dialectical Behavior Therapy (DBT) for Adolescents With Bipolar Disorder

Completed NA Last updated 11 August 2022

What this trial tests

NA trial testing Dialectical Behavior Therapy in Dialectical Behavior Therapy + Pharmacotherapy in 100 participants. Completed in 31 March 2022.

Timeline

18 November 2014

Primary endpoint
30 September 2021

31 March 2022

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	18 November 2014
Primary completion	30 September 2021
Estimated completion	31 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Dialectical Behavior Therapy
• Standard of Care Psychotherapy
• Pharmacotherapy — full drug profile →

Conditions studied

• Dialectical Behavior Therapy + Pharmacotherapy — all drugs for Dialectical Behavior Therapy + Pharmacotherapy →
• Standard of Care Psychotherapy + Pharmacotherapy — all drugs for Standard of Care Psychotherapy + Pharmacotherapy →

Sponsor

University of Pittsburgh

Who can join

Adults 12 to 18, any sex, with Dialectical Behavior Therapy + Pharmacotherapy or Standard of Care Psychotherapy + Pharmacotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Dialectical Behavior Therapy for Adolescents With Bipolar Disorder: A Randomized Clinical Trial.
   Goldstein TR, Merranko J, Rode N, Sylvester R, et al · · 2024 · cited 25× · PMID 37703037 · DOI 10.1001/jamapsychiatry.2023.3399