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Dialectical Behavior Therapy + PharmacotherapyDBTNCT02003690

Dialectical Behavior Therapy (DBT) for Adolescents With Bipolar Disorder

A study testing Dialectical Behavior Therapy and Pharmacotherapy in people with Dialectical Behavior Therapy + Pharmacotherapy and Standard of Care Psychotherapy + Pharmacotherapy, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 18 years
What is being tested?
Dialectical Behavior Therapy and Pharmacotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
18 Nov 2014to 31 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Western Psychiatric Institute and Clinic / University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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.

Read the 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.

Being tested
Dialectical Behavior Therapy, Standard of Care Psychotherapy, Pharmacotherapy
Keywords
Bipolar disorder, Adolescent suicidal behavior, Psychotherapy
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dialectical Behavior TherapyBehavioural

    Dialectical Behavior Therapy

  • Standard of Care PsychotherapyBehavioural

    Standard of Care Psychotherapy

  • PharmacotherapyOther

    Standard of Care Pharmacotherapy

Study groups in NCT02003690
Study groupRoleWhat they receive
Dialectical Behavior Therapy + PharmacotherapyExperimentalDialectical Behavior Therapy + Pharmacotherapy
Receives: Behavioral: Dialectical Behavior Therapy; Other: Pharmacotherapy
Standard of Care Psychotherapy + PharmacotherapyActive comparatorStandard of Care Psychotherapy + Pharmacotherapy
Receives: Behavioral: Standard of Care Psychotherapy; Other: Pharmacotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Suicidal events

    Suicidal events as assessed using the C-SSRS

    Measured: Over two year follow-up

  2. Mood symptoms

    As assessed using the KSADS-MRS and KSADS-DEP-P

    Measured: Over two year follow-up

Secondary outcomes (1)
  1. Cost effectiveness

    Cost effectiveness as assessed using utilization and costs from the healthcare payer and provider system perspectives

    Measured: Over two year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2013 (estimated)
  2. Study start18 Nov 2014
  3. Primary completion30 Sep 2021
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02003690
Sponsor's protocol ID
MH100056
Acronym
DBT
Status last verified
Aug 2022
First submitted
2 Dec 2013
Last updated
11 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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
  • Goldstein 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.

    PubMed 37703037

Questions about this trial

What is this clinical trial studying?

A study testing Dialectical Behavior Therapy and Pharmacotherapy in people with Dialectical Behavior Therapy + Pharmacotherapy and Standard of Care Psychotherapy + Pharmacotherapy, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Suicidal events (time frame: Over two year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02003690, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.

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