Dialectical Behavior Therapy for Youth with Bipolar Disorder

(DB1 Trial)

Overseen By Amanda Moss, MSW

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Must be taking: Mood stabilizers

Disqualifiers: Mental retardation, Severe autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how dialectical behavior therapy (DBT) can assist young people with or at risk for bipolar disorder, a condition causing extreme mood swings. DBT teaches skills like mindfulness and emotion management through group skills training and individual sessions. The trial seeks to identify factors that might predict successful treatment outcomes. It suits English-speaking youth aged 13 to 23 with bipolar disorder or a family history of it, who have recently experienced self-harming behaviors or impulsivity. As an unphased trial, it provides a unique opportunity to contribute to groundbreaking research and potentially benefit from innovative therapy approaches.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have Bipolar Disorder type I, you must be taking at least one mood-stabilizing medication to participate.

What prior data suggests that dialectical behavior therapy is safe for youth with bipolar disorder?

Research has shown that Dialectical Behavior Therapy (DBT) is generally safe for teenagers with bipolar disorder. This therapy has undergone extensive testing and is well-received. For instance, one study found that DBT reduced the number of suicide attempts among high-risk teens, indicating its effectiveness and manageability. Other research supports its success compared to standard treatments, without major side effects. DBT involves learning skills like mindfulness and managing emotions, which do not cause harm, making it a safe choice for young people with bipolar disorder or those at risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Dialectical Behavior Therapy (DBT) is unique because it combines cognitive-behavioral techniques with mindfulness practices, offering a holistic approach to managing bipolar disorder in youth. Unlike standard medications like mood stabilizers or antipsychotics, which primarily target chemical imbalances, DBT focuses on helping individuals develop skills to manage intense emotions and reduce impulsive behaviors. Researchers are excited about DBT because it empowers young people to actively participate in their treatment and develop long-lasting coping strategies, potentially reducing the need for medication and minimizing side effects.

What evidence suggests that Dialectical Behavior Therapy might be an effective treatment for bipolar disorder?

Research has shown that dialectical behavior therapy (DBT) can help treat symptoms of bipolar disorder. Studies have found that DBT helps manage mood swings and reduces emotional highs and lows. One study found that DBT lowered the number of suicide attempts among teenagers with bipolar disorder. Participants in DBT often attended more therapy sessions, demonstrating high engagement and improvement in managing manic symptoms and controlling emotions. This trial will evaluate DBT as a treatment for young people with or at risk for bipolar disorder, building on these promising findings. ^{1 2 6 7 8}

Who Is on the Research Team?

Benjamin I Goldstein, MD, PhD

Principal Investigator

Centre for Addiction and Mental Health

Are You a Good Fit for This Trial?

This trial is for English-speaking youth aged 13 to nearly 24, who either have bipolar disorder and are on mood stabilizers or have a family history of it. They must be seeing a CAMH psychiatrist regularly and have a history of suicide attempts, self-harm, severe emotional distress, or impulsive behaviors.

Inclusion Criteria

I am taking medication to stabilize my mood for bipolar disorder.

Followed by a CAMH psychiatrist who provides ongoing care

Able and willing to give informed consent/assent to participate

Exclusion Criteria

Evidence of mental retardation, moderate to severe pervasive developmental disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records

I have a life-threatening condition that needs immediate treatment.

Current victim of sexual or physical abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Dialectical behavior therapy (DBT) conducted over 1 year, divided into DBT skills training and individual therapy sessions

52 weeks

Biweekly sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dialectical Behavioral Therapy

Trial Overview

The study tests Dialectical Behavior Therapy (DBT) over one year for young people with or at risk for bipolar disorder. It includes skills training in mindfulness, emotion regulation, distress tolerance, interpersonal effectiveness and psychoeducation about DBT and BD.

How Is the Trial Designed?

Group I: Youth with and/or at familial risk for bipolar disorder Experimental Treatment 1 Intervention

60 youth aged 13 to 23 with and/or at familial risk for bipolar disorder will be enrolled in the dialectical behavioral therapy intervention.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Published Research Related to This Trial

Dialectical behavior therapy (DBT) significantly reduced depressive symptoms in adolescents during inpatient treatment, as evidenced by lower scores on the Hamilton Depression Rating Scale compared to treatment as usual (TAU).

While DBT showed effectiveness in decreasing depressive symptoms, it did not demonstrate significant differences in manic symptoms or aggression compared to TAU, suggesting its primary benefit may be in managing depression in acute-care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical Behavior Therapy Decreases Depressive Symptoms Among Adolescents in an Acute-Care Inpatient Unit. Saito, E., Tebbett-Mock, AA., McGee, M.[2021]

In a pilot study involving 20 adolescents with bipolar disorder, those receiving dialectical behavior therapy (DBT) showed significantly less severe depressive symptoms and were nearly three times more likely to improve in suicidal ideation compared to those receiving standard psychosocial treatment.

DBT participants attended more therapy sessions, indicating higher engagement, and demonstrated improvements in manic symptoms and emotional dysregulation from pre- to post-treatment, suggesting that DBT may be a beneficial adjunct to medication for managing early-onset bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy for adolescents with bipolar disorder: results from a pilot randomized trial. Goldstein, TR., Fersch-Podrat, RK., Rivera, M., et al.[2022]

A pilot study involving 26 adults with bipolar I or II disorder showed that a 12-week dialectical behavior therapy (DBT)-based psychoeducational group led to reduced depressive symptoms and improved mindfulness and emotional control.

Participants in the DBT group also experienced fewer emergency room visits and mental health-related admissions in the six months following the intervention, suggesting potential benefits for overall mental health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled, pilot study of dialectical behavior therapy skills in a psychoeducational group for individuals with bipolar disorder. Van Dijk, S., Jeffrey, J., Katz, MR.[2018]

Dialectical behaviour therapy for adolescents (DBT-A) was effectively implemented in publicly funded mental health services in Ireland, involving 54 clinicians and 84 adolescents over a 16-week program.

Participants in the DBT-A program showed significant reductions in self-harm, suicidal thoughts, and depression, along with decreased hospital admissions and emergency visits, indicating its efficacy in treating emotional and behavioral dysregulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovations in Practice: Dialectical behaviour therapy for adolescents: multisite implementation and evaluation of a 16-week programme in a public community mental health setting. Flynn, D., Kells, M., Joyce, M., et al.[2020]

An adapted version of dialectical behavior therapy (DBT) for adolescents with bipolar disorder showed high feasibility and acceptability, with 90% of scheduled sessions attended and 9 out of 10 patients completing the treatment over one year.

Participants demonstrated significant improvements in key areas such as suicidality, self-injurious behavior, emotional dysregulation, and depressive symptoms, suggesting that DBT could be an effective psychosocial treatment for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy for adolescents with bipolar disorder: a 1-year open trial. Goldstein, TR., Axelson, DA., Birmaher, B., et al.[2018]

Dialectical behavior therapy (DBT) shows promise in improving mood symptoms in patients with bipolar disorder (BD), based on a systematic review of 11 studies involving various mood states, primarily excluding mania.

While DBT-based interventions were found to be feasible and acceptable for patients with BD, the overall confidence in these findings is limited due to small sample sizes and high risk of bias, indicating a need for larger, well-designed randomized controlled trials to confirm efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on the effectiveness of dialectical behavior therapy for improving mood symptoms in bipolar disorders. Jones, BDM., Umer, M., Kittur, ME., et al.[2023]

Citations

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Dialectical behavior therapy (DBT) may target several common symptoms of BD. We conducted a systematic review on the efficacy of DBT for mood ...

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Dialectical behavior therapy (DBT) will be conducted over 1 year in youth with and/or at familial risk for bipolar disorder (BD). DBT will be divided into ...

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jamanetwork.com/journals/jamapsychiatry/fullarticle/2809647

Dialectical Behavior Therapy for Adolescents With Bipolar ...

In this randomized clinical trial, DBT demonstrated efficacy in decreasing suicide attempts among the high-risk population of adolescents with bipolar spectrum ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37703037/

Dialectical Behavior Therapy for Adolescents With Bipolar ...

In this randomized clinical trial, DBT demonstrated efficacy in decreasing suicide attempts among the high-risk population of adolescents with bipolar spectrum ...

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withpower.com

withpower.com/trial/phase-bipolar-disorder-10-2022-089a8

Dialectical Behavior Therapy for Bipolar Disorder (DB2 Trial)

DBT participants attended more therapy sessions, indicating higher engagement, and demonstrated improvements in manic symptoms and emotional dysregulation from ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10500432/

Dialectical Behavior Therapy for Adolescents With Bipolar ...

This randomized clinical trial evaluates whether dialectical behavior therapy for adolescents with bipolar spectrum disorder is more effective than standard of ...

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Dialectical Behavior Therapy for Youth With and/or at ...

Overview. Dialectical behavior therapy (DBT) will be conducted over 1 year in youth with and/or at familial risk for bipolar disorder (BD).

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withpower.com/trial/phase-bipolar-disorder-10-2021-fdd6b

Dialectical Behavior Therapy for Youth with Bipolar Disorder

Research on Dialectical Behavior Therapy (DBT) for adolescents with bipolar disorder suggests it is generally safe, as it has been used in various studies ...