Dialectical Behavior Therapy for Youth with Bipolar Disorder

(DB1 Trial)

Overseen By Diana Khoubaeva, 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

Trial Summary

What is the purpose of this trial?

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 two modalities: 1) DBT skills training; and 2) DBT individual therapy sessions. Skills training sessions will incorporate the 5 standard adolescent DBT modules: mindfulness skills, emotion regulation skills, distress tolerance skills, interpersonal skills, and walking the middle path skills and an additional module on psychoeducation about DBT and BD. This study seeks to build upon the knowledge base in this area by offering DBT to youth with and/or at familial risk for BD with an emphasis on predictors and mediators of treatment outcomes.

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 data supports the effectiveness of the treatment Dialectical Behavior Therapy for youth with bipolar disorder?

Research suggests that Dialectical Behavior Therapy (DBT) can help reduce depressive symptoms in adolescents, and it has been effective in treating mood-related issues in other conditions like borderline personality disorder. While specific data on DBT for bipolar disorder is limited, these findings indicate potential benefits for mood stabilization in youth with bipolar disorder. ^{1 2 3 4 5}

Is Dialectical Behavior Therapy (DBT) safe for adolescents 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 without significant safety concerns. DBT is a well-established therapy for emotional and behavioral issues, and while its effectiveness for bipolar disorder is still being studied, safety data from these trials indicate it is safe for use in humans. ^{1 2 3 4 6}

How is Dialectical Behavior Therapy (DBT) different from other treatments for bipolar disorder in youth?

Dialectical Behavior Therapy (DBT) is unique because it combines cognitive-behavioral techniques with mindfulness practices to help manage emotions and behaviors, which is particularly beneficial for adolescents with bipolar disorder who experience intense mood swings. Unlike standard treatments, DBT focuses on teaching skills to improve emotional regulation and interpersonal effectiveness, which can be especially helpful for managing the mood symptoms associated with bipolar disorder. ^{1 2 3 4 5}

Research Team

Benjamin I Goldstein, MD, PhD

Principal Investigator

Centre for Addiction and Mental Health

Eligibility Criteria

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

Current victim of sexual or physical abuse

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy for adolescents with bipolar disorder: results from a pilot randomized trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy for adolescents with bipolar disorder: a 1-year open trial. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized, controlled, pilot study of dialectical behavior therapy skills in a psychoeducational group for individuals with bipolar disorder. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

A systematic review on the effectiveness of dialectical behavior therapy for improving mood symptoms in bipolar disorders. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Dialectical Behavior Therapy Decreases Depressive Symptoms Among Adolescents in an Acute-Care Inpatient Unit. [2021]

6. England 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. [2020]