Dialectical Behavior Therapy for Bipolar Disorder

(DB2 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: Substance use disorder, Autism, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The study intervention is DBT adapted for youth with and/or at familial risk for bipolar disorder. Participants will have completed one full year of DBT in a previous study. This study is examining use of booster sessions. It is delivered in the form of individual sessions and skills sessions, based on the preference of the study participant. The study participant may also receive skills coaching via phone. There is no standard reference therapy/comparator against which the study intervention is being compared.

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 Bipolar Disorder?

Research suggests that Dialectical Behavior Therapy (DBT) can help improve mood symptoms and emotional control in people with bipolar disorder, similar to its success in treating borderline personality disorder, which also involves mood disturbances. ^{1 2 3 4 5}

Is Dialectical Behavior Therapy (DBT) safe for humans?

DBT has been used safely in various conditions, including borderline personality disorder and alcohol dependency, with studies showing it can reduce harmful behaviors and improve social adjustment without significant safety concerns. ^{1 4 6 7 8}

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

Dialectical Behavior Therapy (DBT) is unique because it was originally developed for borderline personality disorder and focuses on teaching skills to manage emotions and improve relationships, which may help address mood symptoms in bipolar disorder. Unlike standard treatments that primarily involve medication, DBT offers a structured psychoeducational approach that targets emotional regulation and coping strategies. ^{1 2 4 7 8}

Research Team

Benjamin I Goldstein, MD, PhD

Principal Investigator

Centre for Addiction and Mental Health

Eligibility Criteria

This trial is for young people aged 14 to nearly 26 who have bipolar disorder or are at risk due to family history. They must have finished a year of DBT in prior studies, be under care by a CAMH psychiatrist, and if they have BD-I, be on mood stabilizers. Participants need to speak English and consent to join.

Inclusion Criteria

Participant has completed participation in the DB1 study (049-2021) or the DB3 study (009-2021)

Participant is able and willing to give informed consent/assent to participate

I am between 14 and 26 years old.

Exclusion Criteria

Participant is a current victim of sexual or physical abuse

Participant has a current substance use disorder other than mild cannabis or alcohol use disorder

I have a serious health issue that needs urgent treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DBT booster sessions, including individual and skills sessions, with optional phone coaching

5 years

Follow-up

Participants are monitored for treatment satisfaction, symptom changes, and adherence to DBT booster sessions

33 to 36 months

Open-label extension (optional)

Participants may continue to receive DBT booster sessions based on their preference and consultation with their therapist

Long-term

Treatment Details

Interventions

• Dialectical Behavioral Therapy

Trial Overview The study tests 'booster' sessions of Dialectical Behavior Therapy (DBT) tailored for youth with/at risk for bipolar disorder. It includes individual therapy, skills training based on preference, and optional phone coaching. There's no comparison treatment; the focus is on these extra DBT sessions.

Participant Groups

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

120 youth aged 14 to 26 with bipolar disorder (type I, type II, not otherwise specified/NOS via KSADS-PL or SCID-5-RV) OR at high-risk for bipolar disorder (parent or sibling with bipolar disorder type I or II via KSADS-PL or SCID-5-RV) will be enrolled in the dialectical behavioral therapy booster session intervention.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Findings from Research

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]

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]

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 mania severity in patients with type 1 bipolar disorder, as evidenced by lower scores in the intervention group compared to the control group after 12 sessions of therapy.

While DBT improved executive functions and had a modest effect on depression, it did not significantly reduce emotional instability or impulsivity in these patients, indicating that it may be more effective for managing mania than for overall emotional regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Dialectical Behavioral Therapy on Executive Function, Emotional Control and Severity of Symptoms in Patients with Bipolar I Disorder. Zargar, F., Haghshenas, N., Rajabi, F., et al.[2022]

Dialectical behavior therapy (DBT) has been proven effective in reducing parasuicidal behaviors and improving social adjustment in patients with borderline personality disorder, as shown in two randomized trials.

The therapy's unique approach, which balances acceptance and change, was found to be more effective in reducing suicidal behavior compared to techniques focused solely on either acceptance or change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy for borderline personality disorder: theoretical and empirical foundations. Shearin, EN., Linehan, MM.[2022]

The Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) Skills subscale (DSS) has been validated for use in a diverse group of 228 patients, showing strong internal consistency and construct validity.

The psychometric properties of the DBT-WCCL DSS are comparable to those found in the original borderline personality disorder sample, confirming its effectiveness as an assessment tool for DBT skills across various psychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Properties of the Dialectical Behavior Therapy Ways of Coping Checklist in a Diagnostically Diverse Partial Hospital Sample. Stein, AT., Hearon, BA., Beard, C., et al.[2019]

Dialectical behavior therapy (DBT) was initially created for suicidal women with borderline personality disorder (BPD) but has been adapted successfully for other clinical groups, including those with substance use issues.

The authors propose a new DBT approach specifically for alcoholics with comorbid BPD, aiming to enhance treatment outcomes for this population, which typically faces more severe challenges and poorer responses to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of dialectical behavior therapy as in-patient treatment for alcohol dependency]. Mayer-Bruns, F., Lieb, K., Dannegger, E., et al.[2018]

References

1. 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]

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

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

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

Dialectical behavior therapy for adolescents with bipolar disorder: a 1-year open trial. [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. India pubmed.ncbi.nlm.nih.gov

Effectiveness of Dialectical Behavioral Therapy on Executive Function, Emotional Control and Severity of Symptoms in Patients with Bipolar I Disorder. [2022]

6. Denmark pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy for borderline personality disorder: theoretical and empirical foundations. [2022]

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

Properties of the Dialectical Behavior Therapy Ways of Coping Checklist in a Diagnostically Diverse Partial Hospital Sample. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

[Application of dialectical behavior therapy as in-patient treatment for alcohol dependency]. [2018]