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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how booster sessions of Dialectical Behavioral Therapy (DBT) can assist young people with or at risk for bipolar disorder. DBT is a therapy that helps individuals manage emotions and behaviors. The trial targets those who have completed a year of DBT and seek to continue their progress with extra support through individual or skills sessions and phone coaching. Participants should have a diagnosis of bipolar disorder or a close family member with the condition and must already be under a psychiatrist’s care. As an unphased trial, this study offers a unique opportunity for participants to receive additional support and potentially enhance their mental health management.

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 this protocol is safe for youth with and/or at familial risk for bipolar disorder?

Research has shown that Dialectical Behavior Therapy (DBT) is generally safe for people with bipolar disorder. One study found that DBT reduced suicide attempts in teenagers with bipolar disorder, indicating it is well-tolerated by them. Another study examined the long-term effects of DBT for teenagers with bipolar disorder to assess its effectiveness and acceptability over time.

These findings suggest that DBT can be a safe and manageable option for those at risk of or living with bipolar disorder. While further research could provide additional insights, current evidence supports DBT as a safe choice for those considering it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Dialectical Behavior Therapy (DBT) is unique for bipolar disorder because it combines cognitive-behavioral techniques with mindfulness strategies, which can help manage intense emotions and improve interpersonal relationships. Unlike standard treatments, such as mood stabilizers and antipsychotic medications, DBT provides practical skills for emotion regulation and distress tolerance, potentially reducing the need for medication adjustments. Researchers are excited about DBT because it specifically targets emotional dysregulation, a core challenge in bipolar disorder, offering a holistic approach that empowers individuals with tools to navigate their mood swings more effectively.

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

Research has shown that Dialectical Behavior Therapy (DBT), which participants in this trial will receive, can help people with bipolar disorder. Studies have found that DBT lessens the severity of manic episodes and reduces suicide attempts in teenagers with bipolar disorders. Additionally, evidence indicates that DBT helps people manage their emotions better and be more mindful, meaning they become more aware and present in the moment. These benefits suggest that DBT could be a good option for managing symptoms of bipolar disorder. ^{1 3 5 6 7}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6796294/

Effectiveness of Dialectical Behavioral Therapy on ... DBT has been effective in decreasing the intensity of mania, but, it cannot be used to reduce the emotional instability and impulsivity of these ...

2. jamanetwork.com 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9899872/

A systematic review on the effectiveness of dialectical ... Dialectical behavior therapy for adolescents with bipolar disorder: results from a pilot randomized trial. J Child Adolesc Psychopharmacol ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032712004375

A randomized, controlled, pilot study of dialectical behavior ... There is preliminary evidence that DBT skills reduce depressive symptoms, improve affective control, and improve mindfulness self-efficacy in BD ...

5. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.psychotherapy.20230006

Dialectical Behavior and Social Rhythm Therapy for ... Taken together, DBT has shown promise in treating bipolar disorder among adolescents and adults. However, we argue that DBT alone may not ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04283188

12-Month Extension Study of Dialectical Behavior Therapy ... The overarching goal of this project is to evaluate the longer-term effects of implementing DBT for adolescents with BD in a subspecialty clinic.

7. sciencedirect.com sciencedirect.com/science/article/pii/S016503272400630X

BI-REAL: A 12-session DBT skills group intervention ... The principal aim of this study was to evaluate the feasibility and acceptability of the Bi-REAL programme, a Dialectical Behaviour Therapy ...