DBT-informed Care for Bipolar Disorder

(DB3 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: 21 to 24 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This study seeks to bridge the knowledge-to-action gap regarding psychosocial treatment "dosing" for youth with and/or at familial risk for bipolar disorder (BD). In psychiatry, pragmatic collaborative decisions between patient and care provider about pharmacological titrations and tapers are common. Less frequently are there considerations made regarding the pragmatic dosing of psychosocial interventions. Whereas some youth clearly require full/"high-dose" treatment, others may benefit from "lower-dose" interventions, alongside re-evaluation of dosing needs over time. Furthermore, there is a subset of youth who do not require or do not want the intensity and frequency of treatment that current interventions provide. This research presents a unique opportunity to better understand different levels of care within a subspecialized outpatient mental health clinic serving youth with and/or at familial risk for BD who vary greatly in terms of risk indicators, type and severity of symptoms, associated distress, and compounding functional impairment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop 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 DBT-informed Care for Bipolar Disorder?

Research suggests that Dialectical Behavior Therapy (DBT) can help improve mood symptoms in people with bipolar disorder, as it has been effective in treating similar emotional disturbances in borderline personality disorder. A systematic review and pilot studies indicate that DBT techniques may be beneficial for managing mood symptoms in bipolar disorder. ^{1 2 3 4 5}

Is DBT-informed care safe for humans?

Research on Dialectical Behavior Therapy (DBT) shows it is generally safe for humans, with studies reporting no hospitalizations or suicide attempts during active treatment in a Veterans Affairs program, even among patients with severe conditions like psychosis. ^{2 3 4 6 7}

How is the DBT-informed Care treatment for bipolar disorder different from other treatments?

DBT-informed Care for bipolar disorder is unique because it adapts Dialectical Behavior Therapy (DBT), originally developed for borderline personality disorder, to help manage mood symptoms in bipolar disorder. This treatment focuses on teaching coping skills and emotional regulation, which are not typically emphasized in standard bipolar disorder treatments. ^{2 3 4 8 9}

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 almost 24 with bipolar disorder. Participants must be diagnosed by KSADS-PL, and if they have Bipolar I, they should be on mood stabilizing medication. They need ongoing care from a CAMH psychiatrist and must consent to join the study. It's not for those with certain developmental disorders, current abuse victims, life-threatening conditions, or severe substance use issues.

Inclusion Criteria

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

I have been diagnosed with bipolar disorder or have a close relative with it.

Able and willing to give informed consent/assent to participate

Exclusion Criteria

Meets assessment criteria for Level 3 at enrollment

Current victim of sexual or physical abuse

Current substance use disorder other than mild cannabis or alcohol use disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a multi-level DBT-informed intervention tailored to their risk indicators and symptom severity, with varying session frequency and parental involvement

21 to 24 months

Follow-up

Participants are monitored for changes in symptoms, suicidality, and emotion regulation using various questionnaires and scales

6 months

Open-label extension (optional)

Participants may continue to receive DBT-informed care based on their ongoing needs and preferences

Long-term

Treatment Details

Interventions

• DBT Skills Training
• Dialectical Behavior Therapy Full Intervention
• Enhanced Care

Trial Overview The study tests different 'doses' of psychosocial treatments in youths at risk for or with bipolar disorder: Enhanced Care (low dose), Full Dialectical Behavior Therapy (high dose), and DBT Skills Training (medium dose). The goal is to find out which level of intervention works best depending on individual needs.

Participant Groups

Group I: Level 3 Experimental Treatment 1 Intervention

At enrollment, participants will be categorized according to the following criteria related to suicidality, emotion dysregulation, risk behaviors, and participant preference: NSSI behaviors in the past 3 months on the C-SSRS OR at least 1 suicide attempt in the past year (actual, interrupted, and/or aborted) on the C-SSRS OR at least 1 preparatory act or behavior in the past year as measured by the C-SSRS OR Meets youth threshold for at least 2 impulsive behavior categories on question #4 from the Structured Interview for DSM-IV Personality Disorders Borderline Personality Disorder (SIDP-IV) or 1 category is identified as severe OR participant preference during the course of treatment.

Group II: Level 2 Experimental Treatment 1 Intervention

At enrollment, participants will be categorized according to the following criteria related to suicidality, emotion dysregulation, risk behaviors, and participant preference: No non-suicidal self-injurious (NSSI) behaviors in the past 3 months on the C-SSRS AND no suicide attempts (actual, interrupted and/or aborted) in the past year on the C-SSRS AND no preparatory act or behavior in the past year as measured by the C-SSRS OR participant preference.

Group III: Level 1 Experimental Treatment 1 Intervention

At enrollment, participants will be categorized according to the following criteria related to suicidality, emotion dysregulation, risk behaviors, and participant preference: No lifetime suicidal behaviors on the Columbia-Suicide Severity Rating Scale (C-SSRS) AND no active suicidal ideations with method/plan/intent in the past month on the C-SSRS (cannot score 'yes' on items \> 3).

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Findings from Research

In a study of 1000 patients with bipolar disorder, higher satisfaction with care was linked to lower levels of hopelessness, indicating that improving patient care can enhance their outlook on life.

Decreased hopelessness was associated with better life functioning, suggesting that fostering hope in patients may help them manage their illness more effectively, even though it did not directly affect symptoms of depression or mania.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care satisfaction, hope, and life functioning among adults with bipolar disorder: data from the first 1000 participants in the Systematic Treatment Enhancement Program. Morris, CD., Miklowitz, DJ., Wisniewski, SR., et al.[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]

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]

A study involving 84 out-patients with borderline personality disorder (BPD) found that 20 weeks of brief dialectical behavior therapy (DBT) skills training significantly reduced suicidal and self-injurious behaviors compared to a waitlist group.

Participants receiving DBT also showed notable improvements in anger management, distress tolerance, and emotion regulation, suggesting that this brief intervention can effectively support high-risk behaviors in BPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of brief dialectical behaviour therapy skills training in suicidal patients suffering from borderline disorder. McMain, SF., Guimond, T., Barnhart, R., et al.[2022]

In a study of 4360 individuals with bipolar disorder, 182 experienced suicidal acts, resulting in a suicide rate of 0.014 per 100 person years, indicating that structured care may reduce suicide risk.

The study found that those who completed suicide often did so early in their participation, with half of the completed suicides occurring on the first attempt, highlighting the critical need for early intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide and suicide attempts in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). Dennehy, EB., Marangell, LB., Allen, MH., et al.[2021]

A comprehensive Dialectical Behavior Therapy (DBT) program was developed for patients with recent psychiatric hospitalization and significant emotion dysregulation, including a notable 58% of participants having a history of psychosis.

Preliminary evaluation showed that patients improved on most measures of suicidality, emotion regulation, and depression, with no hospitalizations or suicide attempts during treatment, indicating the program's potential efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description of a Dialectical Behavior Therapy program in a Veterans Affairs Health Care System. Phalen, P., Grossmann, J., Bruder, T., et al.[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]

Cognitive-behavioral therapy (CBT) shows promise as an effective adjunctive treatment for bipolar disorder (BD), potentially improving patient compliance with medication, quality of life, and early symptom recognition.

Preliminary results suggest that CBT may help reduce relapse rates and depressive symptoms in BD, but more rigorous randomized clinical trials are necessary to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy: applications for the management of bipolar disorder. Patelis-Siotis, I.[2019]

References

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

Care satisfaction, hope, and life functioning among adults with bipolar disorder: data from the first 1000 participants in the Systematic Treatment Enhancement Program. [2022]

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

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

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

A randomized trial of brief dialectical behaviour therapy skills training in suicidal patients suffering from borderline disorder. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Suicide and suicide attempts in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). [2021]

7. England pubmed.ncbi.nlm.nih.gov

Description of a Dialectical Behavior Therapy program in a Veterans Affairs Health Care System. [2022]

8. 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]

9. Denmark pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy: applications for the management of bipolar disorder. [2019]