DBT-informed Care for Bipolar Disorder (DB3 Trial)
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Centre for Addiction and Mental Health
No Placebo Group
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.
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.
34589What 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.
24579How 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.
14569Do 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.
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.
I am between 13 and 23 years old.
Exclusion Criteria
I have a serious health issue that needs urgent treatment.
Participant Groups
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.
3Treatment groups
Experimental Treatment
Group I: Level 3Experimental Treatment1 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 2Experimental Treatment1 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 1Experimental Treatment1 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).
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Centre for Addiction and Mental HealthToronto, Canada
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Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
References
Cognitive-behavioral therapy: applications for the management of bipolar disorder. [2019]This paper reviews cognitive-behavioral therapy (CBT) for bipolar disorder (BD). Data on the poor outcome of about 50% of patients diagnosed with BD supports the addition of a psychosocial intervention for the treatment of this recurring disorder. The psychoeducational nature of CBT, the effectiveness of CBT in increasing compliance to pharmacological treatment, and the ability of CBT to prevent relapse in unipolar depression (UD) are well suited to the treatment of BD.
Care satisfaction, hope, and life functioning among adults with bipolar disorder: data from the first 1000 participants in the Systematic Treatment Enhancement Program. [2022]The Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) is designed to evaluate the longitudinal outcome of patients with bipolar disorder. The STEP-BD disease-management model is built on evidence-based practices and a collaborative care approach designed to maximize specific and nonspecific treatment mechanisms. This prospective study examined the longitudinal relationships between patients' satisfaction with care, levels of hope, and life functioning in the first 1000 patients to enter STEP-BD.
Suicide and suicide attempts in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). [2021]The current report describes individuals with bipolar disorder who attempted or completed suicide while participating in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) study.
A randomized, controlled, pilot study of dialectical behavior therapy skills in a psychoeducational group for individuals with bipolar disorder. [2018]Bipolar disorder (BD) is a chronic and disabling psychiatric disorder characterized by recurrent episodes of mania/hypomania and depression. Dialectical behavior therapy (DBT) techniques have been shown to effectively treat borderline personality disorder, a condition also marked by prominent affective disturbances. The utility of DBT techniques in treating BD has been largely unexplored. The purpose of this research was to conduct a pilot study of a DBT-based psychoeducational group (BDG) in treating euthymic, depressed, or hypomanic Bipolar I or II patients.
Dialectical behavior therapy for adolescents with bipolar disorder: results from a pilot randomized trial. [2022]The purpose of this study was to conduct a pilot randomized trial of dialectical behavior therapy (DBT) versus psychosocial treatment as usual (TAU) for adolescents diagnosed with bipolar disorder (BP).
Properties of the Dialectical Behavior Therapy Ways of Coping Checklist in a Diagnostically Diverse Partial Hospital Sample. [2019]Dialectical behavior therapy (DBT) was developed for treatment of borderline personality disorder (BPD), and adapted forms of DBT are currently used to treat bipolar disorder, eating disorders, anxiety, and depression. This study was designed to validate the Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) DBT Skills subscale (DSS) for use in a diagnostically heterogeneous sample.
A randomized trial of brief dialectical behaviour therapy skills training in suicidal patients suffering from borderline disorder. [2022]Evidence-based therapies for borderline personality disorder (BPD) are lengthy and scarce. Data on brief interventions are limited, and their role in the treatment of BPD is unclear. Our aim was therefore to evaluate the clinical effectiveness of brief dialectical behaviour therapy (DBT) skills training as an adjunctive intervention for high suicide risk in patients with BPD.
Description of a Dialectical Behavior Therapy program in a Veterans Affairs Health Care System. [2022]A comprehensive Dialectical Behavior Therapy (DBT) program was created within a VA Health Care System for patients with recent psychiatric hospitalization, suicidality and/or significant emotion dysregulation. The program was notable for being one of a relatively small number of comprehensive DBT programs in the VA system, and for including patients with psychosis and psychotic disorder, with a majority of patients (58%) having a documented history of psychosis or endorsing psychotic symptoms in assessments. We describe the process of creating this program at a VA medical center and present preliminary program evaluation data. All patients completed assessments of suicidality (C-SSRS), emotion dysregulation (DERS), skills use and dysfunctional coping (DBT-WCCL), borderline symptomatology (BSL-23), and depression (PHQ-9) at program entry and subsequently every 6-8 weeks through program completion. Suicide attempts and hospitalizations were also tracked. Twelve patients completed multiple (up to six) assessment timepoints, allowing for evaluation of change during treatment. Patients demonstrated improvements on most measures and no hospitalizations or suicide attempts during active treatment, and the subsample with psychosis showed average improvements on every outcome measure. Eleven of 12 patients completed a full six-month rotation.
A systematic review on the effectiveness of dialectical behavior therapy for improving mood symptoms in bipolar disorders. [2023]Evidence-based psychotherapies available to treat patients with bipolar disorders (BD) are limited. Dialectical behavior therapy (DBT) may target several common symptoms of BD. We conducted a systematic review on the efficacy of DBT for mood symptoms in patients with BD. The systematic search used key words related to DBT and BD in Medline, Embase, PsycInfo, CINAHL, and Cochrane Library databases from 1980 to April 1st, 2022. We included studies that enrolled patients with a BD I or II diagnosis (DSM or ICD), age 12 and older who received a DBT-based intervention. Studies reviewed were clinical trials including observational studies that reported at least one outcome related to BD mood symptoms or severity. We did not exclude based upon psychiatric or physical co-morbidity.