Behavioral Intervention

Youth with and/or at familial risk for bipolar disorder for Bipolar Disorder

Centre for Addiction and Mental Health, Toronto, Canada
Targeting 2 different conditionsDialectical behavioral therapyN/ARecruitingLed by Benjamin I Goldstein, MD, PhDResearch Sponsored by Centre for Addiction and Mental Health

Study Summary

This trial is studying the use of additional help (booster sessions) for youth with bipolar disorder who have already completed 1 year of Dialectical Behavioral Therapy. Sessions and skills coaching are offered depending on the participant's preference.

Eligible Conditions
  • Bipolar Disorder


Screening ~ 3 weeks
Treatment ~ Varies
Follow ups ~ at the end of study completion (five years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of study completion (five years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequencies of different factors/circumstances leading to the need for unscheduled/expedited DBT sessions measured using the Therapy
Number of unscheduled/expedited DBT sessions that are required measured using the Therapy
Total number of DBT sessions used during the study interval measured using the Therapy Tracking Form
Secondary outcome measures
Adherence score for DBT booster sessions measured using a modified version of the Dialectical Behavior Therapy Adherence Checklist - Individual Therapy
Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)
Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Youth with and/or at familial risk for bipolar disorderExperimental Treatment1 Intervention
120 youth aged 14 to 24 with bipolar disorder (type I, type II, not otherwise specified/NOS) 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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Dialectical behavioral therapy

Find a site

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
340 Previous Clinical Trials
80,985 Total Patients Enrolled
13 Trials studying Bipolar Disorder
1,245 Patients Enrolled for Bipolar Disorder
Benjamin I Goldstein, MD, PhDPrincipal Investigator
Centre for Addiction and Mental Health
5 Previous Clinical Trials
176 Total Patients Enrolled
5 Trials studying Bipolar Disorder
176 Patients Enrolled for Bipolar Disorder

Media Library

Dialectical Behavioral Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05627492 — N/A
Bipolar Disorder Research Study Groups: Youth with and/or at familial risk for bipolar disorder
Bipolar Disorder Clinical Trial 2023: Dialectical Behavioral Therapy Highlights & Side Effects. Trial Name: NCT05627492 — N/A
Dialectical Behavioral Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05627492 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is the clinical trial currently enrolling?

"Correct. According to, this medical experiment was initially published on November 18th 2022 and is still recruiting patients today. Approximately 120 participants need to be enrolled from 1 particular site."

Answered by AI

What outcomes is this research endeavor attempting to demonstrate?

"The main aim of this study, which is to be assessed after a period of five years, is to calculate the number of Dialectical Behaviour Therapy sessions administered. Secondary goals involve monitoring frequencies via the Therapy Tracking Form, assessing coping skills with The DBT Ways Of Coping Checklist (DBT-WCCL), and gauging suicidality through the Suicidal Ideation Questionnaire (SIQ)."

Answered by AI

Is it possible for me to participate in this clinical research?

"This trial is seeking 120 adolescent and young adult participants between the ages of 14 and 25 with a diagnosis of manic disorder. To qualify, they must have taken part in either DB1 (049-2021) or DB3 (009-2021), possess native English fluency, meet diagnostic criteria for bipolar disorder as determined by KSADS-PL, be under the treatment of a CAMH psychiatrist, and if diagnosed with BD type I taking at least one mood stabilizing medication such antimanic anticonvulsant, antipsychotic or lithium. Furthermore these individuals should feel competent to provide informed consent/assent."

Answered by AI

Are geriatric patients being accepted into participation of this medical trial?

"This research is searching for individuals aged 14 to 25 years old."

Answered by AI

Are any slots available for participants in this medical experiment?

"Affirmative, the information on attests that this medical experiment is currently seeking volunteers. It was first uploaded to their website on November 18th 2022 and has been updated as recently as November 17th 2022. The researchers seek a total of 120 participants from one singular location."

Answered by AI
~80 spots leftby Nov 2027