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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Must not have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow upsat the end of study completion (five years)

Awards & highlights

No Placebo-Only Group

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow ups ~ at the end of study completion (five years)

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dialectical behavioral therapy

2019

N/A

~40

Do I qualify?Apply below to find out

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 clinicaltrials.gov, 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 clinicaltrials.gov 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

Recent research and studies

clinicaltrials.govStudy

Pragmatic Patient-oriented 12-Month Extension Study of Dialectical Behavior Therapy Booster Sessions for Youth With and/or at Familial Risk for Bipolar Disorder

Benjamin Goldstein 2022. "Pragmatic Patient-oriented 12-Month Extension Study of Dialectical Behavior Therapy Booster Sessions for Youth With and/or at Familial Risk for Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05627492.