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Behavioral Intervention

BRIDGE + Dialectical Behavioural Therapy for Depression (BRIDGE Trial)

N/A
Recruiting
Led By Leslie R. Roos, PhD
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at pre-intervention (t1), immediately after the intervention (t2), and at 6-month follow-up (t3).
Awards & highlights

BRIDGE Trial Summary

This trial tests whether a new intervention (BRIDGE) improves mental wellness and parenting of moms of 3-5 year-olds with elevated depression symptoms, compared to an established treatment and community services. Participants will complete questionnaires, assessments, and wear a Fitbit.

Who is the study for?
This trial is for English-speaking mothers in Manitoba or British Columbia, Canada, with children aged 3-5. Participants must have internet access and be willing to attend telehealth groups and complete questionnaires. They should have symptoms of depression but not a recent history of severe self-harm or certain mental health disorders unless cleared by a clinician.Check my eligibility
What is being tested?
The study tests the 'Building Regulation in Dual Generations (BRIDGE)' program against Dialectical Behavioural Therapy (DBT) skills training and usual community services. It measures if BRIDGE can reduce maternal depression and improve child mental health more effectively than other interventions over a 16-week period.See study design
What are the potential side effects?
Since this trial involves psychological therapy programs rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort when discussing personal issues during sessions.

BRIDGE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the phq-9 will be assessed during eligibility screening, pre-intervention (t1), immediately after the intervention (t2), and at 6-month follow-up (t3).
This trial's timeline: 3 weeks for screening, Varies for treatment, and the phq-9 will be assessed during eligibility screening, pre-intervention (t1), immediately after the intervention (t2), and at 6-month follow-up (t3). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in child mental illness symptoms
Change in depression symptoms
Secondary outcome measures
Change in Parenting stress
Change in harsh parenting
Other outcome measures
Change in alcohol use.
Change in anger.
Change in anxiety symptoms.
+30 more

BRIDGE Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Building Regulation in Dual Generations (BRIDGE; DBT + Parenting)Experimental Treatment1 Intervention
The BRIDGE program is a manualized therapy that provides participants with parenting and DBT skills through video training modules and in-group sessions. Participants in the BRIDGE arm will participate in 16 weeks of 20-30 minute DBT and parenting skills training that will be delivered asynchronously via video (participants will access these by logging onto a password protected website). The BRIDGE condition also includes weekly synchronous 1-hour virtual group therapy sessions as well as DBT and parenting skills worksheets to complete between sessions.
Group II: Dialectical Behavioural Skills Training (DBT)Active Control1 Intervention
Participants in the DBT arm will participate in 16 weeks of DBT skills training through weekly, synchronous 1.5-hour virtual group therapy sessions. Participants will also be asked to complete worksheets on the content between sessions.
Group III: Services-As-Usual (SAU)Active Control1 Intervention
Participants in the SAU arm will receive a list of local mental health and parenting resources, curated by our research team. Participants can access any intervention or resource participants would like throughout the duration of the program.

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor
595 Previous Clinical Trials
199,301 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,453,334 Total Patients Enrolled
5 Trials studying Postpartum Depression
1,188 Patients Enrolled for Postpartum Depression
Leslie R. Roos, PhDPrincipal InvestigatorUniversity of Manitoba

Media Library

Building Regulation in Dual Generations (BRIDGE) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05959538 — N/A
Postpartum Depression Research Study Groups: Building Regulation in Dual Generations (BRIDGE; DBT + Parenting), Dialectical Behavioural Skills Training (DBT), Services-As-Usual (SAU)
Postpartum Depression Clinical Trial 2023: Building Regulation in Dual Generations (BRIDGE) Highlights & Side Effects. Trial Name: NCT05959538 — N/A
Building Regulation in Dual Generations (BRIDGE) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05959538 — 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 have been approved to receive the experimental treatment?

"Yes, the information available on clinicaltrials.gov shows that this research is presently seeking participants for its experiment. This trial was initially posted on October 28th 2022 and most recently updated July 17th 2023; 180 individuals are being accepted at a single site."

Answered by AI

Is there still availability for potential participants in this clinical trial?

"According to clinicaltrials.gov, this particular trial is currently recruiting eligible participants. The listing was originally posted on October 28th 2022 and has since been revised as recently as July 17th 2023."

Answered by AI
Recent research and studies
~45 spots leftby Oct 2024