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Behavioural Intervention
Cognitive Behavioural Therapy for Postpartum Anxiety
N/A
Recruiting
Led By Sheryl M Green, PhD, CPsych
Research Sponsored by St. Joseph's Healthcare Hamilton
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 6-12 weeks postpartum
Awards & highlights
Study Summary
This trial aims to see if a group therapy targeting IU (intense worry) during pregnancy can reduce postpartum anxiety. It also looks to see if it can improve depression, worry and emotion regulation.
Who is the study for?
This trial is for pregnant women up to 30 weeks along, who are experiencing high levels of uncertainty and anxiety. They must be over 18, fluent in English, not on changing doses of psychotropic meds or receiving other psychological treatments, and living in Ontario, Canada.Check my eligibility
What is being tested?
The study tests if Cognitive Behavioural Therapy (CBT) focused on intolerance of uncertainty (IU) can prevent postpartum anxiety. It compares the effects of this specialized CBT with usual treatment on anxiety, depression symptoms, worry severity, and emotion regulation after childbirth.See study design
What are the potential side effects?
Since the intervention involves therapy sessions without medication or invasive procedures, significant side effects are not expected. However, discussing emotional topics during therapy could temporarily increase distress.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-12 weeks postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-12 weeks postpartum
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with principal anxiety disorder (as per DSM-5)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Behavioural TherapyExperimental Treatment1 Intervention
Group II: Treatment as UsualActive Control1 Intervention
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Who is running the clinical trial?
St. Joseph's Healthcare HamiltonLead Sponsor
196 Previous Clinical Trials
25,514 Total Patients Enrolled
Sheryl M Green, PhD, CPsychPrincipal InvestigatorSt. Joseph's Healthcare Hamilton
1 Previous Clinical Trials
62 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am pregnant and less than 30 weeks along.I am currently having thoughts about harming myself.I haven't changed my mental health medication for at least 6 weeks.I am on a stable dose of mental health medication but understand I can be excluded from the study analysis if my medication changes.I am not currently receiving psychological therapy.I have been diagnosed with an anxiety disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Behavioural Therapy
- Group 2: Treatment as Usual
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project taking on any new participants?
"Clinicaltrials.gov reports that the recruitment process for this medical trial is ongoing, with initial postings having been made on October 1st 2022 and most recent updates being published as of January 10th 2023."
Answered by AI
What is the current cap on participants in this research effort?
"Affirmative. According to information found on clinicaltrials.gov, this study is currently seeking participants and was first published on October 1st 2022. The latest update occurred in January 10th 2023 and it requires 30 subjects from one medical centre alone."
Answered by AI
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