← Back to all trials
Recruiting
NCT05691140
Prevention of Postpartum Anxiety in High-Risk Women
Conditions: Postpartum Anxiety
Sex: Female
Ages: 18 Years – N/A
Phase: NA
Enrollment: 30
Sponsor: St. Joseph's Healthcare Hamilton
Location: Canada
Summary
The primary aim of this study is to evaluate whether a CBT group designed to target IU (CBT-IU) in pregnant women with heightened levels of IU, prevents postpartum anxiety.
We hypothesize that women with clinically significant IU during pregnancy will exhibit both significant reductions in IU, as well as a decrease in anxiety symptoms postpartum, compared to a treatment as usual control group.
The secondary aim of this study is to evaluate whether CBT-IU significantly improves and/or prevents depression symptoms, worry symptom severity, and difficulties with emotion regulation.
We hypothesize that CBT-IU will lead to significant improvements in symptom severity compared to the treatment as usual control group.
Eligibility Criteria
Inclusion Criteria:Pregnant women (up to 30 weeks pregnant to allow for completion of the CBT-IU protocol before child delivery)18 years or olderBaseline score of ≥64 on the IUS (Furtado et al., 2021)No psychotropic medication or, if taking medication, no change in dose or type for a minimum of 6 weeks prior to baselineNo concurrent psychological treatmentFluent in English and able to consent for treatmentLocated in Ontario, CanadaExclusion Criteria:A current diagnosed DSM-5 anxiety disorder, as assessed by the Mini International Neuropsychiatric Interview (version 7.0.2)Active suicidal ideationCurrent psychosis or substance use disorderFor those enrolled on a stable dosage of a psychotropic medication, if a change in medication is required during the psychological therapy trial, the participant will continue with the therapy but will be excluded from the analysis.
Source: ClinicalTrials.gov (NCT05691140). StuddyBuddy aggregates publicly available trial information.