Recruiting

Observational Study

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT05691140

Conditions

Postpartum Anxiety

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioural Therapy

Study Details

Brief 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. The investigators 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. The investigators hypothesize that CBT-IU will lead to significant improvements in symptom severity compared to the treatment as usual control group.

Conditions

Postpartum Anxiety

Study ID

NCT05691140

Start date

Oct 1, 2022

Status verified date

Apr, 2023

Completion date

Oct 1, 2024

Anticipated

Primary completion date

Oct 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pregnant women (up to 30 weeks pregnant to allow for completion of the CBT-IU protocol before child delivery)
  • 18 years or older
  • Baseline 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 baseline
  • No concurrent psychological treatment
  • Fluent in English and able to consent for treatment
  • Located in Ontario, Canada

Exclusion Criteria:

  • A current diagnosed DSM-5 anxiety disorder, as assessed by the Mini International Neuropsychiatric Interview (version 7.0.2)
  • Active suicidal ideation
  • Current psychosis or substance use disorder
  • For 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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cognitive Behavioural Therapy

no intervention: Treatment as Usual

Interventions

Cognitive Behavioural Therapy

Cognitive Behavioural Therapy targeting Intolerance of Uncertainty

Primary outcome measure

  • Number of participants with principal anxiety disorder (as per DSM-5) [ Time Frame: 6-12 weeks postpartum ]

Central Contacts and Locations

Central contacts

Melissa Furtado, MSc, PhD (candidate)

905-522-1155mfurtado@stjoes.ca

Sheryl M. Green, PhD, CPsych

905-522-1155sgreen@stjoes.ca

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Apr 14, 2023

Last verified

Apr, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2023-04-14.