Prevention of Postpartum Anxiety in High-Risk Women

Prevention of Postpartum Anxiety in High-Risk Women: A Proof-of-Concept Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Anxiety
• Intervention / Treatment: Other: Cognitive Behavioural Therapy

Detailed Description

Anxiety disorders are a serious mental health concern, affecting as many as 15-24% of women during the perinatal period. Despite the high prevalence of anxiety during the perinatal period and its associated impact, fewer than 15% of women receive treatment often due to difficulties in timely and accurate symptom detection. Our group conducted a longitudinal study that investigated the psychosocial and biological risk factors of postpartum anxiety worsening in a sample of high-risk pregnant women with pre-existing anxiety and depressive disorders. In this study, intolerance of uncertainty (IU) was identified as the strongest predictor. IU is a cardinal trait of anxiety and has been implicated in predicting treatment response in non-perinatal populations. However, despite the relevance of IU in anxiety disorders, our study was the first to assess IU in the perinatal population. As improving symptom detection through identification of significant risk factors, such as IU, can aid in the development of preventative and treatment measures, our group recently validated the Intolerance of Uncertainty Scale (IUS) in a perinatal population for the detection of anxiety disorders. In this study of 198 perinatal women, the IUS demonstrated excellent internal consistency and an optimal clinical cut-off score of 64 or greater was established, yielding a sensitivity of 89%. The IUS also demonstrated very good positive (79%) and negative (80%) predictive values. These findings suggest that the IUS represents a clinically useful screening tool to be used as an aid for the early and accurate detection of anxiety disorders during the perinatal period. Cognitive Behavioural Therapy (CBT) is considered a first-line treatment for perinatal anxiety disorders and CBT programs targeting IU have revealed promising findings in non-perinatal populations.It is therefore imperative to investigate whether a treatment program specifically designed to target IU during pregnancy can prevent postpartum anxiety.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa Furtado, MSc, PhD (candidate); Phone Number: 36369 905-522-1155; Email: mfurtado@stjoes.ca
• Study Contact Backup: Name: Sheryl M. Green, PhD, CPsych; Phone Number: 33672 905-522-1155; Email: sgreen@stjoes.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • Recruiting
      • St. Joseph's Healthcare Hamilton
      • Contact: Sheryl M Green, PhD, CPsych

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as Usual
Experimental: Cognitive Behavioural Therapy	Other: Cognitive Behavioural Therapy; Cognitive Behavioural Therapy targeting Intolerance of Uncertainty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with principal anxiety disorder (as per DSM-5)	Postpartum anxiety prevention will be defined as whether participants meet provisional DSM-5 diagnostic criteria for an anxiety disorder at the post-treatment assessments.	6-12 weeks postpartum

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Investigators: Principal Investigator: Sheryl M Green, PhD, CPsych, St. Joseph's Healthcare Hamilton

Publications and helpful links

General Publications

• Smith MV, Shao L, Howell H, Wang H, Poschman K, Yonkers KA. Success of mental health referral among pregnant and postpartum women with psychiatric distress. Gen Hosp Psychiatry. 2009 Mar-Apr;31(2):155-62. doi: 10.1016/j.genhosppsych.2008.10.002. Epub 2008 Dec 3.
• Dennis CL, Falah-Hassani K, Shiri R. Prevalence of antenatal and postnatal anxiety: systematic review and meta-analysis. Br J Psychiatry. 2017 May;210(5):315-323. doi: 10.1192/bjp.bp.116.187179. Epub 2017 Mar 16.
• Furtado M, Frey BN, Green SM. Validation of the intolerance of uncertainty scale as a screening tool for perinatal anxiety. BMC Pregnancy Childbirth. 2021 Dec 14;21(1):829. doi: 10.1186/s12884-021-04296-1.
• Furtado M, Van Lieshout RJ, Van Ameringen M, Green SM, Frey BN. Biological and psychosocial predictors of anxiety worsening in the postpartum period: A longitudinal study. J Affect Disord. 2019 May 1;250:218-225. doi: 10.1016/j.jad.2019.02.064. Epub 2019 Mar 1.
• Dugas MJ, Ladouceur R. Treatment of GAD. Targeting intolerance of uncertainty in two types of worry. Behav Modif. 2000 Oct;24(5):635-57. doi: 10.1177/0145445500245002.
• van der Heiden C, Muris P, van der Molen HT. Randomized controlled trial on the effectiveness of metacognitive therapy and intolerance-of-uncertainty therapy for generalized anxiety disorder. Behav Res Ther. 2012 Feb;50(2):100-9. doi: 10.1016/j.brat.2011.12.005. Epub 2011 Dec 21.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 13902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No