Prevention of Postpartum Anxiety in High-Risk Women

NCT05691140 | Unknown

• 1 other identifier: 13902
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cognitive Behavioural Therapy

EXPERIMENTAL

Other: Cognitive Behavioural Therapy

Treatment as Usual

NO INTERVENTION

Interventions

Cognitive Behavioural Therapy OTHER

Cognitive Behavioural Therapy targeting Intolerance of Uncertainty

Cognitive Behavioural Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women (up to 30 weeks pregnant to allow for completion of the CBT-IU protocol before child delivery)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

RECRUITING

Related Publications (8)

• 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.

  PMID: 28302701 BACKGROUND

• 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.

  PMID: 34903196 BACKGROUND

• 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.

  PMID: 19269536 BACKGROUND

• 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.

  PMID: 30870771 BACKGROUND

• 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.

  PMID: 11036732 BACKGROUND

• 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.

  PMID: 22222208 BACKGROUND

• Furtado M, Frey BN, Inness BE, McCabe RE, Green SM. Targeting Intolerance of Uncertainty During Pregnancy: A Randomized Controlled Trial to Prevent Postpartum Anxiety Disorders. J Clin Psychiatry. 2025 Nov 5;87(1):25m15979. doi: 10.4088/JCP.25m15979.

  PMID: 41190888 DERIVED

• Furtado M, Frey BN, Inness BE, McCabe RE, Green SM. Cognitive behavioural therapy for intolerance of uncertainty: A study protocol for the prevention of postpartum anxiety. J Reprod Infant Psychol. 2025 Apr 29:1-20. doi: 10.1080/02646838.2025.2495928. Online ahead of print.

  PMID: 40297898 DERIVED

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sheryl M Green, PhD, CPsych

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Furtado, MSc, PhD (candidate)

CONTACT

905-522-1155; mfurtado@stjoes.ca

Sheryl M. Green, PhD, CPsych

CONTACT

905-522-1155; sgreen@stjoes.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist, Principal Investigator

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)