search
Back to results

Prevention of Postpartum Anxiety in High-Risk Women

Primary Purpose

Postpartum Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Joseph's Healthcare HamiltonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Behavioural Therapy

Treatment as Usual

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 10, 2023
Last Updated
April 11, 2023
Sponsor
St. Joseph's Healthcare Hamilton
search

1. Study Identification

Unique Protocol Identification Number
NCT05691140
Brief Title
Prevention of Postpartum Anxiety in High-Risk Women
Official Title
Prevention of Postpartum Anxiety in High-Risk Women: A Proof-of-Concept Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioural Therapy
Arm Type
Experimental
Arm Title
Treatment as Usual
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Cognitive Behavioural Therapy
Intervention Description
Cognitive Behavioural Therapy targeting Intolerance of Uncertainty
Primary Outcome Measure Information:
Title
Number of participants with principal anxiety disorder (as per DSM-5)
Description
Postpartum anxiety prevention will be defined as whether participants meet provisional DSM-5 diagnostic criteria for an anxiety disorder at the post-treatment assessments.
Time Frame
6-12 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Furtado, MSc, PhD (candidate)
Phone
905-522-1155
Ext
36369
Email
mfurtado@stjoes.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Sheryl M. Green, PhD, CPsych
Phone
905-522-1155
Ext
33672
Email
sgreen@stjoes.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheryl M Green, PhD, CPsych
Organizational Affiliation
St. Joseph's Healthcare Hamilton
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheryl M Green, PhD, CPsych

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28302701
Citation
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.
Results Reference
background
PubMed Identifier
34903196
Citation
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.
Results Reference
background
PubMed Identifier
19269536
Citation
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.
Results Reference
background
PubMed Identifier
30870771
Citation
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.
Results Reference
background
PubMed Identifier
11036732
Citation
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.
Results Reference
background
PubMed Identifier
22222208
Citation
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.
Results Reference
background

Learn more about this trial

Prevention of Postpartum Anxiety in High-Risk Women

We'll reach out to this number within 24 hrs