Postpartum Screening for Anxiety and Comorbid Conditions (PPA)

Postpartum Screening for Anxiety and Comorbid Conditions: A Prospective British Columbia Cohort Study

The goal of this project is to facilitate the design of individualized postpartum anxiety (PPA) screening strategies in British Columbia (BC), Canada. A cohort of postpartum people (n=550) will be invited to complete the following seven questionnaires at 4-8 weeks after delivery:

1. State-Trait Anxiety Inventory
2. Edinburgh Postnatal Depression Scale
3. Multidimensional Scale of Perceived Social Support
4. PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress-Anger, Short Form 5-a
5. Short Form Brief Pain Inventory
6. WHOQOL-BREF for assessing quality of life
7. PROMIS Sleep Disturbance Short Form 8-b and PROMIS Sleep-Related Impairment Short Form 8-a

The investigators will evaluate the feasibility of screening for postpartum anxiety and comorbid conditions through a web-based platform in a diverse BC population. They will assess the usability of the platform and questionnaires through 12-15 follow-up interviews with study participants and responses to the System Usability Scale. Their analysis will also identify patient characteristics and comorbidities (e.g., anger, pain, sleep disturbance) associated with a positive screen for postpartum anxiety.

Study Overview

• Status: Recruiting
• Conditions: Anger; Quality of Life; Sleep Wake Disorders; Postoperative Pain; Postpartum Depression; Postpartum Disorder; Postpartum Anxiety

• Study Type: Observational
• Enrollment (Estimated): 550

Contacts and Locations

• Study Contact: Name: Marianne Vidler, PhD, MSc; Phone Number: 6474 604-875-2424; Email: marianne.vidler@cw.bc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • Recruiting
      • BC Women's Hospital & Health Centre
      • Contact: Marianne Vidler, PhD, MSc; Phone Number: 6474 604-875-2424; Email: marianne.vidler@cw.bc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

A cohort of postpartum people at 4-8 weeks after delivery.

Description

Inclusion Criteria:

• ≥ 19 years
• 4-8 weeks postpartum
• Proficiency to participate in English
• Delivered within the province of British Columbia, Canada

Exclusion Criteria:

None.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants who completed surveys	The overall completion rate will be estimated as those completing (defined as >70% completion rate) the entire screening divided by those recruited and will be provided with a corresponding 95% confidence interval.	4-8 weeks postpartum
Proportion of participants who consider usability of online surveys as being excellent (>85) with a System Usability Scale (SUS)	Feasibility will be determined by study completion rates and usability will be determined by SUS / b) SUS items have a range of 0-4. SUS scores range from 0 to 100 providing an estimate of overall usability of the intervention. Scores above 70 are considered to be acceptable or good while scores of 85 or above indicate a high level of usability or excellent score. Scores of 50 or below indicate poor or unacceptable usability. SUS scores and time to completion will be summarized based on above thresholds.	4-8 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with postpartum-related anxiety as assessed by the State-Trait Anxiety Inventory (STAI-S) and related predictors.	A positive screen for anxiety will be determined using the validated questionnaire STAI (State-Trait Anxiety Inventory): 20-37 = No or Low Anxiety, 38-44 = "Moderate Anxiety", and 45-80 = "High Anxiety". / b) Possible predictors of a positive screen for anxiety will be initially assessed via summary statistics (e.g., mean differences or odds ratios) estimated via univariate regression models. / c) The investigators will assess the following predictors: Psychological risk factors: 1) "Past history of mood and/or anxiety disorders", 2) "Childhood abuse", 3) "Maternal sleep" / Biological risk factors: 1) "Proinflammatory T-helper cells and interleukins" / Obstetric and pregnancy-related factors: 1) "Difficult delivery", 2) "Negative obstetric outcomes", 3) "Current hyperemesis gravidarum", 4) "Breastfeeding" / Socio-demographic risk factors: 1) "Age", 2) "Marital status", 3) "Education level", 4) "Employment".	4-8 weeks postpartum
Number of participants with high postpartum-related anxiety and/or high risk for depression as assessed by validated questionnaires.	Common comorbidities that coincide with a positive screen for postpartum anxiety will be identified, as assessed by the STAI-validated questionnaire (as described in previous outcome measure) based on the responses to Edinburgh Postnatal Depression Scale (Range: 0-30, higher score: higher possibility of depression).	4-8 weeks postpartum
Number of participants with high postpartum-related anxiety and/or low social support as assessed by validated questionnaires.	Common comorbidities that coincide with a positive screen for postpartum anxiety will be identified, as assessed by the STAI-validated questionnaire (as described in previous outcome measure) based on the responses to Multidimensional Scale of Perceived Social Support Scale (Range: 12-84, lower score: lower social support).	4-8 weeks postpartum
Number of participants with high postpartum-related anxiety and/or high anger levels as assessed by validated questionnaires.	Common comorbidities that coincide with a positive screen for postpartum anxiety will be identified, as assessed by the STAI-validated questionnaire (as described in previous outcome measure) based on the responses to PROMIS Emotional Distress-Anger Short Form (5a, range: 5-25, higher score: more anger distress).	4-8 weeks postpartum
Number of participants with high postpartum-related anxiety and/or high levels of pain as assessed by validated questionnaires.	Common comorbidities that coincide with a positive screen for postpartum anxiety will be identified, as assessed by the STAI-validated questionnaire (as described in previous outcome measures) based on the responses to the Short Form Brief Pain Inventory Scale (Range: 0-120, higher score: higher pain severity).	4-8 weeks postpartum
Number of participants with high postpartum-related anxiety and/or low quality of life as assessed by validated questionnaires.	Common comorbidities that coincide with a positive screen for postpartum anxiety will be identified, as assessed by the STAI-validated questionnaire (as described in previous outcome measure) based on the responses to World Health Organization Quality of Life Scale (Range: 31-155, lower score: lower quality of life).	4-8 weeks postpartum
Number of participants with high postpartum-related anxiety and/or poor sleep quality as assessed by validated questionnaires.	Common comorbidities that coincide with a positive screen for postpartum anxiety will be identified, as assessed by the STAI-validated questionnaire (as described in previous outcome measure) based on the responses to PROMIS Sleep Disturbance (SF 8b) and Impairment (SF 8a) Scales (range: 16-80, higher score: more disturbed sleep).	4-8 weeks postpartum
Number of participants with two or more comorbid comorbidities as described on outcome measures 4 to 9.	Common comorbidities that coincide with a positive screen for postpartum anxiety will be identified, as assessed by the STAI-validated questionnaire (as described in previous outcome measure) based on the responses to validated questionnaires (as described in previous outcome measures). This will be done by estimating possible clusters of patients with commonalities. Cluster analysis based on hierarchical clustering will be conducted and assessed for internal validity via bootstrapping.	4-8 weeks postpartum

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Stanford University; University of Victoria; St. Paul's Hospital, Canada; Providence Healthcare; Ministry of Health, British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Mood Disorders; Neurologic Manifestations; Pregnancy Complications; Depressive Disorder; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sleep Wake Disorders; Anxiety Disorders; Depression, Postpartum; Puerperal Disorders
• Other Study ID Numbers: H22-03298

Drug and device information, study documents

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