Postpartum Screening for Anxiety and Comorbid Conditions

NCT06242717 | Recruiting

• 1 other identifier: H22-03298
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postpartum Anxiety; Postpartum Depression; Postpartum Disorder; Postoperative Pain; Sleep Wake Disorders; Quality of Life; Anger

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Number of participants with postpartum-related anxiety as assessed by the State-Trait Anxiety Inventory (STAI-S) and related predictors.

  4-8 weeks postpartum

• Number of participants with high postpartum-related anxiety and/or high risk for depression as assessed by validated questionnaires.

  4-8 weeks postpartum

• Number of participants with high postpartum-related anxiety and/or low social support as assessed by validated questionnaires.

  4-8 weeks postpartum

• Number of participants with high postpartum-related anxiety and/or high anger levels as assessed by validated questionnaires.

  4-8 weeks postpartum

• Number of participants with high postpartum-related anxiety and/or high levels of pain as assessed by validated questionnaires.

  4-8 weeks postpartum

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

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

Study Sites (1)

BC Women's Hospital & Health Centre

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum; Puerperal Disorders; Pain, Postoperative; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nervous System Diseases

Central Study Contacts

Marianne Vidler, PhD, MSc

CONTACT

604-875-2424; marianne.vidler@cw.bc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: February 5, 2024
• Study Start: November 9, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

CA (1)