Postpartum Screening for Anxiety and Comorbid Conditions

NCT ID: NCT06242717

Last Updated: 2024-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-09

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

None.
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, British Columbia

OTHER_GOV

Sponsor Role collaborator

Providence Healthcare

OTHER

Sponsor Role collaborator

St. Paul's Hospital, Canada

OTHER

Sponsor Role collaborator

University of Victoria

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Marianne Vidler

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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BC Women's Hospital & Health Centre

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Marianne Vidler, PhD, MSc

Role: CONTACT

604-875-2424 ext. 6474

Facility Contacts

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Marianne Vidler, PhD, MSc

Role: primary

604-875-2424 ext. 6474

Other Identifiers

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H22-03298

Identifier Type: -

Identifier Source: org_study_id

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