Clinical trial NCT06242717: Postpartum Screening for Anxiety and Comorbid Conditions
Official title: Postpartum Screening for Anxiety and Comorbid Conditions: A Prospective British Columbia Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postpartum Anxiety
Postpartum Depression
Postpartum Disorder
Postoperative Pain
Sleep Wake Disorders
Quality of Life
Anger
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Ministry of Health, British Columbia
name: Providence Healthcare
name: St. Paul's Hospital, Canada
name: University of Victoria
name: Stanford University
First posted: 2024-02-05
Enrollment: 550
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of postpartum people at 4-8 weeks after delivery.

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. 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

None.

Primary outcomes:
measure: Percentage of participants who completed surveys
timeFrame: 4-8 weeks postpartum
measure: Proportion of participants who consider usability of online surveys as being excellent (>85) with a System Usability Scale (SUS)
timeFrame: 4-8 weeks postpartum
Secondary outcomes:
measure: Number of participants with postpartum-related anxiety as assessed by the State-Trait Anxiety Inventory (STAI-S) and related predictors.
timeFrame: 4-8 weeks postpartum
measure: Number of participants with high postpartum-related anxiety and/or high risk for depression as assessed by validated questionnaires.
timeFrame: 4-8 weeks postpartum
measure: Number of participants with high postpartum-related anxiety and/or low social support as assessed by validated questionnaires.
timeFrame: 4-8 weeks postpartum
measure: Number of participants with high postpartum-related anxiety and/or high anger levels as assessed by validated questionnaires.
timeFrame: 4-8 weeks postpartum
measure: Number of participants with high postpartum-related anxiety and/or high levels of pain as assessed by validated questionnaires.
timeFrame: 4-8 weeks postpartum
measure: Number of participants with high postpartum-related anxiety and/or low quality of life as assessed by validated questionnaires.
timeFrame: 4-8 weeks postpartum
measure: Number of participants with high postpartum-related anxiety and/or poor sleep quality as assessed by validated questionnaires.
timeFrame: 4-8 weeks postpartum
measure: Number of participants with two or more comorbid comorbidities as described on outcome measures 4 to 9.
timeFrame: 4-8 weeks postpartum
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital & Health Centre
state: British Columbia
Study officials:
References: