Postpartum AnxietyPPANCT06242717
Postpartum Screening for Anxiety and Comorbid Conditions
An observational study of Postpartum Anxiety and Postpartum Depression, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Anxiety, Postpartum Depression, Postpartum Disorder
- How many people
- 550 participants
- Where
- 1 siteCanada
- Study dates
- 9 Nov 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A cohort of postpartum people at 4-8 weeks after delivery.
Who may be able to join
- ≥ 19 years
- 4-8 weeks postpartum
- Proficiency to participate in English
- Delivered within the province of British Columbia, Canada
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
BC Women's Hospital & Health Centre
Vancouver, British Columbia, V6H 3N1
Marianne Vidler, PhD, MSc, 604-875-2424 ext. 6474, marianne.vidler@cw.bc.ca
About this study
Official title: 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:
- State-Trait Anxiety Inventory
- Edinburgh Postnatal Depression Scale
- Multidimensional Scale of Perceived Social Support
- PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress-Anger, Short Form 5-a
- Short Form Brief Pain Inventory
- WHOQOL-BREF for assessing quality of life
- 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.
- Conditions
- Postpartum Anxiety, Postpartum Depression, Postpartum Disorder, Postoperative Pain, Sleep Wake Disorders, Quality of Life
- Medical subject headings
- Depression, Postpartum, Puerperal Disorders, Pain, Postoperative, Sleep Wake Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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".
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 4-8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start9 Nov 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum AnxietyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, British Columbia, Providence Healthcare, St. Paul's Hospital, Canada, University of Victoria, Stanford University
- Responsible party
- Principal investigator, Marianne Vidler, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242717
- Sponsor's protocol ID
- H22-03298
- Acronym
- PPA
- Status last verified
- Feb 2024
- First submitted
- 8 Nov 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Screening for Anxiety and Comorbid Conditions: A Prospective British Columbia Cohort Study
- ClinicalTrials.gov ID
- NCT06242717
- Acronym / sponsor ID
- PPA / H22-03298
- Conditions
- Postpartum Anxiety, Postpartum Depression, Postpartum Disorder, Postoperative Pain, Sleep Wake Disorders, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Ministry of Health, British Columbia, Providence Healthcare, St. Paul's Hospital, Canada, University of Victoria, Stanford University
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- State-Trait Anxiety Inventory
- Edinburgh Postnatal Depression Scale
- Multidimensional Scale of Perceived Social Support
- PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress-Anger, Short Form 5-a
- Short Form Brief Pain Inventory
- WHOQOL-BREF for assessing quality of life
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of postpartum people at 4-8 weeks after delivery.
Key inclusion criteria (4 listed)
- ≥ 19 years
- 4-8 weeks postpartum
- Proficiency to participate in English
- Delivered within the province of British Columbia, Canada
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of participants who completed surveys
Time frame: 4-8 weeks postpartum
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.
Proportion of participants who consider usability of online surveys as being excellent (>85) with a System Usability Scale (SUS)
Time frame: 4-8 weeks postpartum
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.
8 secondary outcomes
Number of participants with postpartum-related anxiety as assessed by the State-Trait Anxiety Inventory (STAI-S) and related predictors.
Time frame: 4-8 weeks postpartum
Number of participants with high postpartum-related anxiety and/or high risk for depression as assessed by validated questionnaires.
Time frame: 4-8 weeks postpartum
Number of participants with high postpartum-related anxiety and/or low social support as assessed by validated questionnaires.
Time frame: 4-8 weeks postpartum
Number of participants with high postpartum-related anxiety and/or high anger levels as assessed by validated questionnaires.
Time frame: 4-8 weeks postpartum
Number of participants with high postpartum-related anxiety and/or high levels of pain as assessed by validated questionnaires.
Time frame: 4-8 weeks postpartum
Number of participants with high postpartum-related anxiety and/or low quality of life as assessed by validated questionnaires.
Time frame: 4-8 weeks postpartum
Number of participants with high postpartum-related anxiety and/or poor sleep quality as assessed by validated questionnaires.
Time frame: 4-8 weeks postpartum
Number of participants with two or more comorbid comorbidities as described on outcome measures 4 to 9.
Time frame: 4-8 weeks postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Anxiety and Postpartum Depression, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marianne Vidler, PhD, MSc (604-875-2424 ext. 6474, marianne.vidler@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who completed surveys (time frame: 4-8 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.