Postpartum DepressionPhase 2SUPPORTNCT05382884
The SUPPORT Study: Effectiveness and Usability of a Web-Enabled Resource for Postpartum Mental Health
A Phase 2 study testing Postpartumcare.ca (Web-Enabled Intervention) in people with Postpartum Depression and Postpartum Anxiety, run by University of British Columbia at 1 site in Canada.
Trial summary
The SUPPORT Study aims to evaluate the effectiveness and usability of postpartumcare.ca, a web-enabled resource for postpartum depression (PPD) and postpartum anxiety (PPA), created based on the input of birthing parents in British Columbia (BC) affected by these disorders. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Postpartum Depression, Postpartum Anxiety, Postnatal Depression
- What is being tested?
- Postpartumcare.ca (Web-Enabled Intervention)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteCanada
- Study dates
- 20 Apr 2022to 1 May 2023
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have given birth within the past 12 months
- reside in British Columbia
- be at least 19 years of age
- have the ability to communicate in English
- have a suspected diagnosis or symptoms of postpartum depression and/or anxiety, as measured by the Edinburgh Depression Scale, having a score of 9 or greater and/or PASS score of 26 or greater, as measured as part of the initial eligibility questionnaire
- have access to study materials online, that is, have internet access and a device to access the internet, such as a computer or smartphone
Who cannot join
- have not given birth within the past 12 months
- reside outside of British Columbia
- under 19 years of age
- unable to communicate in English
- do not have a suspected diagnosis or symptoms of postpartum depression and/or anxiety, as measured by the Edinburgh Depression Scale, having a score of 8 or less and/or PASS score of 25 or less, as measured as part of the initial eligibility questionnaire
- do not have any internet access
Trial locations and contacts
1 site in 1 country.
Canada1 site
Women's Heath Research Institute
Vancouver, British Columbia, V6H 2N9
About this study
Official title: The SUPPORT Study: Survey and Development of a Universally Accessible Postpartum Online Resource for the Treatment of Postpartum Depression
The SUPPORT Study aims to evaluate the effectiveness and usability of postpartumcare.ca, a web-enabled resource for postpartum depression (PPD) and postpartum anxiety (PPA), created based on the input of birthing parents in British Columbia (BC) affected by these disorders.
Read the detailed description
This is Phase 3 of a multi-phase project that will be completed under the supervision of Dr. Lori Brotto, the University of British Columbia Sexual Health Lab and the Women's Health Research Institute at BC Women's Hospital.
The present study phase uses a randomized controlled trial design and will evaluate the effectiveness and usability of postpartumcare.ca using three outcomes: (1) depression and anxiety; (2) system usability and satisfaction; and (3) website metrics. Parents aged 19 or older experiencing postpartum depression and/or anxiety living in BC who gave birth in the past 12 months will be eligible. Fifty will be randomized to the intervention group, receiving immediate access to postpartumcare.ca for 4 weeks, and 50 will be assigned waitlist control, receiving treatment as usual.
Depression and anxiety symptoms will be measured at baseline, after the 4-week intervention period, and again 2 weeks later using the Edinburgh Postnatal Depression Scale (EPDS) and Perinatal Anxiety Screening Scale (PASS). After 4 weeks, system usability and satisfaction will be measured using the System Usability Scale (SUS), and website metrics will be collected for the intervention group only.
Multivariate analyses will be conducted to compare the anxiety and depression total scores and subscale scores between the two groups (intervention and treatment as usual). Descriptive analyses will be conducted on the satisfaction and usability questionnaires and website metrics.
The investigators hypothesize that following the use of postpartumcare.ca, the intervention group will see a greater reduction in depression and/or anxiety symptoms compared to the control group and that the website will be rated as usable.
The findings from this trial will add to the existing body of literature investigating the use of eHealth interventions for PPD and PPA treatment. Moreover, postpartumcare.ca will serve as a practical tool for birthing persons in BC in need of accessible and effective support.
- Conditions
- Postpartum Depression, Postpartum Anxiety, Postnatal Depression, Perinatal Disorder, Perinatal Depression, Postpartum Disorder
- Being tested
- Postpartumcare.ca (Web-Enabled Intervention)
- Keywords
- Postpartum Depression, Postpartum Anxiety, Perinatal, Postnatal, eHealth, Online Intervention, Website, Web-Enabled
- Medical subject headings
- Depression, Postpartum, Puerperal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartumcare.ca (Web-Enabled Intervention)Other
Postpartumcare.ca is a web-enabled intervention accessible via computer, tablet or smartphone devices. The content and design of postpartumcare.ca were created based on the needs, opinions, and desires of birthing parents in British Columbia affected by postpartum depression and/or anxiety, which were solicited previously in phases 1 \& 2 of the SUPPORT study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Fifty participants will be randomized to the intervention group, receiving immediate access to postpartumcare.ca for a period of 4 weeks. Intervention group participants may use postpartumcare.ca as often as desired for the duration of the 4-week intervention period. Following the 4-week intervention period and a 2-week follow-up period, intervention group participants will retain access to postpartumcare.ca. Receives: Other: Postpartumcare.ca (Web-Enabled Intervention) |
| Waitlist Control | No intervention | Fifty participants will be randomized to a waitlist control group, receiving treatment as usual (TAU) for a period of 4 weeks. Following the 4-week intervention period and a 2-week follow-up period, waitlist control participants will receive access to postpartumcare.ca. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Postpartum Depression at 4 weeks and 6 weeks, evaluated using the Edinburgh Postnatal Depression Scale (EPDS).
Changes in postpartum depression will be evaluated using the Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a standard scale used internationally to evaluate postpartum depression in the clinical setting and is recommended for screening of all postpartum parents who gave birth in British Columbia. Scoring on the EPDS ranges from 0 to 30, with higher scores indicating more severe depressive symptoms.
Measured: The EPDS will be administered at baseline, after a 4-week intervention period, and again after a 2-week follow up period
Change from Baseline Postpartum Anxiety at 4 weeks and 6 weeks, evaluated using the Perinatal Anxiety Screening Scale (PASS).
Changes in postpartum anxiety will be evaluated using the Perinatal Anxiety Screening Scale (PASS). The PASS is a commonly used measure for screening for anxiety in the perinatal period. Scoring on the PASS ranges from 0 to 93, with higher scores indicating more severe anxiety symptoms
Measured: The PASS will be administered at baseline, after a 4-week intervention period, and again after a 2-week follow up period
Website usability, as evaluated using the System Usability Scale (SUS)
Usability of the website intervention will be measured using a modified version of the System Usability Scale (SUS). The SUS is a reliable tool for measuring usability consisting of a 10-item questionnaire with 5 response options ranging from Strongly Agree to Strongly Disagree.
Measured: Website usability will be evaluated after the 4-week intervention period for the intervention group only
Website satisfaction, evaluated using the Patient Global Impression of Change (PGIC) questionnaire
Satisfaction with the website intervention will be measured using a brief Patient Global Impression of Change (PGIC) questionnaire developed for this study. the PGIC describes a participant's belief about the efficacy of treatment on a 7 point scale where change is rated as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse.".
Measured: Website satisfaction will be evaluated after the 4-week intervention period for the intervention group only
Website satisfaction, evaluated using the user-perceived web quality instrument
Satisfaction with the website intervention will be measured using the user-perceived web quality instrument. The user perceived web quality instrument is a 25-item instrument that measures four dimensions of web quality: specific content, content quality, appearance and technical adequacy.
Measured: Website satisfaction will be evaluated after the 4-week intervention period for the intervention group only
Website satisfaction, evaluated using the Patient Education Materials Assessment Tool (PEMAT)
Satisfaction with the website intervention will be measured using the Patient Materials Assessment Tool (PEMAT). The PEMAT evaluates and compares the understandability and actionability of patient education materials using a 26-item scale.
Measured: Website satisfaction will be evaluated after the 4-week intervention period for the intervention group only
Website metrics including average time on page, average session duration, returning visitors, and number of pages visited per session.
Website metrics describe how participants use the website intervention. Included website metrics will be average time on page, average session duration, returning visitors, and the number of pages visited per session. These metrics will be collected using Matomo Analytics.
Measured: Website metrics will be collected after the 4-week intervention period for the intervention group only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start20 Apr 2022
- Primary completion1 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study phase uses a randomized controlled trial design and will evaluate the effectiveness and usability of postpartumcare.ca. Fifty participants will be randomized to the intervention group, receiving immediate access to postpartumcare.ca for 4 weeks, and 50 will be assigned to a waitlist control group, receiving treatment as usual for the duration of the 4-week intervention period. Following the 4-week intervention period and 2-week follow-up, participants from both groups will be able to access postpartumcare.ca.
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Health Research Institute of British Columbia, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Lori Brotto, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382884
- Sponsor's protocol ID
- H21-03407
- Acronym
- SUPPORT
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lawrence CG, Breau G, Yang L, Hellerstein OS, Hippman C, Kennedy AL, Ryan D, Shulman B, Brotto LA. Effectiveness of a web-enabled psychoeducational resource for postpartum depression and anxiety among women in British Columbia. Arch Womens Ment Health. 2024 Dec;27(6):995-1010. doi: 10.1007/s00737-024-01468-8. Epub 2024 May 6.
PubMed 38709329
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SUPPORT Study: Survey and Development of a Universally Accessible Postpartum Online Resource for the Treatment of Postpartum Depression
- ClinicalTrials.gov ID
- NCT05382884
- Acronym / sponsor ID
- SUPPORT / H21-03407
- Conditions
- Postpartum Depression, Postpartum Anxiety, Postnatal Depression, Perinatal Disorder, Perinatal Depression, Postpartum Disorder
- Keywords
- Postpartum Depression, Postpartum Anxiety, Perinatal, Postnatal, eHealth, Online Intervention, Website, Web-Enabled
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Women's Health Research Institute of British Columbia, Canadian Institutes of Health Research (CIHR)
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 19 May 2022 (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 SUPPORT Study aims to evaluate the effectiveness and usability of postpartumcare.ca, a web-enabled resource for postpartum depression (PPD) and postpartum anxiety (PPA), created based on the input of birthing parents in British Columbia (BC) affected by these disorders.
Detailed description
This is Phase 3 of a multi-phase project that will be completed under the supervision of Dr. Lori Brotto, the University of British Columbia Sexual Health Lab and the Women's Health Research Institute at BC Women's Hospital.
The present study phase uses a randomized controlled trial design and will evaluate the effectiveness and usability of postpartumcare.ca using three outcomes: (1) depression and anxiety; (2) system usability and satisfaction; and (3) website metrics. Parents aged 19 or older experiencing postpartum depression and/or anxiety living in BC who gave birth in the past 12 months will be eligible. Fifty will be randomized to the intervention group, receiving immediate access to postpartumcare.ca for 4 weeks, and 50 will be assigned waitlist control, receiving treatment as usual.
Depression and anxiety symptoms will be measured at baseline, after the 4-week intervention period, and again 2 weeks later using the Edinburgh Postnatal Depression Scale (EPDS) and Perinatal Anxiety Screening Scale (PASS). After 4 weeks, system usability and satisfaction will be measured using the System Usability Scale (SUS), and website metrics will be collected for the intervention group only.
Multivariate analyses will be conducted to compare the anxiety and depression total scores and subscale scores between the two groups (intervention and treatment as usual). Descriptive analyses will be conducted on the satisfaction and usability questionnaires and website metrics.
The investigators hypothesize that following the use of postpartumcare.ca, the intervention group will see a greater reduction in depression and/or anxiety symptoms compared to the control group and that the website will be rated as usable.
The findings from this trial will add to the existing body of literature investigating the use of eHealth interventions for PPD and PPA treatment. Moreover, postpartumcare.ca will serve as a practical tool for birthing persons in BC in need of accessible and effective support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The present study phase uses a randomized controlled trial design and will evaluate the effectiveness and usability of postpartumcare.ca. Fifty participants will be randomized to the intervention group, receiving immediate access to postpartumcare.ca for 4 weeks, and 50 will be assigned to a waitlist control group, receiving treatment as usual for the duration of the 4-week intervention period. Following the 4-week intervention period and 2-week follow-up, participants from both groups will be able to access postpartumcare.ca.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Postpartumcare.ca (Web-Enabled Intervention)Fifty participants will be randomized to the intervention group, receiving immediate access to postpartumcare.ca for a period of 4 weeks. Intervention group participants may use postpartumcare.ca as often as desired for the duration of the 4-week intervention period. Following the 4-week intervention period and a 2-week follow-up period, intervention group participants will retain access to postpartumcare.ca. |
| Waitlist Control | No intervention | –Fifty participants will be randomized to a waitlist control group, receiving treatment as usual (TAU) for a period of 4 weeks. Following the 4-week intervention period and a 2-week follow-up period, waitlist control participants will receive access to postpartumcare.ca. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- have given birth within the past 12 months
- reside in British Columbia
- be at least 19 years of age
- have the ability to communicate in English
- have a suspected diagnosis or symptoms of postpartum depression and/or anxiety, as measured by the Edinburgh Depression Scale, having a score of 9 or greater and/or PASS score of 26 or greater, as measured as part of the initial eligibility questionnaire
Key exclusion criteria (6 listed)
- have not given birth within the past 12 months
- reside outside of British Columbia
- under 19 years of age
- unable to communicate in English
- do not have a suspected diagnosis or symptoms of postpartum depression and/or anxiety, as measured by the Edinburgh Depression Scale, having a score of 8 or less and/or PASS score of 25 or less, as measured as part of the initial eligibility questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postpartumcare.ca (Web-Enabled Intervention)Postpartumcare.ca is a web-enabled intervention accessible via computer, tablet or smartphone devices. The content and design of postpartumcare.ca were created based on the needs, opinions, and desires of birthing parents in British Columbia affected by postpartum depression and/or anxiety, which were solicited previously in phases 1 \& 2 of the SUPPORT study. | Other | Intervention |
Primary outcome
Change from Baseline Postpartum Depression at 4 weeks and 6 weeks, evaluated using the Edinburgh Postnatal Depression Scale (EPDS).
Time frame: The EPDS will be administered at baseline, after a 4-week intervention period, and again after a 2-week follow up period
Changes in postpartum depression will be evaluated using the Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a standard scale used internationally to evaluate postpartum depression in the clinical setting and is recommended for screening of all postpartum parents who gave birth in British Columbia. Scoring on the EPDS ranges from 0 to 30, with higher scores indicating more severe depressive symptoms.
Change from Baseline Postpartum Anxiety at 4 weeks and 6 weeks, evaluated using the Perinatal Anxiety Screening Scale (PASS).
Time frame: The PASS will be administered at baseline, after a 4-week intervention period, and again after a 2-week follow up period
Changes in postpartum anxiety will be evaluated using the Perinatal Anxiety Screening Scale (PASS). The PASS is a commonly used measure for screening for anxiety in the perinatal period. Scoring on the PASS ranges from 0 to 93, with higher scores indicating more severe anxiety symptoms
Website usability, as evaluated using the System Usability Scale (SUS)
Time frame: Website usability will be evaluated after the 4-week intervention period for the intervention group only
Usability of the website intervention will be measured using a modified version of the System Usability Scale (SUS). The SUS is a reliable tool for measuring usability consisting of a 10-item questionnaire with 5 response options ranging from Strongly Agree to Strongly Disagree.
Website satisfaction, evaluated using the Patient Global Impression of Change (PGIC) questionnaire
Time frame: Website satisfaction will be evaluated after the 4-week intervention period for the intervention group only
Satisfaction with the website intervention will be measured using a brief Patient Global Impression of Change (PGIC) questionnaire developed for this study. the PGIC describes a participant's belief about the efficacy of treatment on a 7 point scale where change is rated as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse.".
Website satisfaction, evaluated using the user-perceived web quality instrument
Time frame: Website satisfaction will be evaluated after the 4-week intervention period for the intervention group only
Satisfaction with the website intervention will be measured using the user-perceived web quality instrument. The user perceived web quality instrument is a 25-item instrument that measures four dimensions of web quality: specific content, content quality, appearance and technical adequacy.
Website satisfaction, evaluated using the Patient Education Materials Assessment Tool (PEMAT)
Time frame: Website satisfaction will be evaluated after the 4-week intervention period for the intervention group only
Satisfaction with the website intervention will be measured using the Patient Materials Assessment Tool (PEMAT). The PEMAT evaluates and compares the understandability and actionability of patient education materials using a 26-item scale.
Website metrics including average time on page, average session duration, returning visitors, and number of pages visited per session.
Time frame: Website metrics will be collected after the 4-week intervention period for the intervention group only
Website metrics describe how participants use the website intervention. Included website metrics will be average time on page, average session duration, returning visitors, and the number of pages visited per session. These metrics will be collected using Matomo Analytics.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 38709329Lawrence CG, Breau G, Yang L, Hellerstein OS, Hippman C, Kennedy AL, Ryan D, Shulman B, Brotto LA. Effectiveness of a web-enabled psychoeducational resource for postpartum depression and anxiety among women in British Columbia. Arch Womens Ment Health. 2024 Dec;27(6):995-1010. doi: 10.1007/s00737-024-01468-8. Epub 2024 May 6.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Postpartumcare.ca (Web-Enabled Intervention) in people with Postpartum Depression and Postpartum Anxiety, 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 10 May 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Postpartum Depression at 4 weeks and 6 weeks, evaluated using the Edinburgh Postnatal Depression Scale (EPDS). (time frame: The EPDS will be administered at baseline, after a 4-week intervention period, and again after a 2-week follow up period). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05382884, which also lists 1 linked publication.
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 10 May 2023.