Postpartum PeriodNCT05662605
W-PPMA for Postpartum Mothers
A study testing W-PPMA in people with Postpartum Period, run by Woebot Health at 1 site in United States.
Trial summary
To evaluate the feasibility and acceptability of W-PPMA among a diverse group of postpartum mothers. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postpartum Period
- What is being tested?
- W-PPMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2023to 17 Mar 2024
- Phase
- Interventional
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ≥ 16 years of age
- Be ≤ 3 month postpartum
- Currently enrolled in Scripps Research PowerMom study
- Own or have regular access to a smartphone (Android or iOS smartphone with a recent, supported operating system), that can receive SMS messages, and has reliable Wi-Fi access or sufficient data to engage with assigned treatment condition for the duration of the study
- Available and committed to engage with the program and complete assessments for a 16-week duration.
- Ability to read and understand English
Who cannot join
- Lifetime diagnosis of a psychotic disorder (including schizophrenia or schizoaffective disorder)
- Lifetime diagnosis of bipolar disorder
- Current suicidal ideation with a plan or intent or a suicidal attempt within the past 12 months
- History of (a) drug and/or alcohol abuse within the past 12 months
- Fetal demise within the past 18 months
- Previous use of the Woebot app
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Translational Science Institute
La Jolla, California, 92037
About this study
Official title: A Randomized Controlled Trial of the Feasibility and Acceptability of W-PPMA for Postpartum Mothers
To evaluate the feasibility and acceptability of W-PPMA among a diverse group of postpartum mothers.
Read the detailed description
This randomized waitlist-controlled trial evaluates the feasibility and acceptability of the W-PPMA digital health tool.
Participants will be recruited from the IRB-approved PowerMom research study of Scripps Research and, if interested, will complete screening for the sub-study. Eligible participants will be asked to provide informed consent and complete the baseline assessments. Those that do not meet eligibility criteria may resume their PowerMom experience.
Eligible participants will be randomized to one of two groups, W-PPMA or Waitlist, and will receive instructions on when and how they can access the digital health tool. Primary endpoints will be measured at 8-weeks (end of treatment) with additional measures being collected at 1- 4-, 8-, 12-, and 16-weeks (end of study). Screening, consenting, and outcome measures will be completed online through the MyDataHelps app.
- Conditions
- Postpartum Period
- Being tested
- W-PPMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
W-PPMADevice
W-PPMA is a digital health tool designed specifically for the postpartum experience and is accessed through a mobile application which delivers evidence-based therapy through brief "conversations" with a fully automated relational agent called Woebot.
| Study group | Role | What they receive |
|---|---|---|
| W-PPMA | Experimental | Participants randomized to this arm will have access to the W-PPMA mobile app throughout the 16-week study. Participants are asked to use the app for at least 5 minutes a day during the treatment phase (first 8 weeks) and then as often as they like during the follow-up phase (last 8 weeks) of the study. Receives: Device: W-PPMA |
| Waitlist | No intervention | Participants assigned to this group will not have access to the W-PPMA mobile app during the treatment phase (first 8 weeks) of the study. They will have access during the follow-up phase (last 8 weeks) of the study and will be instructed to use the app for at least 5 minutes a day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage Rating Profile Intervention (URPI)-Feasibility
Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Responses range from 1 = "slightly disagree" to 6 = "strongly agree". Scores are averages, with greater scores indicating greater intervention feasibility.
Measured: End of Treatment (8 weeks from baseline)
Usage Rating Profile Intervention (URPI)-Acceptability
Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Responses range from 1 = "slightly disagree" to 6 = "strongly agree". Scores are averages, with greater scores indicating greater intervention acceptability.
Measured: End of Treatment (8 weeks from baseline)
Client Satisfaction Questionnaire (CSQ-8)
An 8-item measure used to assess client's satisfaction with treatment on a 4-point scale (1 = "very dissatisfied" to 4 = "very satisfied"). Example questions include, "How would you rate the quality of service you received"? and "Did you get the kind of service you wanted?" Total sums range from 8-32, with high scores indicating greater satisfaction with the W-PPMA mobile application.
Measured: End of Treatment (8 weeks from baseline)
Number of active days in the W-PPMA application
Application engagement in the total number of active days using the application will be collected during the study to provide quantitative data regarding application utilization.
Measured: Throughout treatment (from baseline to end of treatment at 8 weeks)
Number of messages sent per week in the W-PPMA application
Application engagement in the number of messages sent each week within the application will be collected during the study to provide quantitative data regarding application utilization.
Measured: Throughout treatment (from baseline to end of treatment at 8 weeks)
Number of modules completed in the W-PPMA application
Application engagement in the number of modules completed within the application will be collected during the study to provide quantitative data regarding application content engagement.
Measured: Throughout treatment (from baseline to end of treatment at 8 weeks)
Content satisfaction ratings in the W-PPMA application
Application content satisfaction ratings will be collected during the study to provide quantitative data regarding application content engagement.
Measured: Throughout treatment (from baseline to end of treatment at 8 weeks)
Secondary outcomes (4)
Patient Health Questionnaire (PHQ-8)
An 8-item abbreviated version of the PHQ-9 used to assess mood and anxiety symptoms respectively. The PHQ-8 excludes an item assessing suicidality. Total score between 0-27, where higher scores indicate greater levels of depression.
Measured: Change from Baseline to End of Treatment at 8 weeks)
Edinburgh Prenatal Depression Scale (EPDS)
A 10-item self-report questionnaire used as a screening tool to identify patients who are at risk for perinatal depression. The scale assesses depression criteria including anhedonia, worry, and sleep disturbance, in the past seven days. Each item has four ordinal response options, yielding a total score of 0 to 30 such that higher scores indicate more severe symptoms.
Measured: Change from Baseline to End of Treatment at 8 weeks
Generalized Anxiety Disorder Questionnaire (GAD-7)
A 7-item brief self-report measure used to assess the frequency and severity of anxious thoughts and behaviors over the past 2 weeks. Total score between 0-21, where higher scores indicate greater levels of anxiety.
Measured: Change from Baseline to End of Treatment at 8 weeks
Perceived Stress Scale (PSS-10)
A 10-item self-reported questionnaire designed to measure the degree to which situations in one's life are appraised as stressful. Items comprising the PSS-10 assess the frequency of experiencing certain thoughts and feelings (e.g., feelings of upset, nervousness, a lack of control) over the past month. Each item is scored on a 5-point Likert scale from 0 (never) to 4 (very often); four positively stated items are reverse scored before summing all items to obtain the total score. Higher PSS scores indicate greater perceived stress.
Measured: Change from Baseline to End of Treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start22 Feb 2023
- Primary completion18 Jan 2024
- Study completion17 Mar 2024
Why it stopped: Internal company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum PeriodStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- None (open label)
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woebot Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Scripps Translational Science Institute
- Responsible party
- Sponsor
- Investigators
- Lase Ajayi, MD, Principal investigator, Scripps Research Translational Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662605
- Sponsor's protocol ID
- W-PPD-003
- Status last verified
- Apr 2024
- First submitted
- 21 Nov 2022
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Feasibility and Acceptability of W-PPMA for Postpartum Mothers
- ClinicalTrials.gov ID
- NCT05662605
- Acronym / sponsor ID
- W-PPD-003
- Conditions
- Postpartum Period
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Internal company decision
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Woebot HealthIndustry (pharma, biotech, devices)
- Collaborators
- Scripps Translational Science Institute
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 17 Mar 2024 (actual)
- First posted
- 22 Dec 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.
To evaluate the feasibility and acceptability of W-PPMA among a diverse group of postpartum mothers.
Detailed description
This randomized waitlist-controlled trial evaluates the feasibility and acceptability of the W-PPMA digital health tool.
Participants will be recruited from the IRB-approved PowerMom research study of Scripps Research and, if interested, will complete screening for the sub-study. Eligible participants will be asked to provide informed consent and complete the baseline assessments. Those that do not meet eligibility criteria may resume their PowerMom experience.
Eligible participants will be randomized to one of two groups, W-PPMA or Waitlist, and will receive instructions on when and how they can access the digital health tool. Primary endpoints will be measured at 8-weeks (end of treatment) with additional measures being collected at 1- 4-, 8-, 12-, and 16-weeks (end of study). Screening, consenting, and outcome measures will be completed online through the MyDataHelps app.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| W-PPMA | Experimental | Device: W-PPMAParticipants randomized to this arm will have access to the W-PPMA mobile app throughout the 16-week study. Participants are asked to use the app for at least 5 minutes a day during the treatment phase (first 8 weeks) and then as often as they like during the follow-up phase (last 8 weeks) of the study. |
| Waitlist | No intervention | –Participants assigned to this group will not have access to the W-PPMA mobile app during the treatment phase (first 8 weeks) of the study. They will have access during the follow-up phase (last 8 weeks) of the study and will be instructed to use the app for at least 5 minutes a day. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 16 years of age
- Be ≤ 3 month postpartum
- Currently enrolled in Scripps Research PowerMom study
- Own or have regular access to a smartphone (Android or iOS smartphone with a recent, supported operating system), that can receive SMS messages, and has reliable Wi-Fi access or sufficient data to engage with assigned treatment condition for the duration of the study
- Available and committed to engage with the program and complete assessments for a 16-week duration.
Key exclusion criteria (6 listed)
- Lifetime diagnosis of a psychotic disorder (including schizophrenia or schizoaffective disorder)
- Lifetime diagnosis of bipolar disorder
- Current suicidal ideation with a plan or intent or a suicidal attempt within the past 12 months
- History of (a) drug and/or alcohol abuse within the past 12 months
- Fetal demise within the past 18 months
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 |
|---|---|---|
| W-PPMAW-PPMA is a digital health tool designed specifically for the postpartum experience and is accessed through a mobile application which delivers evidence-based therapy through brief "conversations" with a fully automated relational agent called Woebot. | Device | W-PPMA |
Primary outcome
Usage Rating Profile Intervention (URPI)-Feasibility
Time frame: End of Treatment (8 weeks from baseline)
Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Responses range from 1 = "slightly disagree" to 6 = "strongly agree". Scores are averages, with greater scores indicating greater intervention feasibility.
Usage Rating Profile Intervention (URPI)-Acceptability
Time frame: End of Treatment (8 weeks from baseline)
Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Responses range from 1 = "slightly disagree" to 6 = "strongly agree". Scores are averages, with greater scores indicating greater intervention acceptability.
Client Satisfaction Questionnaire (CSQ-8)
Time frame: End of Treatment (8 weeks from baseline)
An 8-item measure used to assess client's satisfaction with treatment on a 4-point scale (1 = "very dissatisfied" to 4 = "very satisfied"). Example questions include, "How would you rate the quality of service you received"? and "Did you get the kind of service you wanted?" Total sums range from 8-32, with high scores indicating greater satisfaction with the W-PPMA mobile application.
Number of active days in the W-PPMA application
Time frame: Throughout treatment (from baseline to end of treatment at 8 weeks)
Application engagement in the total number of active days using the application will be collected during the study to provide quantitative data regarding application utilization.
Number of messages sent per week in the W-PPMA application
Time frame: Throughout treatment (from baseline to end of treatment at 8 weeks)
Application engagement in the number of messages sent each week within the application will be collected during the study to provide quantitative data regarding application utilization.
Number of modules completed in the W-PPMA application
Time frame: Throughout treatment (from baseline to end of treatment at 8 weeks)
Application engagement in the number of modules completed within the application will be collected during the study to provide quantitative data regarding application content engagement.
Content satisfaction ratings in the W-PPMA application
Time frame: Throughout treatment (from baseline to end of treatment at 8 weeks)
Application content satisfaction ratings will be collected during the study to provide quantitative data regarding application content engagement.
4 secondary outcomes
Patient Health Questionnaire (PHQ-8)
Time frame: Change from Baseline to End of Treatment at 8 weeks)
Edinburgh Prenatal Depression Scale (EPDS)
Time frame: Change from Baseline to End of Treatment at 8 weeks
Generalized Anxiety Disorder Questionnaire (GAD-7)
Time frame: Change from Baseline to End of Treatment at 8 weeks
Perceived Stress Scale (PSS-10)
Time frame: Change from Baseline to End of Treatment at 8 weeks
Results and safety
The study was stopped early (reason given: Internal company decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- 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.
Lase Ajayi, MD principal investigator
Scripps Research Translational Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing W-PPMA in people with Postpartum Period, run by Woebot Health at 1 site in United States.
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: stopped early, as of the sponsor's last update on 18 Apr 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 United States. 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?
The study was stopped early (reason given: Internal company decision). Results are not available in the source record.
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?
Usage Rating Profile Intervention (URPI)-Feasibility (time frame: End of Treatment (8 weeks from baseline)). 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?
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 18 Apr 2024.