W-PPMA for Postpartum Mothers

Study Overview
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Brief Summary
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To evaluate the feasibility and acceptability of W-PPMA among a diverse group of postpartum mothers.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial of the Feasibility and Acceptability of W-PPMA for Postpartum Mothers

Conditions
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Postpartum Period

Intervention / Treatment
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* Device: W-PPMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 randomization
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: W-PPMA<br>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. | Device: W-PPMA<br>* 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.<br>|
| No Intervention: Waitlist<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Throughout treatment (from baseline to end of treatment at 8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Change from Baseline to End of Treatment at 8 weeks |