W-PPMA for Postpartum Mothers
- Conditions
- Postpartum Period
- Interventions
- Device: W-PPMA
- Registration Number
- NCT05662605
- Lead Sponsor
- Woebot Health
- Brief Summary
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 281
- ≥ 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description W-PPMA W-PPMA 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.
- Primary Outcome Measures
Name Time Method Usage Rating Profile Intervention (URPI)-Feasibility 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 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.
Number of active days in the W-PPMA application 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.
Content satisfaction ratings in the W-PPMA application 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.
Client Satisfaction Questionnaire (CSQ-8) 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 messages sent per week in the W-PPMA application 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 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.
- Secondary Outcome Measures
Name Time Method Patient Health Questionnaire (PHQ-8) Change from Baseline to End of Treatment at 8 weeks) 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.
Edinburgh Prenatal Depression Scale (EPDS) Change from Baseline to End of Treatment at 8 weeks 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.
Generalized Anxiety Disorder Questionnaire (GAD-7) Change from Baseline to End of Treatment at 8 weeks 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.
Perceived Stress Scale (PSS-10) Change from Baseline to End of Treatment at 8 weeks 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.
Trial Locations
- Locations (1)
Scripps Translational Science Institute
🇺🇸La Jolla, California, United States