W-PPMA for Postpartum Mothers

NCT05662605 | Terminated

• 1 other identifier: W-PPD-003
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postpartum Period

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• Patient Health Questionnaire (PHQ-8)

  Change from Baseline to End of Treatment at 8 weeks)

• Edinburgh Prenatal Depression Scale (EPDS)

  Change from Baseline to End of Treatment at 8 weeks

• Generalized Anxiety Disorder Questionnaire (GAD-7)

  Change from Baseline to End of Treatment at 8 weeks

• Perceived Stress Scale (PSS-10)

  Change from Baseline to End of Treatment at 8 weeks

Other Outcomes (3)

• Mother Infant Bonding Scale (MIBS)

  Change from Baseline to End of Treatment at 8 weeks

• Working Alliance Inventory (WAI-SR)

  Day 3 and End of Treatment at 8 weeks

• Feasibility, acceptability, perceptions of stigma as a barrier to mental health care, and mood outcomes across key sociodemographic variables of race and ethnicity, age, and level of education

  Baseline, Day 3 and End of Treatment at 8 weeks

Study Arms (2)

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.

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.

Interventions

W-PPMA DEVICE

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.

W-PPMA

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Woebot Health: lead
• Scripps Translational Science Institute: collaborator

Study Sites (1)

Scripps Translational Science Institute

La Jolla, California, 92037, United States

Location

Study Officials

• Lase Ajayi, MD

  Scripps Research Translational Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 22, 2022
• Study Start: February 22, 2023
• Primary Completion: January 18, 2024
• Study Completion: March 17, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)