W-PPMA for Postpartum Mothers

Woebot Health

Status: Terminated

Conditions: Postpartum Period

Treatments: Device: W-PPMA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05662605

W-PPD-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 281 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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281 participants in 2 patient groups

W-PPMA

Experimental group

Description:

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.

Treatment:

Device: W-PPMA

Waitlist

No Intervention group

Description:

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.