Clinical trial NCT05662605: W-PPMA for Postpartum Mothers
Official title: A Randomized Controlled Trial of the Feasibility and Acceptability of W-PPMA for Postpartum Mothers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postpartum Period
Lead sponsor: Woebot Health
Sponsor class: INDUSTRY
Collaborators: name: Scripps Translational Science Institute
First posted: 2022-12-22
Enrollment: 281
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Usage Rating Profile Intervention (URPI)-Feasibility
timeFrame: End of Treatment (8 weeks from baseline)
measure: Usage Rating Profile Intervention (URPI)-Acceptability
timeFrame: End of Treatment (8 weeks from baseline)
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: End of Treatment (8 weeks from baseline)
measure: Number of active days in the W-PPMA application
timeFrame: Throughout treatment (from baseline to end of treatment at 8 weeks)
measure: Number of messages sent per week in the W-PPMA application
timeFrame: Throughout treatment (from baseline to end of treatment at 8 weeks)
measure: Number of modules completed in the W-PPMA application
timeFrame: Throughout treatment (from baseline to end of treatment at 8 weeks)
measure: Content satisfaction ratings in the W-PPMA application
timeFrame: Throughout treatment (from baseline to end of treatment at 8 weeks)
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: Change from Baseline to End of Treatment at 8 weeks)
measure: Edinburgh Prenatal Depression Scale (EPDS)
timeFrame: Change from Baseline to End of Treatment at 8 weeks
measure: Generalized Anxiety Disorder Questionnaire (GAD-7)
timeFrame: Change from Baseline to End of Treatment at 8 weeks
measure: Perceived Stress Scale (PSS-10)
timeFrame: Change from Baseline to End of Treatment at 8 weeks
Other outcomes:
measure: Mother Infant Bonding Scale (MIBS)
timeFrame: Change from Baseline to End of Treatment at 8 weeks
measure: Working Alliance Inventory (WAI-SR)
timeFrame: Day 3 and End of Treatment at 8 weeks
measure: 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
timeFrame: Baseline, Day 3 and End of Treatment at 8 weeks
Locations:
city: La Jolla
country: United States
facility: Scripps Translational Science Institute
state: California
Study officials:
affiliation: Scripps Research Translational Institute
name: Lase Ajayi, MD
role: PRINCIPAL_INVESTIGATOR
References: