A Randomized Controlled Trial of the Feasibility and Acceptability of W-PPMA for Postpartum Mothers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 281
- 试验地点
- 2
- 主要终点
- Usage Rating Profile Intervention (URPI)-Feasibility
研究概览
简要总结
To evaluate the feasibility and acceptability of W-PPMA among a diverse group of postpartum mothers.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 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
排除标准
- •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
结局指标
主要结局
Usage Rating Profile Intervention (URPI)-Feasibility
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)