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Behavioral Intervention App for Postpartum Depression (eROSE Trial)
N/A
Recruiting
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial compares the InBloom app and the ROSE program for pregnant people at risk of postpartum depression. The InBloom app offers mental health support through a mobile application, while the ROSE program provides regular group sessions for education and support. The study aims to determine which method is more effective in reducing depression symptoms and improving satisfaction.
Who is the study for?
This trial is for pregnant individuals between 20-35 weeks along, who are at risk for postpartum depression. They must be English-speaking and receiving prenatal care at certain practices. Eligible participants may have a low income, anxiety or mild to moderate depressive symptoms during pregnancy, a history of depression treatment, gestational diabetes, or be aged 18-21.
What is being tested?
The study compares the effectiveness of two apps: InBloom and ROSE in preventing postpartum depression among pregnant people at risk. Participants will be randomly assigned to one of these interventions or control groups and followed from mid-pregnancy through three months after birth.
What are the potential side effects?
Since this trial involves behavioral interventions delivered via electronic apps rather than medications, traditional side effects are not expected. However, users might experience discomfort if sensitive topics are discussed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
mean depression severity measured using Patient Health Questionnaire (PHQ-9)
proportion of participants with post-partum depression assessed using the Mini International Neuropsychiatric Interview (MINI)
Secondary study objectives
Return on Investment (ROI)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: women receiving InBloom appExperimental Treatment1 Intervention
Group II: electronic health record utilization dataActive Control1 Intervention
We will leverage EHR utilization data by retrospectively identifying 152 people from the same clinics who did not receive ROSE or InBloom and matched for eligibility criteria, demographics and PPD risk factors using propensity scores, and comparing their utilization to those in the ROSE and InBloom groups.
Group III: women receiving ROSE as usualActive Control1 Intervention
Group IV: historical controls- no treatmentActive Control1 Intervention
We will capitalize on data from a large ROSE trial which consists of a demographically similar sample by comparing depression diagnosis outcomes for Inbloom and ROSE to the 96 participants in the care as usual group (an educational pamphlet on PPD).
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,936 Previous Clinical Trials
2,751,489 Total Patients Enrolled
20 Trials studying Postpartum Depression
7,722 Patients Enrolled for Postpartum Depression
University of RochesterLead Sponsor
872 Previous Clinical Trials
549,945 Total Patients Enrolled
3 Trials studying Postpartum Depression
95 Patients Enrolled for Postpartum Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have significant memory or thinking problems.I am between 17 and 32 weeks pregnant.I am under 18 years old.I am at risk for postpartum depression due to one or more factors like being on Medicaid, having anxiety or depression during pregnancy, a history of depression treatment, gestational diabetes, or being aged 18-21.I am unable to communicate in English.I plan to place my child for adoption.
Research Study Groups:
This trial has the following groups:- Group 1: electronic health record utilization data
- Group 2: women receiving InBloom app
- Group 3: women receiving ROSE as usual
- Group 4: historical controls- no treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.