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Study protocol for the ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression
Jennifer E Johnson1, Amy M Loree2, Alla Sikorskii3
1Charles Stewart Mott Department of Public Health, Michigan State University College of Human Medicine, 200 East 1(st) St Room 366, Flint, MI 48502, United States of America.
Contemporary Clinical Trials
|July 20, 2023
Summary
This study compares universal versus selective postpartum depression (PPD) prevention programs for mothers. Universal prevention may offer greater scalability and equity than current risk-based approaches.
Area of Science:
- Reproductive Health
- Mental Health
- Implementation Science
Background:
- The United States Preventive Services Task Force recommends selective/indicated prevention for postpartum depression (PPD).
- Universal PPD prevention strategies may offer advantages in scalability, equity, and cost-benefit.
Purpose of the Study:
- To evaluate the Reach Out, Stay strong, Essentials for mothers of newborns (ROSE) program for postpartum depression (PPD) prevention.
- To compare universal PPD prevention with selective or indicated approaches.
- To assess effectiveness, cost-outcome, equity, scalability, and mechanisms of the ROSE program.
Main Methods:
- A large-scale trial will enroll 2320 pregnant individuals.
- Participants will be randomized to the ROSE program or enhanced usual care.
- The study will assess ROSE as universal, selective, and indicated prevention, analyzing effectiveness, cost-benefit, equity, scalability, and mechanisms.
Main Results:
- This trial is the first to directly compare universal, selective, and indicated PPD prevention strategies.
- It will provide insights into the scalability of PPD prevention programs, a critical area in implementation science.
Conclusions:
- The study's novel design efficiently compares different PPD prevention approaches.
- Findings will inform the optimal strategy for PPD prevention, considering effectiveness, cost, equity, and scalability.

