Results Summary and Professional Abstract
|This project's final research report is expected to be available by August 2021.|
Results of This Project
Preventing Postpartum Depression Closer to Home
This feature story looks at this study's examination of the Mothers and Babies Program, a cognitive behavioral therapy intervention focused on preventing postpartum depression.
Depression During and After Pregnancy Can Be Prevented, National Panel Says. Here’s How
New York Times, February 12, 2019
This Times feature highlights the US Preventive Services Task Force's February 2019 recommendation statement on preventing postpartum depression and two programs—including this project's Mothers and Babies program—that have successfully used a counseling approach for women with one or more of a broad range of risk factors.
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers noted the somewhat surprising study result that there were no differences between the two home visiting interventions: one using home visiting paraprofessionals and one using mental health professionals, and that these groups did not differ significantly from the usual care version of the home visiting intervention. The reviewers asked the researchers to discuss the potential reasons for the lack of differences in more detail. The researchers added a paragraph in their discussion enumerating the potential factors, including the overall mild level of depression severity among the study participants and the possibility that the usual care home visiting arm was more effective than typically noted in depression effectiveness studies. Additional potential reasons included the high nonadherence to treatment among participants in both intervention groups, and the competence of intervention facilitators, which were generally rated as satisfactory.
- The reviewers asked for clarification on the differences between the two groups who delivered interventions, classified as either home visiting paraprofessionals or mental health professionals, noting that it was unclear whether some of the former had advanced degrees or extensive experience delivering therapy or leading groups. The researchers provided more details on the characteristics of the home visiting paraprofessionals and mental health professionals in a table. The researchers noted that home visiting paraprofessionals with master’s degrees had them in fields not related to mental health. The researchers also said that past experience leading groups did not appear to affect client outcomes.
- The reviewers questioned why the researchers enrolled women already receiving therapy or medications for depression into the study. The researchers responded that in their experience, women who received counseling or medication were unlikely to be receiving high-quality counseling services or to continue treatment for very long, so the researchers felt it was reasonable and pragmatic to include women who were already receiving such treatments.
- The reviewers pointed out imbalances between the control group and test groups. For example, in the control arm, about 36 percent of participants were minorities, but the two test groups had nearly double that percentage of minorities. Also, employment rates and income varied between the control and test groups, and while seven states were represented in the study, only four states were represented in the home visiting paraprofessionals group. The reviewers asked whether these differences could have compromised the results. The researchers said that cluster randomized trials are prone to large imbalances like these despite randomization. The researchers noted that they were concerned particularly about potential imbalances in socioeconomic status and state or local program locations because even small imbalances could be meaningful. The researchers examined the outcomes after adjusting for intraprogram or intrasite correlations and found comparable results. Thus, the researchers concluded that they felt confident in their results.
- The reviewers asked why the researchers made the social support measure dichotomous, with a split at a score of four, rather than leaving it as a continuous variable. The researchers responded that the dichotomous measurement could account for the highly skewed scores, with almost 25 percent of respondents scoring a five, which was the highest score. The researchers stated that splitting the social support scores this way was the most meaningful option to understand the results.
- The reviewers asked how the modified intent-to-treat analyses used in this study differed from standard intent-to-treat analyses. The researchers explained that in standard intent-to-treat analyses, all participants who were randomized to a treatment group were included in analyses. In this study, however, 50 participants who were randomized but then provided no further data were not included in the analyses. The researchers said that the data were too limited for these participants to impute values for the primary outcome measure.
Conflict of Interest Disclosures
View the COI disclosure form.
Other Clinical Interventions
Other Health Services Interventions
Training and Education Interventions