Results Summary
What was the research about?
Postpartum depression is a mental health problem that affects up to 20 percent of women after they have a baby. Women with postpartum depression may have trouble sleeping, feel anxious or sad, and have problems bonding with their babies. Postpartum depression is more common in women with low incomes than it is in women with high incomes.
In this study, the research team wanted to learn if adding a group therapy program called Mothers and Babies, or MB, to home visiting services could reduce depression symptoms. MB included six weekly group sessions given in a public location. Sessions focused on positive thinking, enjoying activities, and social support.
The research team also wanted to know if MB worked as well when community health workers, or CHWs, led sessions as when mental health providers led them. Mental health providers had advanced degrees in mental health; CHWs didn’t. Having CHWs provide MB may increase access to mental health care for moms.
What were the results?
After six months, women in MB and women with home visiting services alone had similar decreases in depression symptoms. They also didn’t differ in how likely they were to
- Have depression
- Be able to change their mood or behavior
- Know that sad thoughts would pass
- Feel like they had social support
MB groups led by CHWs weren’t better or worse at reducing depression symptoms than groups led by mental health providers.
Who was in the study?
The study included 824 women enrolled in 37 home visiting programs in seven midwestern states. Of these women, 44 percent were Black, 30 percent were White, 20 percent were Hispanic, 1 percent were Asian, less than 1 percent were Native American, and 4 percent were more than one race or ethnicity. The average age was 26, and 71 percent earned less than $25,000 a year.
What did the research team do?
The research team assigned each home visiting program to one of three groups by chance. The team assigned women to the same group as their home visiting program.
Women in all three groups received home visiting services. The services provided information about birth and caring for babies. One group also received MB led by mental health providers. The second group received MB led by CHWs. The third group received home visiting services alone.
Women filled out surveys at the start of the study, one week after MB ended, and again 12 and 24 weeks after their baby was born.
Mothers, counselors, patient advocates, policy makers, and community leaders gave input throughout the study.
What were the limits of the study?
Overall, women in this study had mild symptoms of depression when the study started. Results may have been different for women with severe depression.
Future research could look at whether women who have worse depression benefit more from MB.
How can people use the results?
Home visiting programs could use these results when considering ways to prevent and treat postpartum depression.
Professional Abstract
Objective
(1) To compare the effectiveness of adding the Mothers and Babies (MB) cognitive behavioral intervention to home visiting services versus home visiting services alone on reducing depressive symptoms in perinatal woman; (2) To determine whether community health workers (CHWs) provide MB as effectively as mental health professionals
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 824 perinatal women enrolled in home visiting programs |
| Interventions/ Comparators |
|
| Outcomes |
Primary: depressive symptoms Secondary: depressive episodes, behavioral activation, perceived social support, mood regulation, ability to recognize that troubling thoughts are temporary |
| Timeframe | 6-month postpartum follow-up for primary outcome |
This cluster-randomized study compared the effectiveness of adding MB to existing home visiting services on reducing depressive symptoms in perinatal women. MB included six weekly group sessions that took place at convenient public locations. Sessions focused on positive thinking, pleasant activities, and increasing social support. Researchers also examined whether CHWs delivered MB as effectively as mental health professionals. Mental health professionals had advanced degrees in mental health, while CHWs did not. Postpartum depression is more common among women with low incomes than it is in women with high incomes, and having CHWs lead interventions like MB may help more women access the care they need.
Researchers randomized home visiting programs to one of three groups and assigned perinatal women to the same group as their program. All groups received home visiting services, including education about childbirth and childrearing. One group also received MB led by mental health professionals. The second group received MB led by CHWs. The third group received home visiting services alone.
The study included 824 perinatal women enrolled in 37 home visiting programs in seven midwestern states. Of these women, 44% were Black, 30% were White, 20% were Hispanic,1% were Asian, less than 1% were Native American, and 4% were more than one race or ethnicity. The average age was 26, and 71% had incomes of less than $25,000 a year.
Women completed surveys at baseline, one week after the intervention ended, and again at 12 and 24 weeks postpartum.
Mothers, mental health professionals, patient advocates, policy makers, and community leaders provided input throughout the study.
Results
After six months, depressive symptom scores decreased overall across all three groups (95% confidence interval [CI]: 5.32, 6.00). Depressive symptom scores did not differ significantly across the three groups. Among the groups, women also did not differ significantly in depressive episodes, behavioral activation, perceived social support, mood regulation, or recognizing troubling thoughts as temporary.
Mean depressive symptom scores differed by 0.01 points, on a scale of 0-27, for women in the two MB groups at six months postpartum. As such, MB led by CHWs was not inferior to MB led by mental health professionals in reducing depressive symptoms.
Limitations
Overall, participants’ depressive symptom scores were in the mild range at baseline, limiting the MB program’s potential to reduce depressive symptoms.
Conclusions and Relevance
In this study, adding MB to home visiting services did not reduce depressive symptoms in perinatal women more than home visiting services alone. However, MB led by a CHW was not inferior to MB led by a mental health professional in reducing depressive symptoms.
Future Research Needs
Future research could explore if home visiting services plus MB are effective for women with moderate or severe depressive symptoms.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
Stories and Videos
PCORI Stories
Preventing Postpartum Depression Closer to Home
Media Mentions
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 Summary
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.