Results Summary
What was the research about?
Depression is a health problem that makes people feel sad, hopeless, or empty most days. Some women may have depression during pregnancy or after giving birth. Compared with other women, women with low incomes are more likely to feel depressed during or after pregnancy. Women with low incomes may also have a hard time getting mental health care.
In this study, the research team compared two ways to help pregnant women and new mothers with low incomes and symptoms of depression:
- Engagement-focused care coordination, or EFCC. Trained clinic staff met with women once or twice at the clinic to talk about their depression symptoms, learn about treatments, and consider which treatments might work best for them. Staff then helped women find mental health care outside of the clinic.
- Problem-solving education, or PSE. Trained clinic staff met with women six times at the clinic to help them learn to change patterns in their thinking to improve how they feel. If depression symptoms continued, staff connected these women with outside mental health services.
What were the results?
After one year, the programs didn’t differ in women’s improvement in overall depression symptoms. Women in both programs had improvement. Compared with women in the PSE program, women in the EFCC program reported larger declines in serious depression symptoms over one year and had larger declines in parenting stress.
The two programs didn’t differ in:
- Anxiety symptoms
- Knowledge, skill, and confidence about self-care
- Coping skills
- Ability to cope with life challenges
- Use of mental health services
- Children’s behavioral and emotional health
Who was in the study?
The study included 230 women who were pregnant or who had a child who was 18 months old or younger. Of the women, 60 percent were Black, 14 percent were White, 1 percent were Asian, and 24 percent were another race or more than one race. Also, 44 percent were Latina. The women were receiving care at Boston Medical Center. All had Medicaid insurance.
What did the research team do?
The research team assigned women to one of the two programs by chance. Women completed surveys every two months for one year.
Women who had depression after the birth of a child worked with the research team during the study.
What were the limits of the study?
Only about a third of women finished the programs. Results might have differed if more women had completed the programs. The study was conducted in a single medical center. Results may have differed if the study had been done at other locations.
Future research could compare the programs in other locations and look for ways to help more women complete the programs.
How can people use the results?
Health systems can use the results when considering ways to help manage depression symptoms for pregnant women and new moms with low incomes.
Professional Abstract
Objective
To compare the effectiveness of two strategies for improving depression symptoms among pregnant or postpartum women with low incomes
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 230 women ages 18 and older with depression symptoms who were receiving care at Boston Medical Center, had Medicaid, and were pregnant or had a child who is 18 months old or younger |
| Interventions/ Comparators |
|
| Outcomes |
Primary: depression symptoms Secondary: anxiety symptoms, behavioral activation, self-efficacy, coping skills, ability to cope with life challenges, parenting stress, child behaviors, engagement and retention with mental health services |
| Timeframe | 1-year follow-up for primary outcome |
This randomized controlled trial compared two programs for improving depression symptoms among pregnant and postpartum women with low incomes. Researchers randomly assigned women who screened positive for depression to one of two programs:
- Engagement-focused care coordination (EFCC). Trained clinic staff met one or two times with patients at the clinic. They used shared decision making and motivational interviewing techniques to help patients process their depression screening results, review treatment options, and connect with mental health services. EFCC focused on providing referrals to mental health services.
- Problem-solving education (PSE). Trained clinic staff facilitated a program of six weekly or biweekly cognitive behavioral therapy sessions. PSE focused on offering immediate intervention, followed by a referral to further treatment if symptoms persisted.
The study included 230 women attending Boston Medical Center’s prenatal clinic, pediatrics clinic, or newborn nursery. Of the participants, 60% were Black, 14% were White, 1% were Asian, and 24% identified as another race or more than one race; 44% were Latina.
Women in both groups completed questionnaires every two months.
Women who had depression after the birth of a child provided input on study design, data analysis, and interpretation of the findings.
Results
At one year, women in both programs had improvement in overall depression symptoms, but outcomes among women the two programs did not differ significantly. Compared with women in the PSE program, women in the EFCC program reported greater reductions in severe depression symptoms at one year (p<0.01) and in parenting stress over time (p<0.05). The programs did not differ significantly in how well they improved anxiety or other secondary outcomes.
Limitations
About two-thirds of study participants did not complete the full interventions. Attrition was more pronounced for women in the EFCC program. The study took place in a single medical center, which may limit the generalizability of the findings.
Conclusions and Relevance
In this study, both the EFCC program and the PSE program improved maternal depression over one year. The EFCC program was more effective at improving severe depression.
Future Research Needs
Future studies could compare the two programs at other hospitals and in other geographic areas and explore strategies to encourage more women to complete the programs.
COVID-19-Related Study
Summary
This study received additional funding in 2020 to quickly initiate new research related to COVID-19. The additional research is in progress. PCORI will post the research findings on this page once the results are final.
With this enhancement, the research team will address the health and social needs of families with low incomes during the pandemic. In the time of COVID-19, it may be hard for new mothers with low incomes to buy food or get health care for their babies. The research team will compare two programs with traditional services:
- A program that delivers food every week, including fruits, vegetables, and grains, versus delivery of $75 grocery store gift cards every two weeks
- A program that delivers mobile pediatric care versus on-site care
The research team will look at reports of food insecurity and whether babies received vaccines. Results will inform guidance on how to provide care to families with low incomes in the time of a pandemic.
Enhancement Award Amount: $500,000
Final Research Report
View this project's final research report.
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 asked for more information about the bachelor’s-trained care advocates in this study, noting that the report was inconsistent in the terminology used to refer to these individuals and it would be helpful for readers to understand their role better to determine whether these care advocates could fit into a variety of clinical settings. To provide greater clarity, the researchers renamed the care advocates “bachelor-level providers” and added information to the report regarding these providers’ training in depression care. The researchers also explained that they did not monitor care sessions closely because this was an effectiveness study; therefore, they wanted to test the intervention in the most real-world environment as possible.
- The reviewers were unclear on what the researchers considered an episode of depression since the Quick Inventory of Depression Symptomatology was measured at multiple intervals.
- The reviewers disagreed with the report’s conclusions that the Engagement-Focused Care Coordination intervention was preferable to the Problem Solving Education condition since the finding was mostly due to depression rates in the comparator group rather than changes in depression in the intervention group. The researchers revised their conclusions to point out the lack of differences between the two groups but felt that without a true control group they could not consider whether the continued presence of depressive symptoms among participants in both treatment groups meant that the treatments did not work.