Results Summary

What was the research about?

When people are depressed, they feel sad, hopeless, or empty. Many people who live in neighborhoods with few resources have depression. They often face other life stressors, such as not having enough food or problems with relationships, personal safety, or housing.

In this study, the research team compared two programs designed to help women with feelings of depression who live in neighborhoods with few resources:

  • Patient navigation program. In this program, the research team matched women with a mentor from the community. Mentors helped each woman decide which of her needs to focus on and supported her in getting help for those needs.
  • Referral program. In this program, women received printed information about resources in the community. They also got help making appointments if needed. For example, the research team would offer to make an appointment with a therapist for a woman who reported mental health concerns.

The research team wanted to learn if women were more satisfied with one of the two programs. The team also wanted to know which program worked better to reduce feelings of depression and improve quality of life.

What were the results?

Women in both programs were very satisfied with their program. They liked the two programs about the same.

At the end of the study, feelings of depression and quality of life were similar for women in both programs. Both programs helped reduce feelings of depression. Overall, quality of life didn’t change for women in either program. But among women who had depression plus other problems such as anxiety or pain, the patient navigation program improved some aspects of quality of life more than the referral program.

Who was in the study?

The study included 223 adult women who reported symptoms of depression and received care at three health clinics in Rochester, New York. Of these women, 57 percent were African American, 21 percent were white, and 19 percent were Hispanic. Also, 73 percent had a household income of less than $20,000 per year, and 30 percent were pregnant when the study started. The average age was 30.

What did the research team do?

The research team assigned women by chance to either the patient navigation or referral program. Both programs lasted four months.

Women in the study completed questionnaires when the study began, when the programs ended, and then three and six months later. Questionnaires included questions about feelings of depression, quality of life, and how satisfied women in the study were with their program.

The team worked with an advisory group of patients, researchers, clinicians, policy makers, and others. The group gave feedback to help design and run the programs.

What were the limits of the study?

This study included women from three clinics in one city. Results might be different in other places. The programs lasted for four months. Four months may not have been long enough for quality of life to improve.

Future research could see if these two programs could help women with depression in other neighborhoods with few resources.

How can people use the results?

Health centers that serve women from neighborhoods with few resources may consider using either a patient navigation program or a referral program to help women with depression. Women with depression plus problems such as anxiety or pain may find a patient navigation program more helpful than a referral program.

Final Research Report

View this project's final research report.

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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 confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not 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 how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer-review process here.

In response to peer review, the PI made changes including

  • Providing more information on the involvement and activities of the Community Advisory Board and the National Advisory Board, and how those activities impacted the study.
  • Clarifying the reasons for choosing ANCOVA as the primary analytic strategy, and using growth-curve modeling with the same covariates for sensitivity analyses because the study was not powered to use growth curve modeling as the primary strategy. The researchers noted that the sensitivity analyses support the main results for Aims 1 and 2, about which reviewers had raised concerns in the initial draft of the report. Per reviewers’ recommendations, the researchers also commented on the lack of sufficient power to use the growth curve modeling for intervention by time interactions as a study limitation.
  • Conducting multiple imputation to account for missing data. The researchers initially considered multiple imputation as unnecessary since the low rate of missing data for both intervention and control groups would indicate that missing data was unlikely to explain the study results. The researchers noted that these analyses had shown non-significant results for all main outcomes.
  • Indicating that the analyses for Aim 3, which focused on the heterogeneity of treatment effects, were considered exploratory. The researchers revised the report to provide all outcomes that were measured in these analyses, and explained why they did not correct the indicators of statistical significance for multiple comparisons.
  • Explaining that women currently engaged in behavioral health treatment were included in the study because the researchers assumed that randomization would minimize any potential group differences in experience with such treatment. Per the reviewers’ recommendations, the researchers added information about behavioral health treatment involvement for the sample, adding the lack of consistent information about the use of behavioral interventions to the study Limitations.
  • Revising the Results and Discussion sections so that they focus more on the main and exploratory outcomes, moving secondary outcomes to an appendix. Per reviewer recommendations, the researchers also revised the statements made in these sections to remove any that were not supported by the study findings or may have overstated the significance of the findings.

Conflict of Interest Disclosures

Project Information

Ellen Poleshuck, PhD
University of Rochester
$1,947,894
10.25302/5.2019.AD.12114261
Patient Priorities and Community Context: Navigation for Disadvantaged Women with Depression

Key Dates

May 2013
August 2017
2013
2018

Study Registration Information

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Last updated: January 25, 2023