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.
Professional Abstract
Objective
To determine whether a patient navigation intervention or a screening and referral intervention leads to greater patient satisfaction and improvement in depression symptoms or quality of life for women with socioeconomic disadvantage
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 223 women with symptoms of depression from a clinic primarily serving patients with socioeconomic disadvantage |
| Interventions/ Comparators |
|
| Outcomes |
Patient satisfaction with intervention, depression symptoms, quality of life |
| Timeframe | 10-month follow-up for study outcomes |
This study compared the effectiveness of two interventions: Personalized Support for Progress (PSP), a tailored patient navigation program, and Enhanced Screening and Referral (ESR), a program that systematically screened patients and facilitated referrals to community resources. Researchers randomly assigned participants to receive either PSP or ESR. Participants in the PSP group received assistance from a community health worker. Community health workers helped participants prioritize their needs and create personalized care plans. They then provided up to four months of outreach to support patients in implementing their care plan. Participants in the ESR group received a printed report about community resources for their identified needs, and assistance making appointments. The study coordinator conducted four monthly check-in calls with each ESR participant.
The study included 223 adult women who received care at three women’s health clinics in Rochester, New York. All participants had clinically significant depression symptoms. Of the 223 study participants, 61% were African American, 24% were white, and 19% were Hispanic. In addition, 73% of participants reported a household income of less than $20,000 per year, and 30% were pregnant at the time of enrollment. The mean age was 30.
Participants completed questionnaires at baseline, four months later when the intervention ended, and again three and six months postintervention.
The research team worked with a community advisory board of patient advocates, researchers, practitioners, policy makers, and others. The advisory board met regularly throughout the project to review study progress, recommend any needed protocol changes, and advise on implementation strategies.
Results
The team found minimal differences in patient satisfaction between the two groups, and participants in both groups were highly satisfied.
The PSP and ESR groups did not differ significantly in depression symptoms or quality of life. Depression symptoms improved over the course of the study for both groups and at similar rates. Quality of life did not change significantly for either group.
In a subgroup analysis, participants in the PSP group reported greater quality of life in some areas compared with participants in the ESR group. Subgroups who reported greater quality of life in the PSP program included participants with high anxiety (p=0.05), perceived lack of financial resources to afford depression treatment (p=0.02), high pain (p=0.04), and those who experienced intimate partner violence within the past year (p=0.02).
Limitations
This study included women receiving care from health clinics primarily serving socioeconomically disadvantaged populations in one geographic location. Study findings may not be generalizable to other areas or groups. The length of the treatment period was four months; results may be different in nonresearch settings where the intervention would likely be in place for a longer time.
Conclusions and Relevance
Patient satisfaction, depression symptoms, and quality of life were similar for participants in both groups. PSP may be more effective for women who experience intimate partner violence, pain, or anxiety in addition to depression symptoms.
Future Research Needs
Future studies could examine if the PSP and ESR interventions are effective at reducing depression symptoms in other populations and in other geographic locations or care settings and when compared with patients receiving usual care.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
Stories and Videos
PCORI Stories
To Fight Depression, Consider the Context
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.