Results Summary
What was the research about?
Chronic pain lasts for months or years. People who have chronic pain often also have depression. Usual care for chronic pain and depression is mainly using medicines to treat symptoms.
In this study, the research team wanted to know if a group medical visit program with a focus on mind and body care would help patients with chronic pain and depression symptoms. During nine weekly group visits with a doctor, patients in the program learned about their health issues and ways to calm their minds and bodies using mindfulness and meditation. Patients in the program also received a computer tablet with lessons and an interactive feature to use at home. Patients who took part in the program continued to receive usual care from their primary care doctors, including treatment with medicines if needed.
The research team compared patients in the group medical visit program with patients who had usual care only.
What were the results?
During the course of the study, patients in the program and patients who had usual care only didn’t differ in their responses to surveys about their
- Pain symptoms
- Symptoms of depression
- Stress levels
- Sleep quality
- Misuse of pain medicines
Compared with patients who had usual care only, patients in the program
- Were less likely to use any pain medicines, including opioids
- Had better quality of life related to mental health
- Had worse quality of life related to physical health, but this difference may be explained by the number of patients in the program who had low back pain
At the time the group visits ended, patients in the program had fewer visits to the emergency room, or ER, compared with patients who had usual care only, but the two groups didn’t differ by the end of the study.
Who was in the study?
The study included 159 patients with chronic pain and depression symptoms. Patients received care at three health clinics serving low-income neighborhoods in Boston, Massachusetts. Of these patients, 56 percent were black, 30 percent were unknown race, 19 percent were white, and 6 percent were multiple races; 14 percent were Hispanic. The average age was 51, and 86 percent were women. In addition, 63 percent had a yearly income of less than $30,000.
What did the research team do?
The research team assigned patients, by chance, to be in the group medical visit program or to receive usual care only. The group medical visits were in person and lasted for two and a half hours.
Patients completed surveys when the study began and then again 9 weeks and 21 weeks later. The research team also looked at patients’ health records.
A group of patients gave input throughout the study.
What were the limits of the study?
Not everyone in the group medical visit program went to all of the visits. The results may have differed if more patients went to all of the visits. This study included patients in only one city. Results may differ in other locations or settings.
How can people use the results?
Health centers can use the results when considering how to help patients with chronic pain and depression reduce their use of pain medicines and ER visits.
Professional Abstract
Objective
To compare the effectiveness of an integrative medical group visit (IMGV) intervention with a control group in reducing pain and depressive symptoms for patients with chronic pain who live in low-income neighborhoods
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 159 patients with chronic pain and depressive symptoms who live in low-income neighborhoods |
| Interventions/ Comparators |
|
| Outcomes |
Primary: pain, depressive symptoms Secondary: pain medication use, mental and physical health–related quality of life, ED visits, pain self-efficacy, patient-perceived stress, sleep quality, risk of opioid misuse, patient activation |
| Timeframe | 21-week follow-up for primary outcomes |
This single-blind randomized controlled trial compared an IMGV intervention with usual primary care for patients with chronic pain who live in low-income neighborhoods to reduce pain and depressive symptoms and to increase their ability to manage pain.
Researchers randomly assigned patients to the IMGV group or to usual care only. The IMGV intervention included nine weekly, 2.5-hour, in-person group sessions with a physician facilitator that covered topics such as chronic pain, stress, insomnia, depression, and nutrition. Participants practiced mindfulness techniques, including meditation and chair yoga. They also received a computer tablet that had an e-health platform with an interactive component to support continued learning. Patients in both groups continued to receive usual care for chronic pain and depression, including pain medication if prescribed.
The study included 159 patients with self-reported chronic pain and depressive symptoms receiving care from two federally qualified health centers and one ambulatory clinic in an urban Boston, Massachusetts hospital. Of these, 56% were black, 30% were unknown race, 19% were white, and 6% were multiple races; 14% were Hispanic. The average age was 51, 86% were female, and 63% reported an annual income under $30,000.
Participants completed a survey at baseline, at 9 weeks when the group visits ended, and at 21 weeks when the maintenance phase ended. Researchers also reviewed medical records for emergency department (ED) visits.
A patient advisory group provided feedback throughout the study.
Results
In the quantitative analyses of survey results, the IMGV group and the control group did not show significantly different changes in self-reports of average pain in the past seven days or depressive symptoms.
Compared with the control group, the IMGV group
- Was less likely to use pain medication at the end of the study (odds ratio=0.42; 95% confidence interval [CI]: 0.18, 0.98)
- Showed a greater increase in mental health–related quality of life at the end of the study (relative risk [RR]=1.07; 95% CI: 1.01, 1.12)
- Had a greater decrease in physical health–related quality of life at the end of the study (RR=0.85; 95% CI: 0.77, 0.97), but this difference was no longer significant after controlling for low back pain
- Had a greater decrease in ED visits when weekly group visits ended (RR=0.31; 95% CI: 0.12, 0.83) but not at the end of the study
The two groups did not differ significantly on survey measures of pain self-efficacy, perceived stress, sleep quality, risk of opioid misuse, or patient activation.
Limitations
Some participants in the IMGV group did not attend all group sessions, which may have affected the effectiveness of the intervention. The study included patients from three health clinics in one city, limiting the generalizability of findings to other settings and locations.
Conclusions and Relevance
The IMGV intervention was not more effective than usual care at reducing pain and depressive symptoms for patients with chronic pain. It did provide some benefits, however, including greater reductions in pain medication use and ED visits.
Future Research Needs
Future studies could find ways to encourage attendance at all group sessions or could examine other ways to reduce pain and depression for patients with chronic pain.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
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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 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. The comments and responses included the following:
- The reviewers said that the report was unclear on whether the per-protocol analyses were preplanned, and what reported analyses were exploratory. This affected the reviewers’ comfort with the study’s original conclusions regarding the success of the integrated medical group visits (IMGV) compared to standard primary care visits. The researchers revised their analyses descriptions to specify what was pre-planned and what was exploratory. The researchers noted that they conducted much of the exploratory analyses based on the advice of patient and scientific advisors. The researchers also tempered their conclusions regarding the success of the IMGV since there was no significant difference in primary outcomes between the two treatment arms.
- Reviewers commented that it was unclear whether different components of the IMGV intervention, including mindfulness techniques and group visits, were meant to work independently, additively, or synergistically. The researchers replied that Figure 2 demonstrates the proposed mechanism of how different aspects of the intervention work, but the study was not designed to assess how well individual components work or whether they work in synergy.
- Reviewers noted that the study provided no information on the range of treatmentsthe usual care participants received and suggested that without better-defined mechanisms for treatment components, any differences observed could be due to the amount of attention participants received in the study. The researchers agreed that they did not collect important information on the control group, such as time spent with clinicians. They expanded on this in the limitations section.
- Reviewers noted that the researchers collected several measures of intervention uptake for the IMGV group, as well as measures on use of non-pharmacological treatments in the usual care group but did not use these data in analyses to help identify reasons for the null study findings. The researchers explained that they did not factor in non-pharmacological treatment changes because so many participants in the usual care group were already using non-pharmacological treatments when they started the study.