An interventional study of Integrative Medicine Group Visits in Chronic Pain and Depression, sponsored by Boston Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by Boston Medical Center · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether Integrative Medicine Group Visits (IMGV) are effective for treating patients with chronic pain and depression.
The investigators propose a randomized controlled comparative effectiveness trial for patients from predominantly low-income minority backgrounds with chronic pain and depressive symptoms comparing two treatment groups: (1) A standardized, 9-session Integrative Medicine Group Visits (IMGV) protocol; (2) primary care visits including medications and provider's advice. The trial will take place at three sites: Boston Medical Center's Family Medicine Center and two affiliated federally qualified community health centers.
Patients at the three sites can self-refer or with their permission, their clinician can forward their information via email, an electronic flag or phone call to research staff. Following verbal consent, patients will be screened for eligibility by a Research Assistant either over the phone or in person. Eligible participants will then have the study explained to them by the Research Assistant and will be offered an opportunity to ask questions about the study and then invited to provide informed consent. Those participants who consent to participate will provide contact information for themselves and two additional contacts to assist with follow-up. They will then complete the baseline data survey which will consist of questionnaires on topics such as stress, pain, sleep, self-efficacy, social support, diet, exercise, relaxation, and use of pain medications. These will be administered on a tablet by a Research Assistant and should take no more than one hour to complete. Once the baseline measures have been completed, participants will be randomized to either the intervention or control condition. Once randomized, participants' clinicians will be notified via phone call, letter or email that their patient is enrolled in the study.
INTERVENTION GROUP Integrative Medicine Group Visits (IMGV)
The intervention is adapted from Mindfulness Based Stress Reduction (MBSR). For this study, those randomized to the intervention group will be asked to attend nine consecutive group visits (once a week) and a follow-up group visit at 12 weeks after the last session. During the session, a physician and co-leader facilitate each groups. Participants are taught and practice relaxation techniques at each class. The physician facilitates a discussion on health topics important to the group participants on chronic disease management, such as prevention and management of pain and associated conditions (stress re-activity, insomnia, obesity, hypertension etc.). Patients are also introduced to evidenced based complementary activities such as self-massage techniques, acupressure, and cooking classes. Finally, an optional healthy meal is served each week, creating an opportunity to model healthy nutrition and build community. Individuals randomized to IMGV will continue to receive routine medical care, including pain medications, from their primary care providers (PCPs).
Individual time spent with the group visit physician - Depending on the individual patient and his/her needs. The IMGV physician facilitator will communicate with the participants' PCPs (via electronic medical record or phone) throughout the intervention to give updates on the activities and progress of the patients.
To establish the internal validity of IMGV a research assistant will monitor the groups. An evaluation checklist of key components of the group visit will be used to assure internal validity and standardization of group IMGV curriculum across all three sites.
COMPANION WEB-BASED HOMEWORK/ HOME PRACTICE
The website serves several functions: 1) by putting all the patient materials online, it gives all patients regardless of study site the opportunity to track their health progress, participate in a monitored discussion group, and have access to audio and visual materials from class. At home, participants will complete their homework online which includes: accessing video or audio exercises or watching provider talks, which reinforce key content from the groups. 2) Our research team will use the website to track the length of time and frequency that patients practice self-care exercises at home, as well as which portions of the site the participant visits. Another component of the website is access to a Virtual Patient Advocate (VPA). The VPA will deliver a menu of mind-body activities and nutrition advice that mirrors the content of the IMGV groups.
Intervention participants will receive reminder calls each week prior to their IMGV from study staff, just as they would for other medical visits. If a participant does not attend an IMGV session, a research assistant will call to find out why they have missed the session and to remind them of the importance of attending as many sessions as possible. They will also receive letters/emails to remind them to log in to the website on a weekly basis and a letter/email to remind them about the final, follow-up session.
Control Group
Patients randomized to the control group will be given access to IMGV if desired in a non-study context at the completion of their data collection at 21 weeks (i.e., wait list control). Access to primary care providers is our control group (an approximately 15-minute usual care visit with MD, nurse practitioner (NP), physician assistant (PA) - prescribing medications, advice, standard of care recommendations).
Nine weeks after study enrollment control participants will receive a request to complete a follow-up survey which will measure the same items as the baseline survey with the exception of the demographic information and health literacy information. Finally, 21 weeks after study enrollment for the controls, participants will be asked to complete a second follow-up survey. Both follow-up surveys will be administered on a tablet by a research assistant, preferably in person, but by phone if a participant prefers.
2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.
This study's enrollment of 159 is above the median of 60 across 2,209 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
9-week integrative medicine group visit that meets 1 time per week for 2.5 hours followed by a 3 month Web based curriculum and final group meeting
Behavioral: Integrative Medicine Group Visits
primary care visits, which include medications and advice
Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum.
Chronic Pain
Chronic pain reflects the average scores for the severity, interference and average pain subscales from the Brief Pain Inventory (BPI) Short Form (BPI-sf). BPI-sf is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on their daily functioning on a 10 point scale from 0 to 10 where higher scores indicate higher levels of pain. Average pain was obtained by asking the participant's what their average pain was in the past 7 days. Pain interference was calculated by adding the scores for questions 8a, b, c, d, e, f, and g and then dividing by seven. Pain severity was calculated by adding the scores for questions 2, 3, 4, and 5 and then by dividing by four. The average score for each subscale was obtained by adding all respective scores and then dividing each subscale total by the total number of participants.
Time frame: This was conducted at 21 weeks.
Depression
Patient Health Questionnaire (PHQ-9) measures severity of depressive symptoms. It is a sum of 9 items each with a 0-3 units on a scale. Higher scores indicate higher levels of depression. A score of 0-4 is considered minimal or none in depression severity. A score of 5-9 is considered mild in depression severity. A score of 10-14 is considered moderate in depression severity. A score of 15-19 is considered moderately severe in depression severity. A score of 20-27 is considered severe in depression severity. (Kroenke 2009) This was conducted at 21 weeks.
Time frame: This was conducted at 21 weeks.
Pain Self Efficacy Scale
Pain Self Efficacy Questionnaire (PSEQ) - used to assess the confidence in performing activities while in pain. It is the sum of 10 items each with a 0-6 scale. Scores range from 0-60 and is done by simple addition. Higher scores indicate higher levels of confidence. (Nicholas 2007) This was conducted at 21 weeks.
Time frame: This was conducted at 21 weeks.
Pain Medication Use
Number of participants reported pain medication in the past seven day. This was obtained at 21 weeks.
Time frame: This was conducted at 21 weeks.
Emergency Department Use
Number of emergency room visits based on chart review data collection.
Time frame: This was collected at 21 weeks.
| Milestone | Integrative Medical Group Visits | Standard of Care |
|---|---|---|
| Started | 80 | 79 |
| Completed | 68 | 73 |
| Not completed | 12 | 6 |
| Withdrew: Lost to follow-up | 5 | 6 |
| Withdrew: Found ineligible after enrollment | 3 | 0 |
| Withdrew: Withdrawal by subject | 4 | 0 |
Chronic pain reflects the average scores for the severity, interference and average pain subscales from the Brief Pain Inventory (BPI) Short Form (BPI-sf). BPI-sf is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on their daily functioning on a 10 point scale from 0 to 10 where higher scores indicate higher levels of pain. Average pain was obtained by asking the participant's what their average pain was in the past 7 days. Pain interference was calculated by adding the scores for questions 8a, b, c, d, e, f, and g and then dividing by seven. Pain severity was calculated by adding the scores for questions 2, 3, 4, and 5 and then by dividing by four. The average score for each subscale was obtained by adding all respective scores and then dividing each subscale total by the total number of participants.
| units on a scale | Integrative Medicine Group Visits | Standard of Care-Control |
|---|---|---|
| 21 week Average pain | 6.0 ± 2.0 | 6.0 ± 2.0 |
| 21 week BPI Interference | 6.0 ± 2.7 | 5.0 ± 2.7 |
| 21 week BPI Severity | 6.0 ± 2.3 | 6.0 ± 2.0 |
Patient Health Questionnaire (PHQ-9) measures severity of depressive symptoms. It is a sum of 9 items each with a 0-3 units on a scale. Higher scores indicate higher levels of depression. A score of 0-4 is considered minimal or none in depression severity. A score of 5-9 is considered mild in depression severity. A score of 10-14 is considered moderate in depression severity. A score of 15-19 is considered moderately severe in depression severity. A score of 20-27 is considered severe in depression severity. (Kroenke 2009) This was conducted at 21 weeks.
| units on a scale | Integrative Medicine Group Visits | Standard of Care-Control |
|---|---|---|
| Depression | 9.32 ± 5.42 | 10.15 ± 5.88 |
Pain Self Efficacy Questionnaire (PSEQ) - used to assess the confidence in performing activities while in pain. It is the sum of 10 items each with a 0-6 scale. Scores range from 0-60 and is done by simple addition. Higher scores indicate higher levels of confidence. (Nicholas 2007) This was conducted at 21 weeks.
| units on a scale | Integrative Medicine Group Visits | Standard of Care-Control |
|---|---|---|
| Pain Self Efficacy Scale | 34 ± 14.7 | 38 ± 13.5 |
Number of participants reported pain medication in the past seven day. This was obtained at 21 weeks.
| Participants | Integrative Medicine Group Visits | Standard of Care-Control |
|---|---|---|
| Pain Medication Use | 49 | 60 |
Number of emergency room visits based on chart review data collection.
| participants | Integrative Medicine Group Visits | Standard of Care-Control |
|---|---|---|
| Emergency Department Use | 9 | 9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Integrative Medical Group Visits | 0/76 (0%) | 1/76 (1.3%) | 19/76 (25%) |
| Standard of Care | 0/79 (0%) | 1/79 (1.3%) | 13/79 (16.5%) |
| All Participants | 0/155 (0%) | 2/155 (1.3%) | 32/155 (20.6%) |
| Event | Integrative Medical Group Visits | Standard of Care | All Participants |
|---|---|---|---|
| Hospitalization unrelated to studyGeneral disorders | 1/76 | 1/79 | 2/155 |
| Event | Integrative Medical Group Visits | Standard of Care | All Participants |
|---|---|---|---|
| Non Serious Adverse EventsGeneral disorders | 19/76 | 13/79 | 32/155 |
\*We did not include intervention data on the four participants who withdrew consent.
| Age, Continuous(years) | Integrative Medical Group Visits | Standard of Care | Total |
|---|---|---|---|
| Mean | 50 ± 12.2 | 51 ± 12.4 | 50.5 ± 12.3 |
| Sex: Female, Male(Participants) | Integrative Medical Group Visits | Standard of Care | Total |
|---|---|---|---|
| Female | 64 | 70 | 134 |
| Male | 12 | 9 | 21 |
| Ethnicity (NIH/OMB)(Participants) | Integrative Medical Group Visits | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 12 | 22 |
| Not Hispanic or Latino | 66 | 67 | 133 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Integrative Medical Group Visits | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 44 | 43 | 87 |
| White | 12 | 17 | 29 |
| More than one race | 5 | 4 | 9 |
| Unknown or Not Reported | 15 | 15 | 30 |
| Study Sites(Participants) | Integrative Medical Group Visits | Standard of Care | Total |
|---|---|---|---|
| Boston Medical Center | 33 | 35 | 68 |
| Dotwell Health Center | 19 | 21 | 40 |
| Codman Square Health Center | 24 | 23 | 47 |
| Income(Participants) | Integrative Medical Group Visits | Standard of Care | Total |
|---|---|---|---|
| Less than $5K | 9 | 11 | 20 |
| $5K-$29.99K | 36 | 41 | 77 |
| $30K and over | 6 | 7 | 13 |
| Refused/ DK/ No income | 25 | 20 | 45 |
| Work Status(Participants) | Integrative Medical Group Visits | Standard of Care | Total |
|---|---|---|---|
| Full/ Part time | 15 | 17 | 32 |
| Unemployed | 10 | 12 | 22 |
| Retired/ Homemaker | 9 | 9 | 18 |
| Sick Leave/ Disability | 32 | 34 | 66 |
| Other | 10 | 7 | 17 |
| Education Level(Participants) | Integrative Medical Group Visits | Standard of Care | Total |
|---|---|---|---|
| < High school/ some HS | 15 | 12 | 27 |
| High school degree | 22 | 31 | 53 |
| Some college/ AA degree | 30 | 23 | 53 |
| College degree or higher | 9 | 13 | 22 |
2 further baseline measures are reported on the registry.
Plan to share: No
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