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.
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.
- self-reported chronic pain for at least 12 weeks
- average pain intensity for the previous week >4 on a 0 to 10 numerical rating scale;
PHQ-9 score >5, indicating minor depression or greater
- English fluency sufficient to follow treatment instructions and answer survey
- previous participation in IMGV
- new pain treatments in past month or anticipated to begin in next 3 months
- active or planned worker's compensation, disability, or personal injury claims
- known or planned pregnancy
- manic symptoms
- active suicidality
- psychotic symptoms
- no PCP