Clinical trial NCT02262377: Integrative Medicine Group Visits: A Patient-Centered Approach to Reducing Chronic Pain and Depression
Official title: Integrative Medicine Group Visits: A Patient-Centered Approach to Reducing Chronic Pain and Depression in a Disparate Urban Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Depression
Keywords: Group Medical Visits
Integrative Medicine
Chronic Pain
Depression
MBSR
Mindfulness Based Stress Reduction
Web based
Virtual Patient Advocate
Internet Based
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Integrative Medicine Group Visits (IMGV) are effective for treating patients with chronic pain and depression.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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 questions.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Chronic Pain
timeFrame: This was conducted at 21 weeks.
measure: Depression
timeFrame: This was conducted at 21 weeks.
measure: Pain Self Efficacy Scale
timeFrame: This was conducted at 21 weeks.
measure: Pain Medication Use
timeFrame: This was conducted at 21 weeks.
Secondary outcomes:
measure: Emergency Department Use
timeFrame: This was collected at 21 weeks.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Paula Gardiner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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