Integrative Medicine Group Visits: A Patient-Centered Approach to Reducing Chronic Pain and Depression (IMGV)

August 11, 2019 updated by: Boston Medical Center

Integrative Medicine Group Visits: A Patient-Centered Approach to Reducing Chronic Pain and Depression in a Disparate Urban Population

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Integrative Medicine Group Visits
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
Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum.
No Intervention: Standard of Care
primary care visits, which include medications and advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic Pain
Time Frame: This was conducted at 21 weeks.
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.
This was conducted at 21 weeks.
Depression
Time Frame: This was conducted at 21 weeks.
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.
This was conducted at 21 weeks.
Pain Self Efficacy Scale
Time Frame: This was conducted at 21 weeks.
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.
This was conducted at 21 weeks.
Pain Medication Use
Time Frame: This was conducted at 21 weeks.
Number of participants reported pain medication in the past seven day. This was obtained at 21 weeks.
This was conducted at 21 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergency Department Use
Time Frame: This was collected at 21 weeks.
Number of emergency room visits based on chart review data collection.
This was collected at 21 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

September 28, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 11, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-33096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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