Chronic PainIMGVNCT02262377
Integrative Medicine Group Visits: A Patient-Centered Approach to Reducing Chronic Pain and Depression
A study testing Integrative Medicine Group Visits in people with Chronic Pain and Depression, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Depression
- What is being tested?
- Integrative Medicine Group Visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain, Depression
- Being tested
- Integrative Medicine Group Visits
- Keywords
- Group Medical Visits, Integrative Medicine, Chronic Pain, Depression, MBSR, Mindfulness Based Stress Reduction, Web based, Virtual Patient Advocate, Internet Based
- Medical subject headings
- Chronic Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative Medicine Group VisitsBehavioural
Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum.
| Study group | Role | What they receive |
|---|---|---|
| Integrative Medicine Group Visits | Experimental | 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 Receives: Behavioral: Integrative Medicine Group Visits |
| Standard of Care | No intervention | primary care visits, which include medications and advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: This was conducted at 21 weeks.
Secondary outcomes (1)
Emergency Department Use
Number of emergency room visits based on chart review data collection.
Measured: This was collected at 21 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startApr 2015
- Primary completionSep 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula Gardiner, MD, MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262377
- Sponsor's protocol ID
- H-33096
- Acronym
- IMGV
- Status last verified
- Aug 2019
- First submitted
- 28 Sep 2014
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Upshur CC, Luckmann RS, Savageau JA. Primary care provider concerns about management of chronic pain in community clinic populations. J Gen Intern Med. 2006 Jun;21(6):652-5. doi: 10.1111/j.1525-1497.2006.00412.x.
PubMed 16808752Niazi AK, Niazi SK. Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. N Am J Med Sci. 2011 Jan;3(1):20-3. doi: 10.4297/najms.2011.320.
PubMed 22540058Cramer H, Lauche R, Paul A, Dobos G. Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis. Curr Oncol. 2012 Oct;19(5):e343-52. doi: 10.3747/co.19.1016.
PubMed 23144582Cramer H, Haller H, Lauche R, Dobos G. Mindfulness-based stress reduction for low back pain. A systematic review. BMC Complement Altern Med. 2012 Sep 25;12:162. doi: 10.1186/1472-6882-12-162.
PubMed 23009599Fjorback LO, Arendt M, Ornbol E, Fink P, Walach H. Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Acta Psychiatr Scand. 2011 Aug;124(2):102-19. doi: 10.1111/j.1600-0447.2011.01704.x. Epub 2011 Apr 28.
PubMed 21534932Carnes D, Homer KE, Miles CL, Pincus T, Underwood M, Rahman A, Taylor SJ. Effective delivery styles and content for self-management interventions for chronic musculoskeletal pain: a systematic literature review. Clin J Pain. 2012 May;28(4):344-54. doi: 10.1097/AJP.0b013e31822ed2f3.
PubMed 22001667Eisenstat SA, Ulman K, Siegel AL, Carlson K. Diabetes group visits: integrated medical care and behavioral support to improve diabetes care and outcomes from a primary care perspective. Curr Diab Rep. 2013 Apr;13(2):177-87. doi: 10.1007/s11892-012-0349-5.
PubMed 23207990Gardiner P, Dresner D, Barnett KG, Sadikova E, Saper R. Medical group visits: a feasibility study to manage patients with chronic pain in an underserved urban clinic. Glob Adv Health Med. 2014 Jul;3(4):20-6. doi: 10.7453/gahmj.2014.011.
PubMed 25105072Nephew BC, Incollingo Rodriguez AC, Melican V, Polcari JJ, Nippert KE, Rashkovskii M, Linnell LB, Hu R, Ruiz C, King JA, Gardiner P. Depression Predicts Chronic Pain Interference in Racially Diverse, Income-Disadvantaged Patients. Pain Med. 2022 Jul 1;23(7):1239-1248. doi: 10.1093/pm/pnab342.
PubMed 34908146Gardiner P, Luo M, D'Amico S, Gergen-Barnett K, White LF, Saper R, Mitchell S, Liebschutz JM. Effectiveness of integrative medicine group visits in chronic pain and depressive symptoms: A randomized controlled trial. PLoS One. 2019 Dec 18;14(12):e0225540. doi: 10.1371/journal.pone.0225540. eCollection 2019.
PubMed 31851666Gardiner P, Lestoquoy AS, Gergen-Barnett K, Penti B, White LF, Saper R, Fredman L, Stillman S, Lily Negash N, Adelstein P, Brackup I, Farrell-Riley C, Kabbara K, Laird L, Mitchell S, Bickmore T, Shamekhi A, Liebschutz JM. Design of the integrative medical group visits randomized control trial for underserved patients with chronic pain and depression. Contemp Clin Trials. 2017 Mar;54:25-35. doi: 10.1016/j.cct.2016.12.013. Epub 2016 Dec 13.
PubMed 27979754
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Medicine Group Visits: A Patient-Centered Approach to Reducing Chronic Pain and Depression in a Disparate Urban Population
- ClinicalTrials.gov ID
- NCT02262377
- Acronym / sponsor ID
- IMGV / H-33096
- Conditions
- Chronic Pain, Depression
- Keywords
- Group Medical Visits, Integrative Medicine, Chronic Pain, Depression, MBSR, Mindfulness Based Stress Reduction, Web based, Virtual Patient Advocate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrative Medicine Group Visits | Experimental | Behavioral: Integrative Medicine Group Visits9-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 |
| Standard of Care | No intervention | –primary care visits, which include medications and advice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative Medicine Group VisitsPatients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum. | Behavioural | Integrative Medicine Group Visits |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Emergency Department Use
Time frame: This was collected at 21 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16808752Upshur CC, Luckmann RS, Savageau JA. Primary care provider concerns about management of chronic pain in community clinic populations. J Gen Intern Med. 2006 Jun;21(6):652-5. doi: 10.1111/j.1525-1497.2006.00412.x.
- Background: PubMed 22540058Niazi AK, Niazi SK. Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. N Am J Med Sci. 2011 Jan;3(1):20-3. doi: 10.4297/najms.2011.320.
- Background: PubMed 23144582Cramer H, Lauche R, Paul A, Dobos G. Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis. Curr Oncol. 2012 Oct;19(5):e343-52. doi: 10.3747/co.19.1016.
- Background: PubMed 23009599Cramer H, Haller H, Lauche R, Dobos G. Mindfulness-based stress reduction for low back pain. A systematic review. BMC Complement Altern Med. 2012 Sep 25;12:162. doi: 10.1186/1472-6882-12-162.
- Background: PubMed 21534932Fjorback LO, Arendt M, Ornbol E, Fink P, Walach H. Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Acta Psychiatr Scand. 2011 Aug;124(2):102-19. doi: 10.1111/j.1600-0447.2011.01704.x. Epub 2011 Apr 28.
- Background: PubMed 22001667Carnes D, Homer KE, Miles CL, Pincus T, Underwood M, Rahman A, Taylor SJ. Effective delivery styles and content for self-management interventions for chronic musculoskeletal pain: a systematic literature review. Clin J Pain. 2012 May;28(4):344-54. doi: 10.1097/AJP.0b013e31822ed2f3.
- Background: PubMed 23207990Eisenstat SA, Ulman K, Siegel AL, Carlson K. Diabetes group visits: integrated medical care and behavioral support to improve diabetes care and outcomes from a primary care perspective. Curr Diab Rep. 2013 Apr;13(2):177-87. doi: 10.1007/s11892-012-0349-5.
- Results publication: PubMed 25105072Gardiner P, Dresner D, Barnett KG, Sadikova E, Saper R. Medical group visits: a feasibility study to manage patients with chronic pain in an underserved urban clinic. Glob Adv Health Med. 2014 Jul;3(4):20-6. doi: 10.7453/gahmj.2014.011.
- Derived from this study: PubMed 34908146Nephew BC, Incollingo Rodriguez AC, Melican V, Polcari JJ, Nippert KE, Rashkovskii M, Linnell LB, Hu R, Ruiz C, King JA, Gardiner P. Depression Predicts Chronic Pain Interference in Racially Diverse, Income-Disadvantaged Patients. Pain Med. 2022 Jul 1;23(7):1239-1248. doi: 10.1093/pm/pnab342.
- Derived from this study: PubMed 31851666Gardiner P, Luo M, D'Amico S, Gergen-Barnett K, White LF, Saper R, Mitchell S, Liebschutz JM. Effectiveness of integrative medicine group visits in chronic pain and depressive symptoms: A randomized controlled trial. PLoS One. 2019 Dec 18;14(12):e0225540. doi: 10.1371/journal.pone.0225540. eCollection 2019.
- Derived from this study: PubMed 27979754Gardiner P, Lestoquoy AS, Gergen-Barnett K, Penti B, White LF, Saper R, Fredman L, Stillman S, Lily Negash N, Adelstein P, Brackup I, Farrell-Riley C, Kabbara K, Laird L, Mitchell S, Bickmore T, Shamekhi A, Liebschutz JM. Design of the integrative medical group visits randomized control trial for underserved patients with chronic pain and depression. Contemp Clin Trials. 2017 Mar;54:25-35. doi: 10.1016/j.cct.2016.12.013. Epub 2016 Dec 13.
- Description From the Patient-Centered Outcomes Research Institute websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Gardiner, MD, MPH principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative Medicine Group Visits in people with Chronic Pain and Depression, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Pain (time frame: This was conducted at 21 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02262377, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.