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

NCT02262377 | Completed Results DMC

• 1 other identifier: H-33096
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  This was conducted at 21 weeks.

Secondary Outcomes (1)

• Emergency Department Use

  This was collected at 21 weeks.

Study Arms (2)

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

Behavioral: Integrative Medicine Group Visits

Standard of Care

NO INTERVENTION

primary care visits, which include medications and advice

Interventions

Integrative Medicine Group Visits BEHAVIORAL

Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum.

Integrative Medicine Group Visits

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (11)

• 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.

  PMID: 16808752 BACKGROUND

• Niazi 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.

  PMID: 22540058 BACKGROUND

• Cramer 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.

  PMID: 23144582 BACKGROUND

• Cramer 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.

  PMID: 23009599 BACKGROUND

• Fjorback 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.

  PMID: 21534932 BACKGROUND

• Carnes 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.

  PMID: 22001667 BACKGROUND

• Eisenstat 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.

  PMID: 23207990 BACKGROUND

• Gardiner 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.

  PMID: 25105072 RESULT

• Nephew 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.

  PMID: 34908146 DERIVED

• Gardiner 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.

  PMID: 31851666 DERIVED

• Gardiner 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.

  PMID: 27979754 DERIVED

Related Links

• Description From the Patient-Centered Outcomes Research Institute website

MeSH Terms

Conditions

Chronic Pain; Depression

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Limitations and Caveats

Our limitations for this study includes: study participation (intervention group did not all attend IMGV and not everyone in control group attended PCP visit), no data on baseline antidepressants medication, only English speaking patients included.

Results Point of Contact

• Title: Paula Gardiner
• Organization: Boston Medical Center

Paula.GardinerMD@gmail.com

414-6267

Study Officials

• Paula Gardiner, MD, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2014
• First Posted: October 13, 2014
• Study Start: April 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)