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.

Abstract

Background: Given the public health crisis of opioid overprescribing for pain, there is a need for evidence-based non pharmacological treatment options that effectively reduce pain and depression. We aim to examine the effectiveness of the Integrative Medical Group Visits (IMGV) model in reducing chronic pain and depressive symptoms, as well as increasing pain self-management.

Methods: This paper details the study design and implementation of an ongoing randomized controlled trial of the IMGV model as compared to primary care visits. The research aims to determine if the IMGV model is effective in achieving: a) a reduction in self-reported pain and depressive symptoms and 2) an improvement in the self-management of pain, through increasing pain self-efficacy and reducing use of self-reported pain medication. We intend to recruit 154 participants to be randomized in our intervention, the IMGV model (n=77) and to usual care (n=77).

Conclusions: Usual care of chronic pain through pharmacological treatment has mixed evidence of efficacy and may not improve quality of life or functional status. We aim to conduct a randomized controlled trial to evaluate the effectiveness of the IMGV model as compared to usual care in reducing self-reported pain and depressive symptoms as well as increasing pain management skills.

Trial registration: ClinicalTrials.gov NCT02262377.

Keywords: Integrative medicine; Medical group visits; Mindfulness; Mindfulness based stress reduction; Shared medical appointments; eHealth.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Analgesics / therapeutic use
  • Chronic Pain / complications
  • Chronic Pain / psychology
  • Chronic Pain / therapy*
  • Comparative Effectiveness Research
  • Delivery of Health Care / methods*
  • Depressive Disorder / complications
  • Depressive Disorder / psychology
  • Depressive Disorder / therapy*
  • Evidence-Based Medicine
  • Group Processes
  • Health Education
  • Health Services Accessibility
  • Humans
  • Integrative Medicine
  • Mindfulness
  • Primary Health Care / methods*
  • Self Efficacy
  • Self-Management
  • Social Support
  • Vulnerable Populations*

Substances

  • Analgesics

Associated data

  • ClinicalTrials.gov/NCT02262377