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Effectiveness of integrative medicine group visits in chronic pain and depressive symptoms: A randomized controlled trial.

ABSTRACT: BACKGROUND:Current treatment options for chronic pain and depression are largely medication-based, which may cause adverse side effects. Integrative Medical Group Visits (IMGV) combines mindfulness techniques, evidence based integrative medicine, and medical group visits, and is a promising adjunct to medications, especially for diverse underserved patients who have limited access to non-pharmacological therapies. OBJECTIVE:Determine the effectiveness of IMGV compared to a Primary Care Provider (PCP) visit in patients with chronic pain and depression. DESIGN:9-week single-blind randomized control trial with a 12-week maintenance phase (intervention-medical groups; control-primary care provider visit). SETTING:Academic tertiary safety-net hospital and 2 affiliated federally-qualified community health centers. PARTICIPANTS:159 predominantly low income racially diverse adults with nonspecific chronic pain and depressive symptoms. INTERVENTIONS:IMGV intervention- 9 weekly 2.5 hour in person IMGV sessions, 12 weeks on-line platform access followed by a final IMGV at 21 weeks. MEASUREMENTS:Data collected at baseline, 9, and 21 weeks included primary outcomes depressive symptoms (Patient Health Questionnaire 9), pain (Brief Pain Inventory). Secondary outcomes included pain medication use and utilization. RESULTS:There were no differences in pain or depression at any time point. At 9 weeks, the IMGV group had fewer emergency department visits (RR 0.32, 95% CI: 0.12, 0.83) compared to controls. At 21 weeks, the IMGV group reported reduction in pain medication use (Odds Ratio: 0.42, CI: 0.18-0.98) compared to controls. LIMITATIONS:Absence of treatment assignment concealment for patients and disproportionate group attendance in IMGV. CONCLUSION:Results demonstrate that low-income racially diverse patients will attend medical group visits that focus on non-pharmacological techniques, however, in the attention to treat analysis there was no difference in average pain levels between the intervention and the control group. TRIAL REGISTRATION:clinicaltrials.gov NCT02262377.

SUBMITTER: Gardiner P

PROVIDER: S-EPMC6919581 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Effectiveness of integrative medicine group visits in chronic pain and depressive symptoms: A randomized controlled trial.

Gardiner Paula P Luo Man M D'Amico Salvatore S Gergen-Barnett Katherine K White Laura F LF Saper Robert R Mitchell Suzanne S Liebschutz Jane M JM

PloS one 20191218 12

<h4>Background</h4>Current treatment options for chronic pain and depression are largely medication-based, which may cause adverse side effects. Integrative Medical Group Visits (IMGV) combines mindfulness techniques, evidence based integrative medicine, and medical group visits, and is a promising adjunct to medications, especially for diverse underserved patients who have limited access to non-pharmacological therapies.<h4>Objective</h4>Determine the effectiveness of IMGV compared to a Primary ...[more]

PMID: 31851666

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Project description:OBJECTIVES:Chronic low-back pain (CLBP) is burdensome and costly, and a common condition for which adults use integrative therapies. The effectiveness of multidisciplinary integrative approaches has not been well studied. The purpose of this observational study was to compare characteristics and outcomes of CLBP patients treated at the Osher Clinical Center (OCC) versus other clinics at Brigham and Women's Hospital. DESIGN:Observational comparative effectiveness study. SETTING:Tertiary care hospital. SUBJECTS:Patients ?21 years with 3+ months of CLBP or 6+ months of intermittent low-back pain. INTERVENTION:All patients were observed for 12 months. OCC patients received care at the integrative clinic (7.3 visits on average over 13 weeks); non-OCC patients received usual care at other clinics of the same hospital. OUTCOME MEASURES:Primary outcomes: change from baseline to 6 months in functional status (Roland Disability Questionnaire [RDQ]) and bothersomeness of pain (BOP). SECONDARY OUTCOMES:change in RDQ and BOP at 3 and 12 months, percentages of patients with clinically meaningful (?30%) improvements. RESULTS:One hundred fifty-six OCC and 153 non-OCC participants were enrolled; follow-up was 90.4 and 98.0%, respectively, at 12 months. There were substantial differences in baseline characteristics between groups. For RDQ, the adjusted mean group difference was nonsignificant at 6 months; for BOP, the differences were significant, but clinically small. At 12 months, the observed benefit on RDQ was significant and clinically meaningful; for BOP, there were significant, but clinically small differences. Percentages of patients with ?30% improvements in RDQ were significantly greater in the OCC group only at 12 months, and both 6 and 12 months for BOP. CONCLUSIONS:Baseline characteristics can differ between those who select different sources of healthcare for CLBP. While benefits seen in the OCC versus non-OCC clinics were not large, further evaluation through randomized trials might be warranted to provide a more definitive evaluation.

Project description:BackgroundChronic pain and depression are common comorbid conditions, but there is limited evidence-based guidance for management of the two conditions together. In recent years, there has been an increase in the number of chronic pain randomized controlled trials that collect depression outcomes, but it is unknown how often these trials include people with depression or significant depressive symptoms. If trials do not include participants representative of real-world populations, evidence and guidance generated from these trials risk being inapplicable for large proportions of the target population, or worse, risk harm. Thus, in order to identify pathways to improve the conduct of clinical trials, the aims of this study were to (1) estimate the proportion of randomized controlled trials evaluating chronic pain interventions and reporting depression outcomes that include participants with significant depressive symptoms; and (2) assess the variability of inclusion proportions by pain type, intervention type, gender, country of origin, and publication year.MethodsStudies were extracted from an umbrella review of interventions for chronic pain that reported depression outcomes. Screening and data extraction were completed in duplicate and conflicts were resolved by a third author. Randomized controlled trials with at least 50% adult participants and validated depression scales were included, and randomized controlled trials with populations whose mean scores were at or above depression thresholds at baseline were considered to have included participants with depression.ResultsOf the 346 randomized controlled trials analyzed, 142 (41%) included participants with depression. Eight pain-type groups and nine intervention types were identified. Randomized controlled trials investigating fibromyalgia and mixed chronic pain had the highest proportion of participants with depression, whereas studies of arthritis and axial pain had among the lowest. Randomized controlled trials from the United States had a significantly lower inclusion proportion compared with non-US studies, especially for studies on arthritis. The increase in inclusion proportion by publication year was driven by the increase in fibromyalgia studies.Discussion and conclusionThis study highlights opportunities to improve the conduct of chronic pain clinical trials. The majority of randomized controlled trials s analyzed evaluated participants without significant depressive symptoms at baseline, thus the findings synthesized in systematic reviews and subsequent guidelines are most applicable to the subset of real-world populations that do not have significant depressive symptoms. As well, systemic biases around psychological conditions and gender may be important contributors to differences in the study of depression in fibromyalgia compared with common conditions such as arthritis and axial pain. In order to better inform clinical practice, future research must intentionally include individuals with comorbid depression in trials of common chronic pain conditions, and consider methods to mitigate biases that may distort study design.

Project description:ObjectivesTo report the results of health economic analyses comparing two treatment approaches for chronic low back pain (CLBP).DesignObservational prospective cohort study comparing effectiveness and cost-effectiveness of CLBP care provided at an integrative care clinic with that provided in other clinics within the same hospital. CLBP-related medical utilization, function, quality of life, and days of work incapacity were self-reported at baseline, 3, 6, and 12 months.Settings/locationOsher Clinical Center (OCC) based at a tertiary academic hospital (Brigham and Women's Hospital [BWH]) and other clinics at BWH.SubjectsCLBP patients seeking care at OCC or non-OCC BWH clinics.InterventionsIntegrative or conventional care for CLBP as prescribed by the treating clinician(s).Outcome measuresQuality-adjusted life years (QALYs) were estimated per treatment approach based on the SF-12. Cost per QALY gained was evaluated using an incremental cost-effectiveness ratio (ICER). ICERs based on CLBP-specific effectiveness measures (Roland Disability Questionnaire [RDQ] and bothersomeness of pain [BOP]) were exploratory outcomes.ResultsTotal adjusted annual CLBP-related costs per patient were greater in the OCC versus non-OCC group ($11,526.73 vs. $6,810.63). Between group differences in QALYs were small and ICER estimate of cost per QALY gained was high ($436,676). However, unadjusted mean direct costs per patient decreased over time in the OCC group. Savings in direct costs of $391 (95% confidence interval: -1,078 to 1,861) were observed in the OCC group for the 6- to 12-month period, driven primarily by reduced medication usage. ICERs based on adjusted RDQ and BOP group differences showed cost of $2,073 and $4,203 for a one-point reduction per respective scale.ConclusionsWhen adjusted for baseline differences, self-reported costs were higher in the OCC group with only small effects on QALYs. However, trends toward decreased direct expenditures and medication usage over time warrant further investigation. Future studies evaluating potential benefits of integrative care models for the management of CLBP should employ randomized designs, longer observational periods, and explore multiple metrics of cost-effectiveness.

Dataset Information

Effectiveness of integrative medicine group visits in chronic pain and depressive symptoms: A randomized controlled trial.

Publications

Effectiveness of integrative medicine group visits in chronic pain and depressive symptoms: A randomized controlled trial.

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