Dataset Information

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

ACCESS DATA

Publications

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:BackgroundApproximately 20% of adults in the United States experience chronic pain. Integrative Medical Group Visit (IMGV) offers an innovative approach to chronic pain management through training in mindfulness, nutrition, and other mind-body techniques combined with peer support. To date, there are no studies on IMGV implementation, despite its promise as a feasible non-pharmacological intervention for chronic pain management. In this study, we assessed the feasibility of implementing IMGV and assessing its effectiveness for chronic pain.MethodsImplementation Mapping was used to develop and evaluate implementation strategies for IMGV. Strategies included disseminating educational materials, conducting ongoing training, and conducting educational meetings. IMGV was delivered by three healthcare providers: an allopathic physician, registered yoga teacher, and naturopathic physician. The effectiveness of IMGV on patient health outcomes was assessed through qualitative interviews and a Patient-Reported Outcomes Scale (PROMIS-29). Provider perspectives of acceptability, appropriateness, and feasibility were assessed through periodic reflections (group interviews reflecting on the process of implementation) and field notes. Paired t-tests were used to assess changes between scores at baseline and post intervention. Qualitative data were coded by three experienced qualitative researchers using thematic content analysis.ResultsOf the initial 16 patients enrolled in research, 12 completed at least two sessions of the IMGV. Other than fatigue, there was no statistically significant difference between the pre- and post-scores. Patients reported high satisfaction with IMGV, noting the development of new skills for self-care and the supportive community of peers. Themes from patient interviews and periodic reflections included the feasibility of virtual delivery, patient perspectives on acceptability, provider perspectives of feasibility and acceptability, ease of recruitment, complexity of referral and scheduling process, balancing medical check-in with group engagement, and nursing staff availability.ConclusionsIMGV was feasible, acceptable, and effective from the perspectives of patients and providers. Although statistically significant differences were not observed for most PROMIS measures, qualitative results suggested that participants experienced increased social support and increased pain coping skills. Providers found implementation strategies effective, except for engaging nurses, due to staff being overwhelmed from the pandemic. Lessons learned from this pilot study can inform future research on implementation of IMGV.

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:ObjectiveTo investigate the effects of an intervention for pain competence and depression prevention for multidisciplinary inpatient rehabilitation of non-specific chronic low back pain on psychological and work-related outcomes over a 2-year period.MethodsThis prospective randomized controlled multicenter trial evaluated the effects of pain competence training with and without depression prevention on depressive symptoms (General Depression Scale; ADS; primary outcome), anxiety (Hospital Anxiety and Depression Scale), pain self-efficacy (Pain Self-Efficacy Questionnaire) and subjective prognosis of gainful employment (SPE; secondary outcomes) in n=422 patients aged 32-64 years from four rehabilitation clinics. Per protocol analyses were conducted. In the three-factorial design with a repeated-measures factor, patients were stratified by treatment condition; the control group (CG) received only pain management training but the intervention group (IG) was additionally treated with depression prevention training (Debora). Based on the ADS, patients were assigned to without or low depressive symptoms (ADS<23; n=208) and medium or high depressive symptoms (ADS≥23; n=214). The fivefold repeated-measures factor included the following sample points: admission, immediately after and 6, 12, and 24 months after rehabilitation. Per protocol results of univariate 2×2×5 analyses of variance were validated by n=1225 multiple imputed data.ResultsNo significant effects of treatment condition over the 2-year period were yielded in the primary outcome "depressive symptoms", but only patients with the combined training Debora benefited in pain self-efficacy in the long term. Intention-to-treat analyses suggest incremental effects of Debora on pain self-efficacy and anxiety at 24-month follow-up. In the long term, patients with high levels of depressive symptoms improved exclusively in depressive symptoms or they benefited more than patients with low depression in anxiety. However, favorable effects receded in general from post rehabilitation to 24-month follow-up.Discussion The results support that a disorder-specific depression prevention training is needed for the long-term improvement in pain self-efficacy, which is considered a crucial psychological protective factor in pain chronification. Findings on depressive symptoms support the effectiveness of multidisciplinary inpatient rehabilitation in high depression, but also the great importance of early treatment of depressive symptoms.Conclusion Overall, the results strengthen the need to implement psychotherapeutic treatment elements and, in particular, cognitive-behavioral methods and, moreover, a systematic allocation of patients to needs-based treatments in order to improve long-term effects.

Project description:Objectives: Implementation science is key to translating complementary and integrative health intervention research into practice as it can increase accessibility and affordability while maximizing patient health outcomes. The authors describe using implementation mapping to (1) identify barriers and facilitators impacting the implementation of an Integrative Medical Group Visit (IMGV) intervention in an outpatient setting with a high burden of patients with chronic pain and (2) select and develop implementation strategies utilizing theory and stakeholder input to address those barriers and facilitators. Design: The authors selected a packaged, evidence-based, integrative pain management intervention, the IMGV, to implement in an outpatient clinic with a high burden of patients with chronic pain. The authors used implementation mapping to identify implementation strategies for IMGV, considering theory and stakeholder input. Stakeholder interviews with clinic staff, faculty, and administrators (n = 15) were guided by the Consolidated Framework for Implementation Research. Results: Based on interview data, the authors identified administrators, physicians, nursing staff, and scheduling staff as key stakeholders involved in implementation. Barriers and facilitators focused on knowledge, buy-in, and operational procedures needed to successfully implement IMGV. The implementation team identified three cognitive influences on behavior that would impact performance: knowledge, outcome expectations, and self-efficacy; and three theoretical change methods: cue to participate, communication, and mobilization. Implementation strategies identified included identifying and preparing champions, participation in ongoing training, developing and distributing educational materials, and organizing clinician implementation team meetings. Conclusions: This study provides an example of the application of implementation mapping to identify theory-driven implementation strategies for IMGV. Implementation mapping is a feasible method that may be useful in providing a guiding structure for implementation teams as they employ implementation frameworks and select implementation strategies for integrative health interventions.

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.

Background

Objective

Design

Setting

Participants

Interventions

Measurements

Results

Limitations

Conclusion

Trial registration

Publications

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

Similar Datasets

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