Enric Aragonès1, Concepció Rambla2, Germán López-Cortacans2, Catarina Tomé-Pires3, Elisabet Sánchez-Rodríguez4, Antonia Caballero2, Jordi Miró4. 1. Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Atenció Primària Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain. Electronic address: earagones.tgn.ics@gencat.cat. 2. Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Atenció Primària Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain. 3. Atenció Primària Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain; Unit for the Study and Treatment of Pain - ALGOS, and Research Center for Behavior Assessment (CRAMC), Department of Psychology, Universitat Rovira i Virgili, Tarragona, Spain; Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira i Virgili, Tarragona, Spain. 4. Unit for the Study and Treatment of Pain - ALGOS, and Research Center for Behavior Assessment (CRAMC), Department of Psychology, Universitat Rovira i Virgili, Tarragona, Spain; Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira i Virgili, Tarragona, Spain.
Abstract
BACKGROUND: Depression and chronic musculoskeletal pain commonly occur as comorbid conditions, which increases their negative effects on health outcomes. The objective of this study was to assess the effectiveness of the DROP (DepRessiOn and Pain) programme designed for the management of major depression and chronic musculoskeletal pain in primary care. METHODS: A cluster-randomised controlled trial was carried out between June 2015 and December 2017 with 328 patients with major depression and chronic musculoskeletal pain, randomly allocated to either intervention arm or usual care arm. The intervention included care management, optimised management of depression, and a psychoeducational programme. Outcomes were monitored using blinded interviews over a 12-month period. TRIAL REGISTRATION: NCT02605278 (ClinicalTrials.gov). RESULTS: After 12 months, 274 patients were evaluated (83.5% participation). The severity of depression (Hopkins Symptom Checklist score) was 0.23 points lower in the intervention arm [1.11 vs. 1.34; CI95% = -0.42 to -0.04]. Intervention arm's response rate to antidepressant treatment was 18.9% higher [39.6% vs. 20.7%; OR = 2.74; CI95% = 1.12-6.67] and its remission rate for depression was 9.0% higher [20.1% vs. 11.1%; OR = 2.13; CI95% = 0.94-4.85] compared to the usual care arm. There were no significant differences between the two arms in terms of pain severity (Brief Pain Inventory severity score) [6.23 vs. 6.66; difference = -0.39; CI95% = -1.13-0.35] or pain response rate [18.7% vs. 18.5%; OR = 1.02; CI95% = 0.46-2.26]. LIMITATIONS: This is a pragmatic study, and poor adherence to the programme by patients and physicians was a main limitation. CONCLUSION: The programme improves clinical outcomes for depression, although no clinical benefits were seen for pain.
RCT Entities:
BACKGROUND:Depression and chronic musculoskeletal pain commonly occur as comorbid conditions, which increases their negative effects on health outcomes. The objective of this study was to assess the effectiveness of the DROP (DepRessiOn and Pain) programme designed for the management of major depression and chronic musculoskeletal pain in primary care. METHODS: A cluster-randomised controlled trial was carried out between June 2015 and December 2017 with 328 patients with major depression and chronic musculoskeletal pain, randomly allocated to either intervention arm or usual care arm. The intervention included care management, optimised management of depression, and a psychoeducational programme. Outcomes were monitored using blinded interviews over a 12-month period. TRIAL REGISTRATION: NCT02605278 (ClinicalTrials.gov). RESULTS: After 12 months, 274 patients were evaluated (83.5% participation). The severity of depression (Hopkins Symptom Checklist score) was 0.23 points lower in the intervention arm [1.11 vs. 1.34; CI95% = -0.42 to -0.04]. Intervention arm's response rate to antidepressant treatment was 18.9% higher [39.6% vs. 20.7%; OR = 2.74; CI95% = 1.12-6.67] and its remission rate for depression was 9.0% higher [20.1% vs. 11.1%; OR = 2.13; CI95% = 0.94-4.85] compared to the usual care arm. There were no significant differences between the two arms in terms of pain severity (Brief Pain Inventory severity score) [6.23 vs. 6.66; difference = -0.39; CI95% = -1.13-0.35] or pain response rate [18.7% vs. 18.5%; OR = 1.02; CI95% = 0.46-2.26]. LIMITATIONS: This is a pragmatic study, and poor adherence to the programme by patients and physicians was a main limitation. CONCLUSION: The programme improves clinical outcomes for depression, although no clinical benefits were seen for pain.
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