title: Evaluation of a multicomponent programme for the management of musculoskeletal pain and depression in primary care: a cluster-randomised clinical trial (the DROP study).
abstract: Chronic musculoskeletal pain and depression are very common in primary care patients. Furthermore, they often appear as comorbid conditions, resulting in additive effect on adverse health outcomes. On the basis of previous studies, we hypothesise that depression and chronic musculoskeletal pain may benefit from an integrated management programme at primary care level. We expect positive effects on both physical and psychological distress of patients.
  
  
  
  
  
  
  
  To determine whether a new programme for an integrated approach to chronic musculoskeletal pain and depression leads to better outcomes than usual care.
  
  
  
  Cluster-randomised controlled trial involving two arms: a) control arm (usual care); and b) intervention arm, where patients participate in a programme for an integrated approach to the pain-depression dyad.
  
  
  
  Primary care centres in the province of Tarragona, Catalonia, Spain, Participants: We will recruit 330 patients aged 18-80 with moderate or severe musculoskeletal pain (Brief Pain Inventory, average pain subscale ≥5) for at least 3 months, and with criteria for major depression (DSM-IV).
  
  
  
  A multicomponent programme according to the chronic care model. The main components are care management, optimised antidepressant treatment, and a psychoeducational group action. Blind measurements: The patients will be monitored through blind telephone interviews held at 0, 3, 6 and 12 months.
  
  
  
  Severity of pain and depressive symptoms, pain and depression treatment response rates, and depression remission rates.
  
  
  
  The outcomes will be analysed on an intent-to-treat basis and the analysis units will be the individual patients. This analysis will consider the effect of the study design on any potential lack of independence between observations made within the same cluster.
  
  
  
  The protocol was approved by the Research Ethics Committee of the Jordi Gol Primary Care Research Institute (IDIAP), Barcelona, (P14/142).
  
  
  
  This project strengthens and improves treatment approaches for a major comorbidity in primary care. The design of the intervention takes into account its applicability under typical primary care conditions, so that if the programme is found to be effective it will be feasible to apply it in a generalised manner.
  
  
  
  ClinicalTrials.gov: NCT02605278 ; Registered 28 September, 2015.
authors.affiliation: Atenció Primària Camp de Tarragona; Institut Català de la Salut, Tarragona, Spain. earagones.tarte.ics@gencat.cat.|Institut Universitari d'Investigació en Atenció Primària (IDIAP) Jordi Gol, Barcelona, Spain. earagones.tarte.ics@gencat.cat.|Centre d'Atenció Primària de Constantí, Carrer dels Horts, 6, 43120, Tarragona, Constantí, Spain. earagones.tarte.ics@gencat.cat.
authors.forename: Enric
authors.identifier: 0000-0002-5245-4667
authors.initials: E
authors.lastname: Aragonès
authors.affiliation: Atenció Primària Camp de Tarragona; Institut Català de la Salut, Tarragona, Spain.|Institut Universitari d'Investigació en Atenció Primària (IDIAP) Jordi Gol, Barcelona, Spain.
authors.forename: Germán
authors.initials: G
authors.lastname: López-Cortacans
authors.affiliation: Atenció Primària Camp de Tarragona; Institut Català de la Salut, Tarragona, Spain.|Institut Universitari d'Investigació en Atenció Primària (IDIAP) Jordi Gol, Barcelona, Spain.
authors.forename: Antonia
authors.initials: A
authors.lastname: Caballero
authors.affiliation: Atenció Primària Terres de l'Ebre, Institut Català de la Salut, Tortosa, Spain.|Institut Universitari d'Investigació en Atenció Primària (IDIAP) Jordi Gol, Barcelona, Spain.
authors.forename: Josep Ll
authors.initials: JL
authors.lastname: Piñol
authors.affiliation: Chair in Pediatric Pain URV-Fundación Grünenthal and Unit for the Study and Treatment of Pain - ALGOS, Catalonia, Spain.|Research Center for Behavior Assessment (CRAMC), Department of Psychology, Universitat Rovira i Virgili, Catalonia, Spain.|Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira i Virgili, Catalonia, Spain.
authors.forename: Elisabet
authors.initials: E
authors.lastname: Sánchez-Rodríguez
authors.affiliation: Atenció Primària Camp de Tarragona; Institut Català de la Salut, Tarragona, Spain.|Institut Universitari d'Investigació en Atenció Primària (IDIAP) Jordi Gol, Barcelona, Spain.
authors.forename: Concepció
authors.initials: C
authors.lastname: Rambla
authors.affiliation: Chair in Pediatric Pain URV-Fundación Grünenthal and Unit for the Study and Treatment of Pain - ALGOS, Catalonia, Spain.|Research Center for Behavior Assessment (CRAMC), Department of Psychology, Universitat Rovira i Virgili, Catalonia, Spain.|Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira i Virgili, Catalonia, Spain.
authors.forename: Catarina
authors.initials: C
authors.lastname: Tomé-Pires
authors.affiliation: Chair in Pediatric Pain URV-Fundación Grünenthal and Unit for the Study and Treatment of Pain - ALGOS, Catalonia, Spain.|Research Center for Behavior Assessment (CRAMC), Department of Psychology, Universitat Rovira i Virgili, Catalonia, Spain.|Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira i Virgili, Catalonia, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Miró
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000928:Antidepressive Agents / Q000627:therapeutic use; D002985:Clinical Protocols; D016000:Cluster Analysis; D003863:Depression / Q000523:psychology / Q000628:therapy*; D003865:Major Depressive Disorder / Q000523:psychology / Q000628:therapy*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D059352:Musculoskeletal Pain / Q000523:psychology / Q000628:therapy*; D011320:Primary Health Care / Q000379:methods*; D011613:Psychotherapy / Q000379:methods*; D013030:Spain; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents
keywords: Care management; Depressive disorder; Musculoskeletal pain; Patient education; Primary health care