title: Effectiveness and cost-effectiveness of transmural collaborative care with consultation letter (TCCCL) and duloxetine for major depressive disorder (MDD) and (sub)chronic pain in collaboration with primary care: design of a randomized placebo-controlled multi-Centre trial: TCC:PAINDIP.
abstract: BACKGROUND
  The comorbidity of pain and depression is associated with high disease burden for patients in terms of disability, wellbeing, and use of medical care. Patients with major and minor depression often present themselves with pain to a general practitioner and recognition of depression in such cases is low, but evolving. Also, physical symptoms, including pain, in major depressive disorder, predict a poorer response to treatment. A multi-faceted, patient-tailored treatment programme, like collaborative care, is promising. However, treatment of chronic pain conditions in depressive patients has, so far, received limited attention in research. Cost effectiveness of an integrated approach of pain in depressed patients has not been studied.
  
  
  METHODS
  This study is a placebo controlled double blind, three armed randomized multi centre trial. Patients with (sub)chronic pain and a depressive disorder are randomized to either a) collaborative care with duloxetine, b) collaborative care with placebo or c) duloxetine alone. 189 completers are needed to attain sufficient power to show a clinically significant effect of 0.6 SD on the primary outcome measures (PHQ-9 score). Data on depression, anxiety, mental and physical health, medication adherence, medication tolerability, quality of life, patient-doctor relationship, coping, health resource use and productivity will be collected at baseline and after three, six, nine and twelve months.
  
  
  CONCLUSIONS
  This study enables us to show the value of a closely monitored integrated treatment model above usual pharmacological treatment. Furthermore, a comparison with a placebo arm enables us to evaluate effectiveness of duloxetine in this population in a real life setting. Also, this study will provide evidence-based treatments and tools for their implementation in practice. This will facilitate generalization and implementation of results of this study. Moreover, patients included in this study are screened for pain symptoms, differentiating between nociceptive and neuropathic pain. Therefore, pain relief can be thoroughly evaluated.
  
  
  BACKGROUND
  NTR1089.
authors.forename: Eric W
authors.initials: EW
authors.lastname: de Heer
authors.forename: Jack
authors.initials: J
authors.lastname: Dekker
authors.forename: Jonna F
authors.initials: JF
authors.lastname: van Eck van der Sluijs
authors.forename: Aartjan Tf
authors.initials: AT
authors.lastname: Beekman
authors.forename: Harm Wj
authors.initials: HW
authors.lastname: van Marwijk
authors.forename: Tjalling J
authors.initials: TJ
authors.lastname: Holwerda
authors.forename: Pierre M
authors.initials: PM
authors.lastname: Bet
authors.forename: Joost
authors.initials: J
authors.lastname: Roth
authors.forename: Leona
authors.initials: L
authors.lastname: Hakkaart-Van Roijen
authors.forename: Lianne
authors.initials: L
authors.lastname: Ringoir
authors.forename: Fiona
authors.initials: F
authors.lastname: Kat
authors.forename: Christina M
authors.initials: CM
authors.lastname: van der Feltz-Cornelis
mesh_terms: D000223:Adaptation, Psychological; D000928:Antidepressive Agents / Q000191:economics / Q000627:therapeutic use*; D059350:Chronic Pain / Q000150:complications / Q000188:drug therapy* / Q000191:economics; D003362:Cost-Benefit Analysis; D003865:Major Depressive Disorder / Q000150:complications / Q000188:drug therapy* / Q000191:economics; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D006801:Humans; D010348:Patient Care Team; D011320:Primary Health Care; D011788:Quality of Life; D012017:Referral and Consultation; D012107:Research Design; D012648:Self Care; D013876:Thiophenes / Q000191:economics / Q000627:therapeutic use*
chemical_list: D000928:Antidepressive Agents; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride