Transmural Collaborative Care: Integrated antidepressant and psychotherapeutic treatment of concomitant pain and depressive disorder.

The burden of pain and depression is high 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 is low. Also, physical symptoms, including pain, in major depressive disorder, predict a poorer response to treatment. A multi-faceted, patient-tailored treatment programme, such as collaborative care, is needed. However, treatment of chronic pain conditions in depressive patients has, so far, not received much attention. Also, cost effectiveness of an integrated approach of pain in depressed patients has not been studied yet.

This article describes the aims and design of a study that is currently underway. The aim of this study is to evaluate effects and costs of collaborative care with Duloxetine for patients with pain symptoms and a depressive disorder, compared to mono-treatment (collaborative care with placebo, Duloxetine alone).

This study is a placebo controlled double blind, three armed randomized Multi Centre trial with a factorial design. Patients with (sub) chronic pain and a depressive disorder will be included. They will be randomized to either collaborative care with Duloxetine, collaborative care with placebo, or Duloxetine alone. In the collaborative care conditions, the care-manager will provide Problem Solving Treatment and guidance with a self-help manual. The care-manager is also responsible for monitoring of depressive and pain symptoms. Also, patients are referred to a physiotherapist. Here, they will receive treatment according to a 'Graded Activity' protocol. The psychiatrist is responsible for the medication. According to an antidepressant algorithm, the psychiatrist prescribes an antidepressant (Duloxetine or placebo). For the pain medication, a pain medication algorithm will be followed. The psychiatrist will also monitor progress of pain and depressive symptoms. After 12 weeks, the patient will be referred back to the general practitioner with a Consultation Letter. This letter contains information for further treatment of the patient. 189 completers are needed to attain sufficient power to show a clinically significant effect of 0.6 SD on the primary outcome measures. Data on depression, anxiety, mental and physical health, medication adherence, 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.

Combined treatment (collaborative care + duloxetine) is more effective than mono-treatment (duloxetine or collaborative care + placebo) in depressive symptom reduction on the PHQ as main outcome for patients with MDD and (sub)chronic pain.

Assessments: T0 at baseline; T1 at 3 months, T2 at 6 months, T3 at 9 months and T4 at 12 months.

Experimental intervention will be integrated care including psychoeducation with DVD developed specifically on depression and pain; a self-help manual with psycho education and exercises (i.e. relaxation techniques); a pain medication protocol; an antidepressant protocol, consisting of an algorithm for Duloxetine; Problem Solving Treatment; Graded Activity, provided by a physiotherapist; a Consultation Letter to the PCP. The control group will be treated with Duloxetine according to the antidepressant protocol with Duloxetine algorithm. The third group will receive a placebo plus integrated care as mentioned above.