Psychosomatic therapy for patients frequently attending primary care with medically unexplained symptoms, the CORPUS trial: study protocol for a randomised controlled trial

Abstract

BackgroundMedically unexplained symptoms (MUS) are highly prevalent and pose a burden both on patients and on health care. In a pilot study psychosomatic therapy delivered by specialised therapists for patients with MUS showed promising results with regard to patient’s acceptability, feasibility and effects on symptoms. The aim of this study is to establish whether psychosomatic therapy by specialised psychosomatic exercise therapists is cost- effective in decreasing symptoms and improving functioning in patients who frequently consult their general practitioner (GP) with MUS.MethodsA randomised effectiveness trial with an economic evaluation in primary care with 158 patients aged 18 years and older who are frequently consulting their GP with MUS. Patients will be assigned to psychosomatic therapy in addition to usual care or usual care only. Psychosomatic therapy is a multi-component and tailored intervention, aiming to empower patients by applying psycho-education, relaxation techniques, mindfulness, cognitive approaches and/or graded activity. Patients assigned to the psychosomatic therapy receive 6 to 12 sessions of psychosomatic therapy, of 30–45 min each, delivered by a specialised exercise or physical therapist.Primary outcome measure is patient-specific functioning and disability, measured with the Patient-Specific Functional Scale (PSFS). Secondary outcome measures are symptom severity, consultation frequency and referrals to secondary care, patient satisfaction, quality of life and costs. Assessments will be carried out at baseline, and after 4 and 12 months.An economic evaluation alongside the trial will be conducted from a societal perspective, with quality-adjusted life years (QALYs) as outcome measure. Furthermore, a mixed-methods process evaluation will be conducted.DiscussionWe expect that psychosomatic therapy in primary care for patients who frequently attend the GP for MUS will improve symptoms and daily functioning and disability, while reducing consultation frequency and referrals to secondary care. We expect that the psychosomatic therapy provides value for money for patients with MUS.Trial registrationNetherlands Trial Register, ID: NL7157 (NTR7356). Registered 13 July 2018.

Perceived working mechanisms of psychosomatic therapy in patients with persistent somatic symptoms in primary care: a qualitative study

“…A more detailed description of the psychosomatic therapy (see online supplemental appendix 3 ) and methods of the CORPUS trial has been published elsewhere. 19 …”

“…18 Currently, we are performing a large randomised controlled trial (RCT), the CORPUS study, to establish the (cost-)effectiveness of psychosomatic therapy in patients with PSS in primary care. 19 Because this therapy is a complex, multimodal intervention, we conducted a process evaluation alongside the RCT. The aim of this study is to explore patients' and therapists' experiences with and views and opinions on the working mechanisms of the psychosomatic therapy.…”

“…A more detailed description of the psychosomatic therapy (see online supplemental appendix 3) and methods of the CORPUS trial has been published elsewhere. 19 The current study focuses on the qualitative part of the process evaluation of the CORPUS study. In order to obtain as rich in-depth data as possible, we conducted semistructured (in-depth) face-to-face interviews with patients who received psychosomatic therapy as well as their psychosomatic therapists.…”

Symptoms in family practice

“…Two guides for curriculum development were suggested. 14,15 Guidelines for handling symptoms do exist and they acknowledge that doctors do not commonly give explanations of symptoms to patients. 16 Perhaps this is because they simply do not have enough family practice-based information; for example, data on how long an uncomplicated cough may last.…”

Les symptômes en pratique familiale

“…Compte tenu de l'omniprésence des symptômes en pratique familiale, les conférenciers ont fait valoir que l'éducation sur les symptômes devrait figurer parmi les grandes priorités des programmes d'études en médecine et de résidence. Ils ont proposé 2 guides sur l'élaboration des cursus 14,15 . Il existe effectivement des lignes directrices, et ces guides reconnaissent que les médecins n'expliquent souvent pas les symptômes aux patients 16 .…”