Background: Medically 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 costeffective in decreasing symptoms and improving functioning in patients who frequently consult their general
practitioner (GP) with MUS. Methods: A 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. Discussion: We 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 registration: Netherlands Trial Register, ID: NL7157 (NTR7356). Registered 13 July 2018.Keywords: Psychosomatic therapy, Study protocol, Primary care, Randomised controlled trial, Medically unexplained
symptoms, Cost-effectiveness