Olde Hartman 2013.

Trial name or title	Psychosomatic Therapy, Feasibility and Cost Analysis (PsySom)
Methods	Randomised pilot study consisting of participants with MUS in primary care. Participants will be followed for 1 year
Participants	People with MUS
Interventions	Participants will be randomised to intervention (usual care and additional psychosomatic therapy) or control condition (usual care alone)
Outcomes	Primary outcome measures are: the number of participants identified and recruited, perceived symptom severity, measured on a Visual Analogue Scale (VAS) and participants' self rated symptoms of distress, depression, anxiety and somatisation (4DSQ: The Four Dimensional Symptom Questionnaire). Other primary outcome measures are the time needed to include the eligible participants, the number of withdrawals in the intervention and control group, compliance in the therapy group and the number of participants who complete the questionnaires Secondary outcome measures are: symptoms of hyperventilation (NHL: Nijmegen Hyperventilation List), physical and mental health status and quality of life (SF‐36), and level of functioning (MAF: measure of general functioning). Participant satisfaction with the received therapy is rated on a 5‐point Likert‐type scale. Medical consumption will be measured by the Cost Diary for medical consumption
Starting date	April 2013
Contact information	Dr T.C. olde Hartman, Radboud University, email: Tim.OldeHartman@radboudumc.nl
Notes	ClinicalTrials.gov Identifier: NCT01935258. Results expected Octiver 2014