Psychosomatic therapy for patients with medically unexplained symptoms
Not yet recruiting
- Conditions
- Medically unexplained symptoms (MUS)Somatisch onvoldoende verklaarde lichamelijke klachten (SOLK)
- Registration Number
- NL-OMON27191
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 158
Inclusion Criteria
The target population includes primary care patients aged 18-80 years who frequently, i.e. twice or more in the last 3 months, consult their GP for MUS. Patients should have a PHQ-15 score of >/= 5.
Exclusion Criteria
Exclusion criteria are receiving palliative care, having a severe psychiatric disorder (i.e. psychosis-related disorders, dementia and bipolar disorder), mental retardation, visual impairment, illiteracy, insufficient understanding of the Dutch language.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary clinical outcome is patients’ level of specific functioning and disability measured with the patient-specific functional scale (PSFS). <br /><br> <br /><br>The primary outcome measure for the economic evaluation is quality of life assessed by the SF-6D, which will be derived from the SF-36. Health care costs, medical consumption and work limitations will be assessed with the Medical Consumption Questionnaire (iMCQ) and work limitations with the Productivity Cost Questionnaire (iPCQ).
- Secondary Outcome Measures
Name Time Method Perceived symptom severity (NRS); Self-rated symptoms of distress, depression, anxiety and somatization (4DSQ); Physical and mental health status and quality of life (SF-36); Health anxiety, illness behaviour and illness beliefs (resp. IAS and IPQ-K); Patients' perceived recovery and satisfaction with the psychosomatic therapy (GPE); number of GP consults.