Cognitive-behavioural intervention in primary care for undifferentiated somatoform disorder
- Conditions
- medically unexplained physical symptoms (MUPS), undifferentiated somatoform disorder (USD)
- Registration Number
- NL-OMON24561
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Design paper: Sitnikova K, Leone SS, Zonneveld LNL, van Marwijk HWJ, Bosmans JE, van der Wouden JC, van der Horst HE. The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial. Trials. 2017;18(1):206. Main results: Sitnikova K, Leone SS, van Marwijk HWJ, Twisk J, van der Horst HE, van der Wouden JC. Effectiveness of a cognitive behavioural intervention for patients with undifferentiated somatoform disorder: Results from the CIPRUS cluster randomized controlled trial in primary care. J Psychosom Res. 2019 Jun 24:109745. Economic evaluation: Forthcoming.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 212
1) Being 18 years of age or older
2) Meeting the criteria for undifferentiated somatoform disorder according to DSM IV:
1) Having a medical disorder that explains the symptoms
2) Having a severe psychiatric disorder (i.e. psychosis-related disorders,
dementia and bipolar disorder)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary clinical outcome is the development in physical functioning along the total follow-up period as measured by the physical component summary (PCS) of the RAND-36.<br><br /><br /><br>The primary outcome measure for the economic evaluation is quality of life as measured by the EuroQol/EQ-5D. Direct and indirect costs will be assessed with the TIC-P 20 and data on health care use extracted from the electronic medical records of the GPs. Direct costs will be based on the Dutch standard cost prices and the indirect costs will be estimated based on the average of the population.
- Secondary Outcome Measures
Name Time Method Secondary outcome measures are the severity of somatisation (PHQ-15) and<br>depressive/anxiety symptoms (HADS).