Sitnikova 2014.

Trial name or title	CIPRUS ‐ Cognitive‐behavioural intervention in primary care for undifferentiated somatoform disorder
Methods	Randomised controlled study in general practice
Participants	Inclusion criteria: 1) Being 18 years of age or older 2) Meeting the criteria for undifferentiated somatoform disorder according to DSM IV: a) The presence of ≥ 1 medically unexplained physical symptoms b) The symptoms last at least 6 months c) The symptoms significantly impair functioning/quality of life Exclusion criteria: 1) Having a medical disorder that explains the symptoms 2) Having a severe psychiatric disorder (i.e. psychosis‐related disorders, dementia and bipolar disorder) 3) Having a handicap such as cognitive mental impairment and/or blindness 4) Being unable to speak or read Dutch
Interventions	Mental health nurse practitioners (MHNP) will offer intervention participants a short structured intervention based on cognitive‐behavioural (CB) principles, in addition to usual GP care, to teach participants how to cope with the consequences of their symptoms. In up to 6 sessions participants will be provided with psycho‐education, problem solving techniques, relaxation techniques, and activity scheduling. The consequences model of somatoform complaints has successfully been used in previous Dutch intervention studies and focuses on the consequences or problems that arise due to somatoform complaints and on their aggravating effects, rather than on causes of somatoform complaints. This model will be used as the treatment rationale. The focus is not so much on treating the symptoms, but rather on producing beneficial changes in (physical) functional outcome and quality of life. The MHNPs provide the CB approach of problem solving treatment (PST) as a means to learn to tackle and cope with the identified consequences. PST teaches problem‐solving styles and skills. Several steps to problem solving have been described which will be practised during the sessions: 1. explanation of treatment rationale and 'contracting', 2. identification and clarification of problems, 3. the setting of clear goals, 4. formulation of alternative solutions, 5. selection of preferred solutions, 6. clarification of the necessary steps to implement solutions, and 7. evaluation of progress. In addition, activity scheduling and progressive relaxation techniques will be provided as these are important general features of CBT for somatoform complaints. Participants in the control group will not be offered a specific additional intervention other than the care they would usually receive from the GP
Outcomes	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 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 healthcare 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 are the severity of somatisation (PHQ‐15) and depressive/anxiety symptoms (HADS)
Starting date	2014
Contact information	Kate Sitnikova, VUmc Amsterdam, Netherlands, email e.sitnikova@vumc.nl, phone +31204448032
Notes	Dutch Trial Register, identifier NTR4686