Cognitive-behavioural intervention in primary care for undifferentiated somatoform disorder

Cognitive-behavioural (CB) interventions decrease undifferentiated somatoform disorder (USD) symptoms and improve functioning in secondary care. To date it is, however, unknown whether a short-term CB intervention for USD, provided by a primary care mental health care practitioner (MHNP) is (cost-)effective compared to usual care.



In a cluster randomised controlled trial, with randomisation on MHNP level, 212 adult USD patients will be assigned to either the intervention or control group. The intervention group will be offered a short-term CB intervention in addition to usual GP care. The treatment rationale is the consequences model focusing on the consequences or problems that arise due to the USD. In 6 sessions patients will receive psycho-education, problem solving techniques, activity scheduling and relaxation techniques, to learn to cope with identified problems. The control group will receive usual GP care. The intervention aims to enhance physical (role) functioning as measured by the physical component summary of the RAND-36. An economic evaluation will also be conducted with quality of life as a primary outcome measure, assessed by the EQ-5D. Direct and indirect costs will be assessed with the TIC-P. Secondary outcomes include somatisation (PHQ-15) and symptoms of depression and anxiety (HADS). Assessments will be taken at 0, 2, 4 and 12 months.



Recruitment started in August 2015 and was completed March 2017. Follow-up measurements were completed in April 2018.
For main results see PubMed: PMID: 31285038

We expect that the intervention will improve physical functioning, will be more cost-effective, and will reduce somatisation, depression and anxiety symptoms.

0, 2, 4 and 12 months after baseline

Mental health nurse practitioners (MHNP) will offer intervention patients 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 patients 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.

Patients in the control group will not be offered a specific additional intervention other than the care they would usually receive from the GP.