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van CCT (UK)

van CCT (UK)

Cognitive-behavioural intervention in primary care for undifferentiated somatoform disorder

- candidate number18366
- NTR NumberNTR4686
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jul-2014
- Secondary IDsZonMw dossier number 80-83700-98-42070
- Public TitleCognitive-behavioural intervention in primary care for undifferentiated somatoform disorder
- Scientific TitleCost-effectiveness of a short-term cognitive-behavioural intervention by mental health nurse practitioners for primary care patients with an undifferentiated somatoform disorder
- hypothesisWe expect that the intervention will improve physical functioning, will be more cost-effective, and will reduce somatisation, depression and anxiety symptoms.
- Healt Condition(s) or Problem(s) studiedMedically unexplained physical symptoms
- Inclusion criteria1) Being 18 years of age or older
2) Meeting the criteria for undifferentiated somatoform disorder according to DSM IV:
a) The presence of 1 or more medically unexplained physical symptoms
b) The symptoms last at least 6 months
c) The symptoms significantly impair functioning/quality of life
- Exclusion criteria1) 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2014
- planned closingdate1-apr-2018
- Target number of participants240
- InterventionsMental 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.
- Primary outcomeThe 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 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 outcomeSecondary outcome measures are the severity of somatisation (PHQ-15) and depressive/anxiety symptoms (HADS).
- Timepoints0, 2, 4 and 12 months after baseline
- Trial web site
- statusplanned
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryCognitive-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, 120 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.

We expect the intervention to improve physical functioning and be more cost-effective. If this is the case, more patients are likely to be reached within the primary care setting, their symptoms are likely to diminish and costs might be reduced.
- Main changes (audit trail)
- RECORD14-jul-2014 - 11-aug-2014

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