Cognitive-behavioural intervention in primary care for undifferentiated somatoform disorder

Cost-effectiveness of a short-term cognitive-behavioural intervention by mental health nurse practitioners for primary care patients with an undifferentiated somatoform disorder

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24561

Enrollment

212

Registered

2014-07-14

Start date

2014-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

medically unexplained physical symptoms (MUPS), undifferentiated somatoform disorder (USD)

Interventions

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 partici

Eligibility

Inclusion criteria

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 or more medically unexplained physical symptoms b) The symptoms last at least 6 months c) The symptoms significantly impair functioning/quality of life

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 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.	—

Measure

Time frame

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 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.

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Secondary

Measure	Time frame
Secondary outcome measures are the severity of somatisation (PHQ-15) and depressive/anxiety symptoms (HADS).	—

Contacts

Public ContactHans van der Wouden

Amsterdam UMC, Vrije Universiteit, Amsterdam Public Health research institute

j.vanderwouden@amsterdamumc.nl+31204448167

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)