Medically unexplained physical symptoms in primary care: a controlled study on the effectiveness of cognitive-behavioural treatment by the general practitioner

ISRCTN	ISRCTN89623328
DOI	https://doi.org/10.1186/ISRCTN89623328
Protocol serial number	NTR148; 940-38-013
Sponsor	Leiden University Medical Centre (LUMC) (Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Ingrid A. Arnold
Scientific

Department of Public Health and Primary Care.
Leiden University Medical Center
P.O. Box 2088
Leiden
2301 CB
Netherlands

Phone	+31 (0)71 5275318
Email	i.a.arnold@lumc.nl

Primary study design	Interventional
Study design	Randomised active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SOUL
Study objectives	A cognitive-behavioural intervention provided by the GP will be more effective in reducing somatic symptoms and functional impairment in medically unexplained physical symptoms than care as usual.
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Somatoform disorder
Intervention	Care as usual plus an additional five sessions of 45 minutes of cognitive-behavioural therapy with their general practitioner compared with care as usual.
Intervention type	Other
Primary outcome measure(s)	1. Severity of the main physical symptom as indicated on a VAS and the self-rated improvement of symptoms at 6 and 12 months follow-up 2. Recovery was defined as a decrease of at least 30% on the VAS for the severity of the main physical symptom
Key secondary outcome measure(s)	1. Self-reported physical symptoms (PSC) 2. Anxiety and depressive symptoms (HADS) 3. Functional limitations (SF-36) 4. Health anxiety and behaviour (IAS) 5. Health care utilisation
Completion date	01/06/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	65
Key inclusion criteria	1. The presence of a somatoform disorder 2. A minimum score of 5 for the main unexplained physical symptom on a Visual Analogue Scale (VAS - range 0 - 10) 3. Written informed consent
Key exclusion criteria	1. Unable to participate in treatment due to handicaps such as deafness, aphasia or cognitive impairment 2. Ongoing psychological treatment 3. Serious somatic disease 4. Serious psychiatric disorder such as psychosis, substance abuse, post-traumatic stress disorder or severe personality disorder
Date of first enrolment	01/04/2000
Date of final enrolment	01/06/2004

Department of Public Health and Primary Care.

Leiden
2301 CB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan