Condition category
Mental and Behavioural Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
15/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ingrid A. Arnold

ORCID ID

Contact details

Department of Public Health and Primary Care.
Leiden University Medical Center
P.O. Box 2088
Leiden
2301 CB
Netherlands
+31 (0)71 5275318
i.a.arnold@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR148; 940-38-013

Study information

Scientific title

Acronym

SOUL

Study hypothesis

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

Received from the local medical ethics committee

Study design

Randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/04/2000

Overall trial end date

01/06/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

65

Participant 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

Recruitment start date

01/04/2000

Recruitment end date

01/06/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Public Health and Primary Care.
Leiden
2301 CB
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (Netherlands)

Sponsor details

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

University/education

Website

http://www.lumc.nl/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes