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 |
| Secondary identifying numbers | NTR148; 940-38-013 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 15/05/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
Contact information
Dr Ingrid A. Arnold
Scientific
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 |
|---|---|
| i.a.arnold@lumc.nl |
Study information
| Study design | Randomised active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| 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 | 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 study start date | 01/04/2000 |
| Completion date | 01/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Department of Public Health and Primary Care.
Leiden
2301 CB
Netherlands
2301 CB
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (Netherlands)
University/education
University/education
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/ |
|---|---|
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
