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


- candidate number1242
- NTR NumberNTR148
- ISRCTNISRCTN89623328
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR25-aug-2005
- Secondary IDs940-38-013 
- Public TitleMedically unexplained physical symptoms in primary care: a controlled study on the effectiveness of cognitive-behavioural treatment by the general practitioner.
- Scientific TitleMedically unexplained physical symptoms in primary care: a controlled study on the effectiveness of cognitive-behavioural treatment by the general practitioner.
- ACRONYMSOUL
- hypothesisA 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.
- Healt Condition(s) or Problem(s) studiedSomatoform disorder, Medically unexplained physical symptoms
- Inclusion criteria 1. The presence of a somatoform disorder;
2. A minimum score of 5 for the main unexplained physical symptom on a VAS (range 0-10) and;
3. Written informed consent.
- Exclusion criteria1. Unable to participate in treatment due to handicaps such as deafness, aphasia or cognitive impairment;
2. Ongoing psychological treatment;
3. A serious somatic disease or ;
4. A serious psychiatric disorder such as psychosis, substance abuse, post-traumatic stress disorder or severe personality disorder.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2000
- planned closingdate1-jun-2004
- Target number of participants65
- InterventionsCare as usual plus an additional five sessions of 45 minutes of cognitive-behavioural therapy with their general practitioner compared with care as usual.
- Primary outcomeSeverity of the main physical symptom as indicated on a VAS and the self-rated improvement of symptoms at 6 and 12 months follow-up.
Recovery was defined as a decrease of at least 30% on the VAS for the severity of the main physical symptom.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES I.A. Arnold
- CONTACT for SCIENTIFIC QUERIES I.A. Arnold
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of General Practice
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryObjectives:
To assess the effectiveness of a primary care cognitive-behavioural treatment for somatoform disorders.
Our main hypothesis was that a cognitive-behavioural intervention provided by the GP would be more effective in reducing somatic symptoms and functional impairment than care as usual.


Design:
Controlled study. Care as usual was compared with care as usual plus an additional cognitive-behavioural intervention by a trained GP as therapist.


Setting:
16 general practices in the Western part of The Netherlands


Participants:
1,830 attendees and 4,579 listed patients underwent a two-step screening with a postal questionnaire and a psychiatric diagnostic interview (WHO-SCAN 2.1).
After 6 months participants with a DSM-IV somatoform disorder were assessed on eligibility for cognitive-behavioural treatment.


Exclusion criteria:
serious psychiatric or somatic disease or current psychological treatment. 100 participants were eligible, and 65 agreed to participated, 31 in the intervention and 34 in the control condition.


Interventions:
Intervention patients were offered five 45-minute sessions of cognitive-behavioural treatment by their GP as an additional intervention to care as usual. In the control condition participants received care as usual.


Main outcome measures:
The severity of the main physical symptom as indicated on a visual analogue scale (VAS) and the self-reported recovery of symptoms (better/same/worse) at 6 and 12 months after baseline.


Results:
The average severity score of the main physical symptom on a VAS decreased from 7.6 at baseline to 6.0 (CI 5.2-6.8) for controls and 6.0 (CI 5.1-6.8) for intervention participants after 12 months.
According to their self-reported recovery, 12 out of 34 controls (35%) and 13 out of 31 intervention patients (42%) indicated improvement of symptoms, which was not significantly different.
Secondary outcome measures did not show significant differences either. The prescription of psychotropic drugs was associated with better recovery.


Conclusions:
We found no additional advantage of 5 sessions of cognitive-behavioural therapy to care as usual.
A possible explanation for the lack of effectiveness is that the treatment was brief and carried out by a general practitioner. Furthermore, in comparison with secondary care studies, the participants in this study were older and had relatively severe symptoms.
- Main changes (audit trail)
- RECORD18-aug-2005 - 12-jun-2008


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