|- candidate number||1242|
|- NTR Number||NTR148|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||25-aug-2005|
|- Secondary IDs||940-38-013 |
|- Public Title||Medically unexplained physical symptoms in primary care: a controlled study on the effectiveness of cognitive-behavioural treatment by the general practitioner.|
|- Scientific Title||Medically unexplained physical symptoms in primary care: a controlled study on the effectiveness of cognitive-behavioural treatment by the general practitioner.|
|- 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. |
|- Healt Condition(s) or Problem(s) studied||Somatoform 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 criteria||1. 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 received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2000|
|- planned closingdate||1-jun-2004|
|- Target number of participants||65|
|- Interventions||Care as usual plus an additional five sessions of 45 minutes of cognitive-behavioural therapy with their general practitioner compared with care as usual.|
|- Primary outcome||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.|
Recovery was defined as a decrease of at least 30% on the VAS for the severity of the main physical symptom.
|- Secondary outcome||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.
|- Trial web site||N/A|
|- status||inclusion 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|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Objectives: |
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.
Controlled study. Care as usual was compared with care as usual plus an additional cognitive-behavioural intervention by a trained GP as therapist.
16 general practices in the Western part of The Netherlands
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.
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.
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.
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.
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)|
|- RECORD||18-aug-2005 - 12-jun-2008|