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.
Bron
Verkorte titel
Aandoening
1. Somatoform disorder;
2. medically unexplained physical symptoms.
Ondersteuning
Leiden Lniversity Medical Center
POBox 2088
2301 CB Leiden
The Netherlands
nr. 940-38-013
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
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.<br> Recovery was defined as a decrease of at least 30% on the VAS for the severity of the main physical symptom.
Achtergrond van het onderzoek
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.
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Care as usual plus an additional five sessions of 45 minutes of cognitive-behavioural therapy with their general practitioner compared with care as usual.
Publiek
P.O. Box 2088
I.A. Arnold
Leiden 2301 CB
The Netherlands
+31 (0)71 5275318
i.a.arnold@lumc.nl
Wetenschappelijk
P.O. Box 2088
I.A. Arnold
Leiden 2301 CB
The Netherlands
+31 (0)71 5275318
i.a.arnold@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL116 |
NTR-old | NTR148 |
Ander register | : 940-38-013 |
ISRCTN | ISRCTN89623328 |