| Methods |
RCT to compare two conditions.
Randomisation on patient level according to randomised consent design. Assessments on four occasions: baseline, 4, 8 and 12 months. |
| Participants |
151 patients (aged 18‐65) with severe fatigue (CIS =>35) and complete absenteeism (6‐26 weeks), recruited from an occupational health service.
Therapists: 9 research GPs. |
| Interventions |
T (n:76) = brief ‐cognitive behavioural therapy, 5‐7 30‐min sessions in 4 months.
C (n:75) = no treatment or usual care by own GP.
Therapists (GPs) received 10‐h training in CBT (workshops, role playing), use of training manual, 2‐monthly supervision by experienced behaviour therapist throughout trial. |
| Outcomes |
At all time points (4,8, and 12 months): no sign. differences between groups on fatigue (CIS), absenteeism, clinical recovery (reduced fatigue plus work resumption) or any other outcome.
Recovered cases (CIS <35 plus work resumption): T=23/76, C=29/75 (no significant differences). |
| Notes |
non‐compliance: T=20/76
withdrawal: T=6/76, C=7/76 (12 months)
integrity check performed and published. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
