| Study characteristics |
| Methods |
Risk of bias:
1. Sequence generation: low ‐ computer generated combinations in blocks of 10
2. Allocation concealment: low ‐ opaque sealed envelopes, taken in sequence to each baseline assessment and opened in front of the patient
3. Blinding: low ‐ self‐report measures, completed by post
4. Incomplete outcome data: uncertain ‐ high dropout rate and reasons for dropout not reported; sensitivity and intention‐to‐treat analyses reported
5. Selective outcome reporting: uncertain ‐ study protocol not available but no results presented for SF‐36 scores
6. Other sources of bias: uncertain ‐ although counselling was selected as anactive comparison, the hypothesis was that CBT would be more effective ‐ the manner of report of eventual equivalence suggests author allegiance to the cognitive behavioural paradigm; subgroup analysis of CFS participants appears post‐hoc |
| Participants |
Setting: primary care; general practices
Sample population: all patients meeting study criteria referred by GPs complaining of fatigue as main or important problem
Sample size: 160
Inclusion criteria: greater than 3 months fatigue as indexed by score of 4 or more on Chalder fatigue scale
Exclusion criteria: outside study age range (16 to 75 years), three months or more duration of fatigue, abnormal FBC/ESR/TFTs within previous 6 months, concurrent physical problems judged to be cause of fatigue, recent change in drug regimen, psychotic illness, unable to read English, learning difficulty precluding completion of questionnaire, concurrent psychological/psychiatric treatment, patient unable to attend
Baseline characteristics: no testing for differences on pre‐treatment demographic, psychiatric, or outcome variables |
| Interventions |
1: 'counselling'; qualified counsellors offering psychodynamic approach
2: 'cognitive behaviour therapy'; individual; 6 treatments of 60 minutes over period unspecified period; manualised; treatment fidelity assessed by independent rating of sampling of recorded sessions; therapists were qualified CBT therapists (supervised during trial); used activity planning, consistent and realistic activity given patient's responsibilities, addressed negative self‐beliefs, expectations, self‐esteem, establishment of sleep routine, and relapse prevention |
| Outcomes |
1. MEASURES: Chalder fatigue score, number of cases of fatigue on Chalder fatigue score, HADS Anxiety, HADS depression, on antidepressants, social adjustment score, satisfaction with therapy
2. FOLLOW‐UP TIMES: 3 months, 6 months (duration of treatment not specified) |
| Notes |
Mean duration of fatigue approximately 27 months; 44% of sample met CDC criteria for CFS |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
opaque sealed envelopes, taken in sequence to each baseline assessment and opened in front of the patient |
