| Study characteristics |
| Methods |
Risk of bias:
1. Sequence generation: uncertain ‐ not specified
2. Allocation concealment: uncertain ‐ not specified
3. Blinding: high ‐ self‐report or physiological measures except stepping test with blinding unspecified; no information on procedure for collecting post‐treatment questionnaires; delayed expectations of wait list control group vulnerrable to reponse bias
4. Incomplete outcome data: uncertain ‐ low dropout rate and reasons specified, but no sensitivity analysis
5. Selective outcome reporting: uncertain ‐ not specified
6. Other sources of bias: high ‐ recruitment based on referrals from physicians/local support groups with possible selection bias; inequivalence of groups at baseline (see below); no testing of treatment fidelity reported |
| Participants |
Setting: secondary care ‐ exact setting unclear
Sample population: recruited from physicians or local CFS groups
Sample size: 29
Inclusion criteria: CDC criteria
Exclusion criteria: organic aetiology for condition identified by GP in previous 12 months
Baseline characteristics: no differences on psychiatric or demographic variables reported except control group significantly more likely to have received a diagnosis of fibromyalgia; comparison groups similar pre‐treatment on outcome variables except intervention group had more morning insomnia, awoke more at night, had worse SF‐36 scores and outperformed control group on stepping test |
| Interventions |
1:'chronobiological treatment programme'; individual; 8 sessions of 60 minutes over 9 weeks; manualisation not specified; treatment fidelity not specified; therapists were doctoral level psychologist or 4 'trained assistants' (supervision not specified); used sleep hygiene education, biofeedback assisted relaxation, breathing retraining, graded aerobic exercise, and cognitive therapy; diary keeping and home based‐exercise programme
2:'wait‐list control'; no intervention sessions |
| Outcomes |
1. MEASURES: moderate‐hard exercise (hrs/wk), relaxation hrs/wk, stress hrs/day), nighttime insomnia, morning insomnia, nights per week awakening at night, CESD (center for epidemiological studies depression score), POMS Profile of Moods Scale total score/fatigue score/vigour score, SF‐36 physical functioning subscale/mental health subscale, CFS symptoms check‐list score, forehead EMG, temperature, heart rate, breaths per minute, electrodermal response, amplitude, end tidal carbon dioxide, exercise test step duration exercise test step level, exercise test rate of perceived exertion
2. FOLLOW‐UP TIMES: 9 weeks (1 week post‐treatment) |
| Notes |
Mean duration of fatigue not specified |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
not specified |
