Miro 2011.
| Methods |
Study setting: Europe (Spain). Single centre, university rheumatology and pain department, outpatient based Study design: Randomized, parallel Duration therapy: 6 weeks Follow‐up: No Analysis: T‐test, Mann‐Whitney U, Chi² to compare baseline measures, ANCOVA 2 (alerting signal) x 3 (orienting cue) x 2 (congruency) x 2 (time) with age as covariate, repeated measures ANOVA (CBT vs SH x time, pre vs post‐treatment), calculation of effect sizes (Cohen’s d), paired comparisons of sign. effects with student’s t test, Reliable Change Index for clinical variables that changed over time as a result of therapy and Pearson’s analysis |
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| Participants |
Patients: Treatment Group: 20 patients, 100% female, race not reported, mean age 44.0 years; duration FMS 4.2 (3.4) years Control Group: 20 patients, 100% female, race not reported, mean age 50.2 years; duration FMS 4.7 (4.3) years Inclusion: ACR 1990 criteria for FM, criteria for insomnia Exclusion: 25 to 60 years, insomnia/cognitive dysfunction were better explained by being pregnant, medical history of significant head injury, neurological disorder, major concomitant medical condition, major depressive disorder with suicide ideation, other major axis I diagnosis, symptoms of sleep disruptive co‐morbidities with insomnia, apnoea‐hypopnoea index or periodic limb movement‐related arousal index of 15 or more per hour of sleep, severe hypnotic dependence (use of hypnotic in a higher than recommended dosage or repeated episodes of rebound insomnia on withdrawal), being treated with another psychological or physical therapy at the moment of the study |
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| Interventions |
Treatment Group: CBT, group: Education, sleep restriction, stimulus control instructions, relaxation training, cognitive therapy for dysfunctional beliefs related to insomnia (1.5h/week), total: 9h Control Group: Active control: Sleep hygiene, group: education sleep hygiene rules (1,5h/wk), total: 9h Co‐medication allowed: Stable doses of medication Other Co‐therapies: None |
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| Outcomes |
Primary Outcomes Self reported pain: MPQ VAS pain 1‐10 Self reported negative mood: Hospital Anxiety and Depression Scale (HADS) subscale depression 0‐21 Self reported disability: FIQ impairment 0‐10 not reported and not provided on request Acceptability: Total dropout rate Secondary Outcomes Self reported self efficacy pain: Not assessed Self reported fatigue: FIQ fatigue 0‐10 not reported and not provided on request Self reported sleep problems: Pittsburgh Sleep Quality Index (PSQI) 0‐21 Self reported disease‐specific health‐related quality of life: FIQ 0‐100 |
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| Notes | 1. Reasons for dropout: ‐Treatment Group: 1x did not receive CBT due to changes in work time, 1x did not attend assessment at end of treatment ‐ Control Group: 2x did not attend assessment at end of treatment 2: Attendance rates: Not reported 3. Responder analysis: 60% of patients in the CBT‐group and 30% of the patients in the control group clinically significant (% not reported) reduction of the FIQ daily functioning score at end of treatment 4. Funding sources and declaration of interest of the primary researchers: The study was financially supported by the Spanish Ministry of Science and Innovation (research projects SEJ2006‐07513, PSI2008‐03595PSIC and PSI2009‐1365PSIC) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Simple randomisation (1:1) was implemented by a computerised number generator designed by a researcher with no clinical involvement in the trial |
| Allocation concealment (selection bias) | Low risk | Yes (see above) |
| Incomplete outcome data (attrition bias) All outcomes | High risk | No intention‐to‐treat analysis |
| Selective reporting (reporting bias) | High risk | Not all outcomes reported and not provided on request |
| Blinding of outcome assessor | Low risk | The assessment of the outcome measures was performed by an examiner who was blinded to group assignment |