Schmidt 2011.
| Methods | RCT; 3 arms; mindfulness‐based stress reduction, active relaxation control, waiting list; post‐treatment, 2‐month follow‐up | |
| Participants | End of treatment n = 148 Start of treatment n = 177 Sex: 177 F; 0 M Mean age = 52.5 (SD 9.6) Source = newspapers, GP and specialist referrals, patient self help groups Diagnosis = fibromyalgia Mean years of pain: 4.0 (SD 3.9) |
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| Interventions | Mindfulness‐based stress reduction; active control (relaxation, support and education); waiting list | |
| Outcomes |
Primary pain outcome: Pain Perception Scale (sensory) Primary disability outcome: Fibromyalgia Impact Questionnaire Primary mood outcome: CES‐D Catatrophising outcome: none Pain Perception Scale (Sensory and Affective) Fibromyalgia Impact Questionnaire Depression: CES‐D Anxiety: Trait Sub‐scale STAI Pittsburgh Sleep Quality Index Health‐related Quality of Life Freiburg Mindfulness Inventory Physical symptoms: Giessen Complaint Questionnaire Ongoing therapies, medical visits and medication Medication diary Goal‐attainment scaling by interview |
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| Notes | Active relaxation control versus waiting list; analyses 7.1, 7.2, 7.3 2011 update search Yates quality scale: total quality = 31/35, design quality = 23/26, treatment quality = 8/9 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | “randomized in blocks by a computer algorithm” |
| Allocation concealment (selection bias) | Low risk | Patients and personnel blinded to treatment allocation |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition fully reported; no test for differences |
| Selective reporting (reporting bias) | Low risk | Fully reported |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessors blinded |