Greco 2004.
Methods | RCT; 3 arms; assessed pre‐treatment, post‐treatment, 6/9 months | |
Participants | End of treatment n = 80 Start of treatment n = 92 Sex: 87 F, 5 M (at start of treatment) Mean age = 47.3 (SD 10.4) Source = volunteers Diagnosis = SLE Mean years of pain = 11 |
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Interventions | "CBT with biofeedback" "Symptom monitoring and support" "Treatment as usual" |
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Outcomes |
Primary pain outcome: AIMS2 pain 0 to 10 Primary disability outcome: SF36 physical function (reversed) Primary mood outcome: CES‐D Depression Catastrophising outcome: perceived stress Arthritis Impact Measurement Scale (AIMS) 2: pain Multidimensional Pain Inventory: interference Center for Epidemiologic Studies Depression Scale (CES‐D) Arthritis Self‐Efficacy Perceived stress Short Form 36 physical function Fatigue severity Global self assessment Disease activity systemic lupus activity measure‐revised (SLAM‐R) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) |
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Notes | CBT versus active, post‐treatment and follow‐up: analyses 1.1, 1.2, 1.3, 2.1, 2.2, 2.3 CBT versus TAU, post‐treatment and follow‐up: analyses 3.1, 3.2, 3.3, 4.1, 4.2, 4.3 Yates quality scale: total quality = 25/35, design quality = 20/26, treatment quality = 5/9 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “assigned randomly, based on a software‐generated randomization plan” |
Allocation concealment (selection bias) | High risk | Not reported, but equal credibility of treatments rated by participants |
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 | Rheumatologist and researcher assessors masked to treatment assignment |