Kashikar‐Zuck 2005.
Methods |
Study setting: North America (USA).Single centre, paediatric rheumatology non‐university clinic, outpatient based Study design: Cross‐over Duration therapy: 8 weeks Follow‐up: None Analysis: T‐ tests for pre‐treatment differences, repeated measures ANOVA 2 (baseline versus time 2) x 2 (CBT versus control), within‐subjects effects, difference between 2 conditions based upon sequence of treatment delivery by analysis with proc mixed model, effect sizes (time 1 to time 2, time 2 to time 3, time 1 to time 3) |
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Participants |
Patients: Total group: 14 patients each in both groups; 100% female, 93% white, mean age 15.8 years; duration of symptoms not reported Inclusion: Age between 13 and 17 years, Juvenile Primary Fibromyalgia criteria, stabilization on medication for at least 4 weeks prior to enrolment, VAS pain 0‐10 score at least 3 an a 10 cm VAS, functional disability score greater than 7 (mild disability) Exclusion: Co‐morbid rheumatic disease, developmental delay or impairment, major depressive disorder |
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Interventions |
Treatment Group: CBT, single, group and with parents: Relaxation, distraction, activity pacing, cognitive and problem‐solving techniques (1x1.5h/week), total: 12h Control Group: Active control, single: Self‐monitoring with diary Co‐medication allowed: Yes (standard medical care) Other Co‐therapies: Not reported |
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Outcomes |
Primary Outcomes Self reported pain: VAS pain 0‐10 Self reported negative mood: Children’s Depression Inventory (CDI) T score Self reported disability: Functional Disability Inventory (FDI) 0‐60 Acceptability: Total dropout rate Secondary Outcomes Self reported self efficacy pain: Pain Coping Questionnaire (PCQ) 1‐5 Self reported fatigue: Not assessed Self reported sleep problems: Not assessed Self reported disease‐specific health‐related quality of life: Not assessed |
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Notes | 1. Reasons for dropout: ‐ Treatment Group: 1x due to distance ‐ Control Group:1x no contact, 1x family issues 2. Attendance rates: 90% of all participants attended all sessions 3.Responder analysis: None 4. Funding sources and declaration of interest of the primary researchers: Supported by grants of the Cincinnati Children's Hospital Reserach Foundation and National Institutes Helath Grant 1P60AR47784‐01) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated pseudo‐random number list |
Allocation concealment (selection bias) | Low risk | 1:1 allocation ratio for the subjects as a single block was used. An assistant who was blinded enrolled the subject and opened a sealed envelope with the subject's study number |
Incomplete outcome data (attrition bias) All outcomes | High risk | No intention‐to‐treat analysis |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Blinding of outcome assessor | Low risk | An assistant and a rheumatologist who were blinded |