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. 2013 Sep 10;2013(9):CD009796. doi: 10.1002/14651858.CD009796.pub2

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)
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
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
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
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)
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