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. 2020 Aug 14;2020(8):CD007407. doi: 10.1002/14651858.CD007407.pub4

Barsky 2010.

Study characteristics
Methods RCT; 3 arms; assessed pretreatment, post‐treatment, 6‐, and 12‐months
Participants Post‐treatment n = 133 at 6 months
Start of treatment n = 168
Sex: 146 F, 22 M
Mean age = 53.4 (SD 12.9)
Source = hospital, public advertisements
Diagnosis = rheumatoid arthritis
Mean years of pain = 13.5 (SD 11.5)
Interventions CBT ‐ Cognitive behavioural therapy
RR ‐ Relaxation response training
AE ‐ Arthritis eduction
Outcomes Primary pain outcome: Rheumatoid Arthritis Symptom Questionnaire (RASQ) VAS 1‐10
Primary disability outcome: Arthritis Impact Measurement Scale (AIMS‐2) Mobility
Primary distress outcome: Rand Mental Health Inventory (Depression)
Rheumatoid Arthritis Symptom Questionnaire (RASQ)
Arthritis Impact Measurement Scale (AIMS‐2)
Erythrocyte sedimentation rate (ESR)
Standardised physician ratings of joint swelling to index disease severity and activity
Medications
Rand Mental Health Inventory
Notes No data provided
Funding statement: Supported by research grant R01 AR 4701401 from the National Institute of Arthritis & Musculoskeletal and Skin Diseases.
Conflict of interests: None described.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Once five subjects were accrued, this group was randomly assigned by computer to one of the three treatment modalities"
Allocation concealment (selection bias) High risk No description of allocation. However, this statement was included in the text suggesting that the latter participants had unequal chance of being randomised to treatment conditions. "However, after accruing 127 patients, unequal numbers of patients across the treatment arms led us to an unbalanced randomization for the remaining 41 patients in order to restore balance."
Blinding of outcome assessment (detection bias)
All outcomes Low risk "Data were gathered by research assistants blind to treatment modality, and the therapists had no role in data collection."
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Attrition > 10%. LOCF analyses used.
Selective reporting (reporting bias) Unclear risk Protocol registered (NCT00056667). Some questionnaires registered in protocol not included in manuscript.
Treatment expectations Unclear risk Not assessed.