| Methods |
Design: three group parallel trial
Purpose: examine the effect of cognitive‐behavioural therapy on depression associated with rheumatoid arthritis |
| Participants |
Patients: in‐patients with rheumatoid arthritis
Baseline comparability: no (age) |
| Interventions |
Placebo: general patient education program
Untreated: no program
Experimental: cognitive behavioural program (10 weekly visits)
(Co‐intervention: standard medical care and anti‐depressive medication) |
| Outcomes |
Center for epidemiological studies‐depression scale (CES‐D)
Hamilton rating scale for depression
Geriatric depression scale
Symptom checklist 90‐R
Coping strategies questionnaire
Daily stress inventory
Hassles scale
State‐trait anxiety inventory
Arthritis helplessness index
Arthritis self‐efficiency scale
Arthritis impact measurement scale 2
multidimensional assessment of fatigue
Pain (VAS)
McGill pain questionnaire
Rapid assessment of disease activity in rheumatology
Erythrocyte sedimentation rate |
| Notes |
Standard deviation for mean CES‐D scores not reported. Standard deviation taken from another study (Kozora 2006): 7.5. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/cognitive behavioural therapy) |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
High risk |
No protocol available. Standard deviation for mean CES‐D scores not reported. Standard deviation taken from another study (Kozora 2006): 7.5. |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
High risk |
N = 27 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
