| Methods |
Design: three group parallel trial
Purpose: examine the effect of cognitive therapy on fibromyalgia |
| Participants |
Patients: out‐patients with fibromyalgia
Baseline comparability: yes |
| Interventions |
Placebo: sessions of group discussions on pain experience + educational programme on pain
Untreated: no sessions
Experimental: sessions of cognitive therapy + educational programme on pain
(Co‐intervention: NS) |
| Outcomes |
Pain (McGill pain questionnaire)
Pain: coping, control, behaviour
% positive responders
Relaxation
Tension
Catastrophing
Activity
Obsessive‐compulsive
Fear
Depression |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/cognitive therapy) |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (not naturally positive continuous outcomes e.g. change) |
| Trial size > 49? |
Low risk |
N = 79 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation not clearly concealed |
