Outcomes by treatment arm at 12 months (intention-to-treat analysis)
Characteristic | Randomised groups | |
tCBT (n=500) | Usual care (n=496) | |
Primary outcome | N (%) | N (%) |
Chronic widespread pain | ||
No | 315 (82.0) | 364 (82.5) |
Yes | 69 (18.0) | 77 (17.5) |
Secondary outcome | ||
Global impression of change | ||
Very much better | 24 (6.5) | 15 (3.5) |
Much better | 88 (23.7) | 59 (13.8) |
A little better | 90 (24.3) | 84 (19.6) |
No change | 83 (22.4) | 126 (29.4) |
A little worse | 65 (17.5) | 119 (27.7) |
Much worse | 18 (4.9) | 23 (5.4) |
Very much worse | 3 (0.8) | 3 (0.7) |
Pain reported | ||
No | 79 (20.6) | 68 (15.4) |
Yes | 305 (79.4) | 373 (84.6) |
CWP risk profile | ||
Somatic symptoms score | ||
0 | 210 (56.5) | 228 (52.8) |
1 | 103 (27.7) | 123 (28.5) |
2–5 | 59 (15.9) | 81 (18.8) |
Illness behaviour score, mean (SD) (n)* | 8.21 (4.04) (371) | 8.96 (4.19) (431) |
Sleep problems score, mean (SD) (n) | 8.20 (4.89) (373) | 9.20 (5.16) (432) |
Psychological distress (GHQ score) | ||
0 | 201 (54.5) | 202 (46.8) |
1 | 59 (16.0) | 54 (12.5) |
2–5 | 68 (18.4) | 113 (26.2) |
6–12 | 41 (11.1) | 63 (14.6) |
Mean (SD) (n) | Mean (SD) (n) | |
Chalder Fatigue Score | 12.6 (4.5) (370) | 13.6 (4.4) (433) |
Median (IQR) (n) | Median (IQR) (n) | |
Quality of Life (EQ-5D utility score) | 0.74 (0.66–0.84) (371) | 0.74 (0.65–0.82) (435) |
ICECAP-A | 0.91 (0.82–0.97) (368) | 0.89 (0.78–0.95) (429) |
Fibromyalgia research criteria | ||
WPI | 2 (1–4) (366) | 2 (1–4) (427) |
SSS | 3 (2–5) (369) | 4 (2–5) (431) |
*The number of persons for whom a scale score could be calculated.
EQ-5D, EuroQol Questionnaire-five dimensions; GHQ, General Health Questionnaire; ICECAP-A, ICEpop CAPability measure for Adults; SSS, Symptom Severity Scale; tCBT, telephone-delivered cognitive–behavioural therapy; WPI, Widespread Pain Index.