Mean (95% CI) scores and treatment effects (differences post-treatment and 12 months) and overall p values estimated with mixed models linear repeated measures analysis*
| VTP group | Control group | Treatment effect (95% CI) | p Value | Effect size§ | |
|---|---|---|---|---|---|
| Primary outcome | |||||
| Psychological distress (GHQ-20) (0–60, 0=no distress)‡ | 0.002 | ||||
| Baseline | 19.9 (17.8 to 22.1) | 19.8 (17.5 to 22.0) | |||
| Post-treatment | 15.7 (13.5 to 17.9) | 20.4 (17.4 to 23.4) | −4.7 (−7.6 to −1.8) | 0.73 | |
| 12 months | 14.5 (12.8 to 16.2) | 18.4 (15.7 to 21.2) | −3.7 (−6.3 to −1.1) | 0.58 | |
| Co-primary outcomes | |||||
| Self-efficacy pain (10–100, 100=high SE)† | 0.001 | ||||
| Baseline | 55.4 (50.3 to 60.6) | 60.9 (55.7 to 66.4) | |||
| Post-treatment | 65.9 (61.7 to 70.0) | 61.0 (55.3 to 66.7) | 8.2 (2.1 to 14.2) | 0.54 | |
| 12 months | 67.8 (62.4 to 73.3) | 61.5 (55.8 to 67.3) | 9.1 (3.4 to 14.8) | 0.59 | |
| Self-efficacy symptoms (10–100, 100=high self-efficacy)† | <0.001 | ||||
| Baseline | 64.2 (59.8 to 68.6) | 66.6 (61.2 to 72.1) | |||
| Post-treatment | 74.3 (70.9 to 77.7) | 68.5 (62.7 to 64.4) | 8.8 (3.0 to 14.6) | 0.62 | |
| 12 months | 73.3 (68.9 to 77.6) | 62.8 (56.4 to 69.1) | 13.1 (6.7 to 19.3) | 0.92 | |
| EAC processing (1–4, 4=high processing)† | <0.001 | ||||
| Baseline | 2.7 (2.5 to 3.0) | 2.8 (2.6 to 3.1) | |||
| Post-treatment | 3.2 (3.0 to 3.4) | 2.9 (2.7 to 3.1) | 0.4 (0.29 to 0.6) | 0.57 | |
| 12 months | 3.1 (2.9 to 3.3) | 2.9 (2.6 to 3.1) | 0.3 (0.02 to 0.5) | 0.43 | |
| EAC expression (1–4, 4=high expression)† | 0.191 | ||||
| Baseline | 2.6 (2.4 to 2.9) | 2.6 (2.4 to 2.8) | |||
| Post-treatment | 3.0 (2.8 to 3.2) | 2.8 (2.6 to 3.0) | 0.2 (−0.02 to 0.4) | 0.29 | |
| 12 months | 2.9 (2.7 to 3.1) | 2.8 (2.6 to 3.1) | 0.04 (−0.2 to 0.3) | 0.06 | |
| Secondary outcomes | |||||
| Pain (0–10, 0=no pain)‡ | 0.064 | ||||
| Baseline | 4.7 (4.1 to 5.3) | 4.6 (3.9 to 5.3) | |||
| Post-treatment | 4.6 (4.1 to 5.2) | 4.9 (4.1 to 5.7) | −0.4 (−0.97 to 0.22) | 0.21 | |
| 12 months | 3.9 (3.3 to 4.5) | 4.5 (3.8 to 5.1) | −0.6 (−1.28 to 0.02) | 0.32 | |
| Fatigue (0–10, 0=no fatigue)‡ | 0.002 | ||||
| Baseline | 5.2 (4.5 to 5.9) | 4.9 (4.1 to 5.7) | |||
| Post-treatment | 4.8 (3.9 to 5.7) | 5.2 (4.4 to 6.1) | −0.8 (−1.5 to −0.2) | 0.36 | |
| 12 months | 4.1 (3.3 to 5.0) | 4.9 (4.1 to 5.7) | −1.1 (−1.8 to −0.4) | 0,50 | |
| PGA (0–10, 0=no activity)‡ | 0.069 | ||||
| Baseline | 4.6 (4.0 to 5.1) | 4.5 (3.9 to 5.2) | |||
| Post-treatment | 4.5 (3.9 to 5.0) | 4.8 (4.0 to 5.5) | −0.3 (−0.89 to 0.23) | 0.18 | |
| 12 months | 3.8 (3.2 to 4.4) | 4.5 (3.9 to 5.2) | −0.7 (−1.38 to −0.05) | 0.41 | |
| Self-care ability (0–10, 10=very good)‡ | <0.001 | ||||
| Baseline | 7.0 (6.4 to 7.6) | 6.9 (6.3 to 7.4) | |||
| Post-treatment | 7.7 (7.1 to 8.3) | 6.4 (5.8 to 7.0) | 1.2 (0.7 to 1.7) | 0.71 | |
| 12 months | 7.7 (7.1 to 8.3) | 6.6 (6.0 to 7.2) | 1.0 (0.5 to 1.6) | 0.59 | |
| Overall well-being (0–10, 10=very good)‡ | <0.001 | ||||
| Baseline | 6.5 (6.0 to 7.0) | 6.3 (5.9 to 6.8) | |||
| Post-treatment | 7.0 (6.5 to 7.5) | 6.2 (5.6 to 6.7) | 0.8 (0.2 to 1.3) | 0.57 | |
| 12 months | 7.4 (7.0 to 7.9) | 6.7 (6.2 to 7.2) | 0.6 (0.1 to 1.2) | 0.43 | |
↵* Adjustment for the baseline mean value as well as for gender, age, disease duration, education and civil status.
↵† Measured once at baseline and follow-ups.
↵‡ Five repeated measures at baseline and follow-ups.
↵§ Adjusted between-group difference divided by the pooled SD of the baseline scores (<0.2, trivial; 0.2–0.49, small; 0.5–0.79, moderate; ≥80, large).
EAC, emotional approach coping; GHQ, General Health Questionnaire; PGA, patient global assessment of disease activity; VTP, Vitality Training Programme.