Table 3.
Summary statistics and results from the mixed model analysis of the secondary outcomes
| Secondary outcomes | Control group (n=189) | Intervention group (n=187) | Minimally adjusted mixed model analysis (95% CI)* | P value | Effect size (minimally adjusted mixed model) (95% CI) | Adjusted mixed model analysis (95% CI)† | P value | Effect size (adjusted mixed model) (95% CI) | |
|---|---|---|---|---|---|---|---|---|---|
| Patient health questionnaire anxiety and depression scale | |||||||||
| Baseline | 26 (7.5) | 27 (7.8) | — | 0.67 | — | — | — | — | |
| 12 months | 18 (9.1) | 15 (10) | −2.86 (−4.99 to −0.73) | 0.01 | 0.30 (0.08 to 0.52) | −2.60 (−4.71 to −0.49) | 0.02 | 0.29 (0.06 to 0.53) | |
| Patient health questionnaire 9-item depression scale | |||||||||
| Baseline | 14 (5.2) | 15 (5.3) | — | 0.35 | — | — | — | — | |
| Six months | 10 (5.7) | 9.1 (5.7) | −1.31 (−2.54 to −0.09) | 0.04 | 0.26 (0.02 to 0.50) | −1.22 (−2.42 to −0.02) | 0.05 | 0.24 (0.00 to 0.47) | |
| 12 months | 9.5 (5.3) | 8.1 (5.8) | −1.31 (−2.26 to −0.36) | <0.01 | 0.20 (0.06 to 0.34) | −1.24 (−2.18 to −0.31) | 0.01 | 0.19 (0.05 to 0.35) | |
| Seven item generalised anxiety disorder scale | |||||||||
| Baseline | 12 (4.5) | 12 (4.3) | — | 0.97 | — | — | — | — | |
| Six months | 8.7 (4.9) | 8 (5.1) | −0.91 (−1.95 to 0.13) | 0.09 | 0.15 (−0.02 to 0.32) | −0.84 (−1.87 to 0.18) | 0.11 | 0.14 (−0.03 to 0.32) | |
| 12 months | 8.2 (4.5) | 7.1 (4.7) | −1.36 (−2.48 to −0.23) | 0.02 | 0.34 (0.06 to 0.62) | −1.22 (−2.30 to −0.13) | 0.03 | 0.30 (0.03 to 0.57) | |
| Somatic symptom disorder-B criteria scale | |||||||||
| Baseline | 22 (11) | 22 (12) | — | 0.97 | — | — | — | — | |
| Six months | 19 (12) | 18 (12) | −2.24 (−4.17 to −0.31) | 0.02 | 0.24 (0.03 to 0.45) | −2.21 (−4.12 to −0.31) | 0.02 | 0.24 (0.03 to 0.44) | |
| 12 months | 20 (11) | 17 (11) | −3.56 (−5.76 to −1.36) | <0.01 | 0.39 (0.15 to 0.63) | −3.39 (−5.63 to −1.15) | <0.01 | 0.39 (0.13 to 0.65) | |
| 12 item short form survey | |||||||||
| Physical component score§: | |||||||||
| Baseline | 42 (10) | 43 (11) | — | 0.35 | — | — | — | — | |
| Six months | 43 (11) | 45 (11) | 1.26 (−0.67 to 3.20) | 0.20 | 0.12 (−0.06 to 0.30) | 1.13 (−0.83 to 3.09)‡ | 0.26 | 0.12 (−0.08 to 0.32) | |
| 12 months | 43 (11) | 46 (11) | 1.85 (−0.05 to 3.75) | 0.06 | 0.13 (0.00 to 0.27) | 1.51 (−0.37 to 3.40)‡ | 0.12 | 0.11 (−0.03 to 0.26) | |
| Mental component score: | |||||||||
| Baseline | 30 (7.7) | 29 (8.2) | — | 0.36 | — | — | — | — | |
| Six months | 38 (11) | 40 (11) | 2.47 (0.23 to 4.71) | 0.03 | 0.18 (0.02 to 0.34) | 2.42 (0.19 to 4.65) | 0.03 | 0.18 (0.02 to 0.35) | |
| 12 months | 39 (11) | 41 (12) | 2.28 (−0.20 to 4.76) | 0.07 | 0.14 (−0.01 to 0.30) | 2.29 (−0.15 to 4.73) | 0.07 | 0.14 (−0.01 to 0.29) | |
| Recovery assessment scale | |||||||||
| Personal confidence and hope: | |||||||||
| Baseline | 10 (3.4) | 9.9 (3.7) | — | 0.69 | — | — | — | — | |
| Six months‡ | 12 (4.4) | 13 (4.1) | 0.54 (−0.22 to 1.29) | 0.16 | 0.12 (−0.05 to 0.28) | 0.54 (−0.23 to 1.31) | 0.17 | 0.12 (−0.05 to 0.29) | |
| 12 months‡ | 12 (3.9) | 13 (4.2) | 0.50 (−0.28 to 1.27) | 0.21 | 0.13 (−0.07 to 0.32) | 0.46 (−0.31 to 1.28) | 0.24 | 0.12 (−0.08 to 0.31) | |
| Goal and success orientation: | |||||||||
| Baseline | 5.3 (2) | 5.4 (2) | — | 0.78 | — | — | — | — | |
| Six months‡ | 5.4 (2.2) | 5.8 (2.2) | 0.23 (−0.20 to 0.67) | 0.28 | 0.14 (−0.12 to 0.39) | 0.14 (−0.29 to 0.57) | 0.51 | 0.09 (−0.18 to 0.35) | |
| 12 months‡ | 5 (2.2) | 5.4 (1.9) | 0.16 (−0.22 to 0.53) | 0.40 | 0.09 (−0.13 to 0.31) | 0.11 (−0.26 to 0.49) | 0.55 | 0.07 (−0.15 to 0.29) | |
| Willingness to ask others for help: | |||||||||
| Baseline | 7.1 (2.8) | 7 (2.9) | — | 0.77 | — | — | — | — | |
| Six months‡ | 8.4 (3.6) | 8.8 (3.3) | 0.47 (−0.16 to 1.09) | 0.14 | 0.09 (−0.03 to 0.22) | 0.53 (−0.10 to 1.15) | 0.10 | 0.11 (−0.02 to 0.23) | |
| 12 months‡ | 8.4 (3.1) | 8.8 (3.1) | 0.28 (−0.32 to 0.89) | 0.36 | 0.07 (−0.09 to 0.23) | 0.28 (−0.34 to 0.89) | 0.37 | 0.07 (−0.09 to 0.24) | |
| Reliance on others: | |||||||||
| Baseline | 5.9 (2) | 6 (1.9) | — | 0.79 | — | — | — | — | |
| Six months‡ | 6.7 (1.8) | 6.7 (1.8) | 0.08 (−0.27 to 0.44) | 0.64 | 0.05 (−0.15 to 0.25) | 0.11 (−0.25 to 0.46) | 0.56 | 0.06 (−0.14 to 0.26) | |
| 12 months‡ | 6.5 (1.8) | 6.5 (1.9) | 0.01 (−0.32 to 0.34) | 0.97 | 0.00 (−0.15 to 0.16) | 0.01 (−0.32 to 0.33) | 0.96 | 0.00 (−0.14 to 0.14) | |
| No domination by symptoms: | |||||||||
| Baseline | 2.5 (1.8) | 2.6 (1.8) | — | 0.69 | — | — | — | — | |
| Six months‡ | 3.8 (2.5) | 4.1 (2.5) | 0.48 (−0.11 to 1.07) | 0.11 | 0.19 (−0.05 to 0.42) | 0.38 (−0.21 to 0.96) | 0.20 | 0.15 (−0.08 to 0.39) | |
| 12 months‡ | 4.1 (2.1) | 4.5 (2.3) | 0.51 (0.03 to 0.99) | 0.04 | 0.16 (0.01 to 0.30) | 0.46 (−0.02 to 0.93) | 0.06 | 0.16 (−0.01 to 0.32) | |
| Patient assessment of chronic illness care-short form | |||||||||
| Baseline | 2.6 (0.85) | 2.4 (0.85) | — | 0.03 | — | — | — | — | |
| Six months | 2.4 (0.81) | 2.8 (0.9) | 0.34 (0.14 to 0.53) | <0.01 | 0.39 (0.17 to 0.61) | 0.34 (0.15 to 0.53) | <0.01 | 0.38 (0.17 to 0.60) | |
| 12 months | 2.4 (0.85) | 2.5 (0.94 | 0.13 (−0.07 to 0.32) | 0.19 | 0.13 (−0.07 to 0.32) | 0.13 (−0.06 to 0.31) | 0.18 | 0.12 (−0.05 to 0.29) | |
Data are mean (SD), unless otherwise stated, effect size measured with Cohen’s d.
*
Mixed effect linear regression model, minimally adjusted for the respective baseline score and centre for intervention v control.
†
Mixed effect linear regression models adjusted for the respective baseline score, age, gender, history of depression or anxiety, 12 item short form physical component score, chronic medical disease, and no. of days between baseline assessment and randomisation, for intervention v control.
‡
The German version was used.
§
Mixed effect linear regression model adjusted for the respective baseline score, age, gender, history of depression or anxiety, chronic medical disease, no. of days between baseline assessment and randomisation.