Changes in Secondary Outcomes by Study Group
| Intervention Patients (n=87) | Control Patients (n=85) | |||||
|---|---|---|---|---|---|---|
| Instrument | Mean (SE) [95% CI] | n | Mean (SE) [95% CI] | n | P Value, Time, Intervention vs Control | P Value, Group x Time Interaction |
| Note: MOS-10 denotes the physical functioning subscale from the RAND Medical Outcomes Study scale’s Short-Form Health Survey (scores range from 0 to 100; higher scores indicate better physical functioning). PHQ-15 denotes the somatic complaints module of the Patient Health Questionnaire (scores range from 0 to 30; higher scores indicate higher levels of somatic complaints in the preceding month). HAM-D denotes the 17-item Hamilton Depression Rating Scale (scores range from 0 to 48; higher scores indicate greater depression severity). HAM-A denotes the Hamilton Anxiety Rating Scale (scores range from 0 to 56; higher scores indicate greater anxiety severity). VAS denotes the visual analog scale used to assess medically unexplained symptoms (scores range from 0 to 100; higher scores represent a greater severity of symptoms). | ||||||
| CI = confidence interval; NS = not siginificant. | ||||||
| MOS-10 | ||||||
| Baseline | 63.28 (2.67) [58.00–68.55] | 87 | 61.41 (2.71) [56.07–66.75] | 85 | NS | NS |
| End of treatment | 72.19 (2.95) [66.37–78.01] | 63 | 69.71 (2.95) [63.89–75.54] | 63 | NS | .92 |
| Follow-up | 73.22 (3.36) [66.60–79.85] | 48 | 69.41 (3.45) [62.60–76.22] | 44 | NS | NS |
| PHQ-15 | ||||||
| Baseline | 14.17 (0.58) [13.03–15.32] | 87 | 13.98 (0.59) [12.82–15.13] | 85 | NS | NS |
| End of treatment | 9.32 (0.67) [8.01–10.64] | 63 | 11.50 (0.66) [10.19–12.81] | 64 | .01 | .03 |
| Follow-up | 9.11(0.59) [7.95–10.28] | 50 | 10.91 (0.62) [9.69–12.12] | 44 | .03 | NS |
| HAM-D | ||||||
| Baseline | 18.25 (0.64) [16.98–19.52] | 87 | 17.41 (0.65) [16.13–18.70] | 85 | NS | NS |
| End of treatment | 12.85 (0.85) [11.17–14.52] | 63 | 14.60 (0.84) [12.94–16.25] | 65 | .02 | .05 |
| Follow-up | 12.88 (0.88) [11.14–14.63] | 51 | 14.29 (0.93) [12.44–16.13] | 44 | .07 | NS |
| HAM-A | ||||||
| Baseline | 20.46 (0.75) [18.98–21.94] | 87 | 20.99 (0.76) [19.49–22.48] | 85 | NS | NS |
| End of treatment | 15.89 (1.08) [13.76–18.02] | 63 | 18.47 (1.07) [16.36–20.57] | 65 | NS | .19 |
| Follow-up | 14.85 (0.94) [12.99–16.70] | 51 | 17.58 (1.00) [15.61–19.54] | 44 | NS | NS |
| VAS | ||||||
| Baseline | 42.34 (1.94) [38.51–46.18] | 87 | 39.62 (1.97) [35.74–43.50] | 85 | NS | NS |
| End of treatment | 23.47 (1.77) [19.97–26.96] | 62 | 27.94 (1.75) [24.48–31.39] | 64 | .01 | .05 |
| Follow-up | 23.72 (1.67) [20.43–27.01] | 50 | 25.25 (1.77) [21.76–28.73] | 44 | .22 | NS |