Table 4.
Descriptive statistics and between-group analyses for primary and secondary outcomes (intention to treat (ITT) approach).
| TAU M (SD) | TAU + NAT-FM M (SD) | TAU vs. NAT-FM | |||
|---|---|---|---|---|---|
| d | t (p) | B (95% CI) | |||
| Primary outcome | |||||
| FIQR (0–100) * | |||||
| Baseline | 73.21 (14.72) | 73.07 (13.79) | |||
| 6 weeks | 69.68 (13.36) | 58.78 (18.70) | 1.13 | −5.29 (<0.001) | −10.96 (−15.04 to −6.88) |
| Post−treatment | 69.18 (17.88) | 50.69 (18.05) | 1.83 | −8.16 (<0.001) | −18.07 (−22.43 to −13.72) |
| Secondary outcomes | |||||
| VAS PAIN (0–10) * | |||||
| Baseline | 7.80 (1.61) | 7.74 (1.52) | |||
| 6 weeks | 7.52 (1.59) | 6.78 (1.99) | 0.66 | −3.02 (0.003) | −0.77 (−1.28 to −0.27) |
| Post-treatment | 7.47 (1.79) | 5.60 (1.98) | 5.62 | −6.53 (<0.001) | −1.79 (−2.33 to −1.25) |
| VAS FATIGUE (0–10) * | |||||
| Baseline | 7.76 (1.91) | 7.61 (1.89) | |||
| 6 weeks | 7.32 (2.09) | 5.98 (2.10) | 0.77 | −3.10 (0.002) | −1.26 (−2.06 to −0.46) |
| Post-treatment | 7.08 (2.34) | 5.58 (2.00) | 0.93 | −3.87 (<0.001) | −1.53 (−2.31 to −0.75) |
| HADS-A (0–21) * | |||||
| Baseline | 13.13 (4.22) | 13.95 (3.80) | |||
| 6 weeks | 12.35 (4.07) | 11.03 (4.25) | 0.99 | −4.52 (<0.001) | −2.20 (−3.16 to −1.24) |
| Post-treatment | 12.68 (4.63) | 10.16 (4.19) | 1.59 | −7.08 (<0.001) | −3.51 (−4.48 to −2.53) |
| HADS-D (0–21) * | |||||
| Baseline | 11.49 (4.64) | 11.27 (3.71) | |||
| 6 weeks | 11.22 (5.02) | 9.66 (4.47) | 0.49 | −2.23 (0.027) | −1.10 (−2.07 to −0.13) |
| Post-treatment | 11.67 (5.18) | 8.18 (4.42) | 1.45 | −6.40 (<0.001) | −3.37 (−4.41 to −2.34) |
| SF-36 (0–100) * | |||||
| Baseline | 26.04 (18.11) | 27.03 (18.85) | |||
| 6 weeks | 28.24 (17.38) | 35.09 (20.47) | 0.53 | 2.41 (0.017) | 5.51 (1.00 to 10.02) |
| Post-treatment | 25.07 (15.86) | 43.42 (20.92) | 1.59 | 7.01 (<0.001) | 17.15 (12.34 to 21.96) |
| PANAS-PA (0–50) * | |||||
| Baseline | 12.26 (4.38) | 11.95 (5.79) | |||
| 6 weeks | 12.20 (4.30) | 12.81 (5.39) | 0.19 | 1.00 (0.319) | 0.79 (−0.77 to 2.35) |
| Post-treatment | 13.01 (4.03) | 14.11 (4.28) | 0.40 | 2.07 (0.039) | 1.68 (0.08 to 3.27) |
| PANAS-NA (0–50) * | |||||
| Baseline | 14.34 (5.81) | 13.84 (6.08) | |||
| 6 weeks | 13.94 (5.13) | 13.22 (4.83) | 0.13 | −0.37 (0.714) | −0.29 (−1.87 to 1.28) |
| Post-treatment | 14.95 (4.50) | 13.12 (4.24) | 0.28 | −1.38 (0.167) | −1.14 (−2.75 to 0.48) |
| RSES (10–40) * | |||||
| Baseline | 15.41 (3.57) | 16.03 (3.36) | |||
| 6 weeks | 15.48 (2.57) | 16.60 (2.70) | 0.37 | 1.23 (0.219) | 0.68 (−0.40 to 1.75) |
| Post-treatment | 16.25 (3.45) | 16.53 (2.25) | 0.03 | −0.24 (0.809) | −0.13 (−1.20 to 0.94) |
| PSS (0–16) * | |||||
| Baseline | 8.88 (2.15) | 8.93 (2.31) | |||
| 6 weeks | 8.81 (1.90) | 7.91 (1.87) | 0.43 | −1.88 (0.062) | −0.77 (−1.57 to 0.04) |
| Post-treatment | 8.88 (2.20) | 8 (1.87) | 0.37 | −1.66 (0.098) | −0.67 (−1.47 to 0.12) |
Note: Mean and SD are not adjusted. When the Benjamini–Hochberg correction was applied to correct for multiple comparisons, the following effects were not statistically significant: positive affect and negative affect schedule (PANAS) positive (p = 0.059). The number of participants varied across assessment periods due to dropouts (see flow chart). Significant values (p < 0.05) are shown in bold. * The baseline level of the variable is a significant covariate in the model. B, regression coefficients; CI, confidence interval; d, Cohen’s d as an effect size measure; ITT, intention-to-treat; NAT-FM; TAU, treatment-as-usual.