1. Background
2. Objectives
3. Methods
3.1. Study Design
3.2. Study Population
3.3. Sampling Method
3.4. Sampling Process
3.5. Ethics Approval
3.6. Intervention Protocols
3.7. Outcome Measures
3.8. Study Stool
3.9. Method of Measurement
3.10. Blinding
3.11. Statistical Analysis
4. Results
4.1. Participant Flow
4.2. Baseline Data
| Variables | Sex | Education | |||
|---|---|---|---|---|---|
| Female | Male | Less than Diploma | Diploma | Bachelor | |
| Control | 11 (73.3) | 4 (26.7) | 12 (80) | 3 (20) | 0 |
| Intervention | 6 (40.0) | 9 (60.0) | 6 (40) | 7 (46.7) | 2 (13.3) |
| P-value | 0.139 | 0.061 | |||
a Values are expressed as No. (%).
4.3. Numbers Analyzed
4.4. Outcomes and Estimation
4.4.1. Wisconsin Card Sorting Test
| Test; Time | Control Group | Intervention Group | Between Group P-Value | Time | Within-Group P-Values | |
|---|---|---|---|---|---|---|
| Control Group | Intervention Group | |||||
| Wisconsin test | ||||||
| Changes in number of categories | ||||||
| Baseline | 2.60 ± 1.40 | 1.73 ± 1.53 | 0.118 | 4 vs baseline | 1 | 0.007 |
| 4 wk | 2.73 ± 1.48 | 2.33 ± 1.87 | 0.523 | 8 vs baseline | 0.028 | 0.827 |
| 8 wk | 3.73 ± 1.33 | 2.27 ± 2.34 | 0.044 | 12 vs baseline | 0.016 | 0.217 |
| 12 wk | 3.66 ± 1.23 | 2.26 ± 2.05 | 0.033 | Trend | 0.736 | 0.949 |
| P-value | 0.0003 | - | - | - | - | |
| Changes in perseveration errors | ||||||
| Baseline | 22.67 ± 15.98 | 16.40 ± 5.97 | 0.166 | 4 vs baseline | 0.384 | 0.002 |
| 4 wk | 22.47 ± 15.51 | 13.07 ± 7.72 | 0.045 | 8 vs baseline | 0.051 | 0.008 |
| 8 wk | 19.27 ± 13.50 | 10.87 ± 5.87 | 0.036 | 12 vs baseline | 0.019 | 0.0004 |
| 12 wk | 17.46 ± 12.68 | 9.00 ± 4.67 | 0.026 | Trend | 0.614 | < 0.001 |
| P-value | < 0.001 | - | - | - | - | |
| Digit span test | ||||||
| Changes in forward digits | ||||||
| Baseline | 3.87 ± 1.45 | 6.00 ± 1.60 | 0.001 | 4 vs baseline | 0.546 | 0.005 |
| 4 wk | 3.73 ± 1.48 | 7.53 ± 2.06 | 0.00005 | 8 vs baseline | 0.67 | 0.000005 |
| 8 wk | 3.80 ± 1.56 | 10.33 ± 1.58 | 0.00001 | 12 vs baseline | 0.719 | 0.068 |
| 12 wk | 3.80 ± 1.32 | 7.06 ± 2.18 | 0.000009 | Trend | 0.99 | 0.001 |
| P-value | < 0.000 | - | - | - | - | |
| Changes in backward digits | ||||||
| Baseline | 2.33 ± 1.17 | 3.47 ± 1.35 | 0.021 | 4 vs baseline | 1 | 0.026 |
| 4 wk | 2.33 ± 1.17 | 4.47 ± 1.06 | 0.000003 | 8 vs baseline | 0.719 | 0.016 |
| 8 wk | 2.27 ± 1.48 | 4.60 ± 1.35 | 0.00004 | 12 vs baseline | 0.719 | 0.61 |
| 12 wk | 2.26 ± 1.48 | 3.60 ± 1.18 | 0.008 | Trend | 0.989 | 0.058 |
| P-value | < 0.001 | - | - | - | - | |
| Stroop test | ||||||
| Changes in congruent correct | ||||||
| Baseline | 29.01 ± 11.42 | 28.27 ± 10.77 | 1 | 4 vs baseline | 0.095 | 0.004 |
| 4 wk | 28.73 ± 10.57 | 32.33 ± 9.88 | 0.344 | 8 vs baseline | 0.006 | 0.081 |
| 8 wk | 27.13 ± 10.59 | 32.67 ± 10.88 | 0.17 | 12 vs baseline | 0.003 | 0.003 |
| 12 wk | 25.86 ± 9.64 | 36.06 ± 9.06 | 0.006 | Trend | 0.115 | 0.062 |
| P-value | 0.007 | - | - | - | - | |
| Changes in incongruent correct | ||||||
| Baseline | 17.96 ± 10.48 | 18.13 ± 11.23 | 1 | 4 vs baseline | 0.792 | 0.015 |
| 4 wk | 18.20 ± 10.80 | 20.60 ± 10.92 | 0.55 | 8 vs baseline | 0.873 | 0.006 |
| 8 wk | 19.33 ± 11.17 | 23.53 ± 12.91 | 0.349 | 12 vs baseline | 0.827 | 0.004 |
| 12 wk | 20.53 ± 11.14 | 29.26 ± 12.00 | 0.048 | Trend | 0.977 | 0.021 |
| P-value | 0.001 | - | - | - | - | |
| Changes in congruent errors | ||||||
| Baseline | 6.73 ± 4.86 | 5.20 ± 3.68 | 0.339 | 4 vs baseline | 0.582 | 0.09 |
| 4 wk | 6.60 ± 4.20 | 3.60 ± 3.01 | 0.033 | 8 vs baseline | 0.597 | 0.017 |
| 8 wk | 7.00 ± 5.61 | 2.40 ± 3.56 | 0.01 | 12 vs baseline | 0.128 | 0.002 |
| 12 wk | 8.00 ± 6.38 | 1.93 ± 2.49 | 0.003 | Trend | 0.772 | 0.031 |
| P-value | 0.227 | - | - | - | - | |
| Changes in incongruent error | ||||||
| Baseline | 18.73 ± 9.00 | 9.93 ± 9.42 | 0.014 | 4 vs baseline | 0.217 | 0.007 |
| 4 wk | 18.47 ± 8.46 | 7.53 ± 6.64 | 0.001 | 8 vs baseline | 0.554 | 0.001 |
| 8 wk | 19.13 ± 9.47 | 4.53 ± 4.56 | 0.00003 | 12 vs baseline | 0.565 | 0.003 |
| 12 wk | 19.26 ± 9.60 | 3.80 ± 4.55 | 0.00002 | Trend | 0.968 | 0.008 |
| P-value | < 0.001 | - | - | - | - | |
| Changes in congruent reaction time | ||||||
| Baseline | 1465.93 ± 165.66 | 1470.20 ± 96.66 | 0.932 | 4 vs baseline | 0.953 | 0.194 |
| 4 wk | 1465.87 ± 165.68 | 1439.87 ± 95.77 | 0.603 | 8 vs baseline | 0.135 | 0.01 |
| 8 wk | 1549.60 ± 119.32 | 1377.40 ± 112.06 | 0.0001 | 12 vs baseline | 0.864 | 0.001 |
| 12 wk | 1444.33 ± 400.63 | 1342.86 ± 125.86 | 0.357 | Trend | 0.508 | 0.066 |
| P-value | 0.032 | - | - | - | - | |
| Changes in incongruent reaction time | ||||||
| Baseline | 1471.71 ± 346.19 | 1645.00 ± 121.05 | 0.078 | 4 vs baseline | 0.542 | 0.2 |
| 4 wk | 1467.13 ± 340.56 | 1595.13 ± 123.74 | 0.182 | 8 vs baseline | 0.376 | 0.0001 |
| 8 wk | 1568.27 ± 222.19 | 1491.13 ± 118.42 | 0.25 | 12 vs baseline | 0.345 | 0.00002 |
| 12 wk | 1575.73 ± 231.53 | 1438.00 ± 119.60 | 0.05 | Trend | 0.476 | 0.003 |
| P-value | 0.604 | - | - | - | - | |
| PNASS test | ||||||
| Changes in positive symptoms | ||||||
| Baseline | 10.47 ± 8.39 | 10.13 ± 1.72 | 0.002 | 12 vs baseline | 0.357 | 0.284 |
| 12 wk | 9.00 ± 8.05 | 9.76 ± 1.79 | 0.001 | - | - | - |
| P-value | 0.552 | - | - | - | - | |
| Changes in negative symptoms | ||||||
| Baseline | 15.53 ± 7.04 | 14.93 ± 4.59 | 0.784 | 12 vs baseline | 0.546 | 0.08 |
| 12 wk | 15.66 ± 7.51 | 12.80 ± 4.24 | 0.209 | - | - | - |
| P-value | 0.266 | - | - | - | - | |
| Changes in overall symptoms | ||||||
| Baseline | 51.33 ± 17.99 | 52.07 ± 10.36 | 0.006 | 12 vs baseline | 0.136 | 0.241 |
| 12 wk | 48.00 ± 18.08 | 49.83 ± 10.26 | 0.003 | - | - | - |
| P-value | 0.605 | - | - | - | - | |
| Ray memory test | ||||||
| Changes in immediate auditory | ||||||
| Baseline | 2.26 ± 0.70 | 3.20 ± 0.86 | 0.003 | 4 vs baseline | 0.061 | 0.0028 |
| 4 wk | 3.53 ± 1.18 | 4.60 ± 1.18 | 0.02 | 8 vs baseline | 0.221 | 0.0003 |
| 8 wk | 3.93 ± 1.38 | 4.93 ± 1.57 | 0.076 | 12 vs baseline | 0.123 | < 0.001 |
| 12 wk | 4.26 ± 1.48 | 6.33 ± 2.12 | 0.005 | Trend | 0.344 | 0.017 |
| P-value | 0.001 | - | - | - | - | |
| Changes in delayed auditory | ||||||
| Baseline | 3.20 ± 1.78 | 4.06 ± 2.28 | 0.256 | 4 vs baseline | 0.195 | 0.264 |
| 4 wk | 4.13 ± 1.92 | 5.53 ± 2.13 | 0.069 | 8 vs baseline | 0.071 | 0.004 |
| 8 wk | 9 4.73 ± 2.25 | 7.00 ± 2.50 | 0.015 | 12 vs baseline | 0.098 | 0.013 |
| 12 wk | 4.46 ± 2.16 | 6.33 ± 2.31 | 0.031 | Trend | 0.741 | 0.236 |
| P-value | 0.118 | - | - | - | - | |
| Changes in immediate visual | ||||||
| Baseline | 19.33 ± 4.62 | 21.56 ± 4.80 | 0.205 | 4 vs baseline | 0.063 | 0.2 |
| 4 wk | 19.90 ± 4.75 | 23.90 ± 4.98 | 0.033 | 8 vs baseline | 0.171 | 0.001 |
| 8 wk | 20.06 ± 4.75 | 25.66 ± 5.19 | 0.005 | 12 vs baseline | 0.098 | 0.007 |
| 12 wk | 17.66 ± 5.28 | 26.60 ± 5.20 | < 0.001 | Trend | 0.341 | 0.351 |
| P-value | 0.552 | - | - | - | - | |
| Changes in delayed visual M | ||||||
| Baseline | 10.36 ± 5.32 | 13.36 ± 5.32 | 0.134 | 4 vs baseline | 0.073 | 0.134 |
| 4 wk | 10.86 ± 5.34 | 15.13 ± 5.77 | 0.045 | 8 vs baseline | 0.161 | 0.036 |
| 8 wk | 10.90 ± 5.42 | 16.56 ± 6.46 | 0.015 | 12 vs baseline | 0.077 | 0.016 |
| 12 wk | 10.90 ± 5.50 | 17.40 ± 6.62 | 0.007 | Trend | 1 | 0.612 |
| P-value | 0.522 | - | - | - | - | |
a Values are expressed as mean ± SD.
