Table 1 Participant timeline
Study Flow Chart | ||||||
|---|---|---|---|---|---|---|
Phase | Baseline period | Period of treatment | Period of follow-up | |||
Number of visits | 1 | 2 | 3 | 4 | 5 | 6 |
Time (weeks) | Week 0 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 |
Inclusion/exclusion criteria | √ |  |  |  |  |  |
Informed consent obtained | √ |  |  |  |  |  |
Demographic data | √ |  |  |  |  |  |
Medical history and treatment history collected | √ |  |  |  |  |  |
Pittsburgh Sleep Quality Index (PSQI) | √ | √ | √ |  |  | √ |
Wisconsin Card Sorting Test (WCST) | √ | √ | √ |  |  | √ |
EEG acquisition record sheet | √ |  | √ |  |  | √ |
Adverse event acupuncture record | √ | |||||
Combined medication records | √ | |||||
Adverse event (AE) recording form | √ | |||||
Serious Adverse Event (SAE) report form | √ | |||||
Treatment-Emergent Symptom Scale | √ | |||||
Assessment of adherence | √ | |||||
Study completion | √ | |||||
Review by investigators | √ | |||||