Activity | Phase (time point) | Screening/enrolment (week0) | Allocation | Treatment/intervention | Follow-up | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Weeks 1 | Weeks 2 | Weeks 3 | Weeks 4 | Weeks 5 | Weeks 6 | Weeks 7 | Weeks 8 | Weeks 12 | ||||
Enrolment | Eligibility screening | √ |  |  |  |  |  |  |  |  |  |  |
Acquisition of informed consent | √ |  |  |  |  |  |  |  |  |  |  | |
Clinicopathological evaluation | √ |  |  |  |  |  |  |  |  |  |  | |
Enrolment | √ |  |  |  |  |  |  |  |  |  |  | |
Random allocation |  | √ |  |  |  |  |  |  |  |  |  | |
Treatment/intervention | Abdomen-rubbing qigong exercise |  |  | √ | √ | √ | √ | √ | √ | √ | √ |  |
Cognitive behavioral therapy for insomnia |  |  | √ | √ | √ | √ | √ | √ | √ | √ |  | |
Outcome assessment | PSQI | √ |  |  |  |  | √ |  |  |  | √ | √ |
ISI | √ |  |  |  |  | √ |  |  |  | √ | √ | |
GSRS | √ |  |  |  |  | √ |  |  |  | √ | √ | |
HAMD | √ |  |  |  |  | √ |  |  |  | √ | √ | |
Safety observation | fMRI | √ |  |  |  |  |  |  |  |  | √ |  |
Adverse event |  |  | √ | √ | √ | √ | √ | √ | √ | √ | √ | |
drug combination |  |  | √ | √ | √ | √ | √ | √ | √ | √ | √ |