|
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
| | |
√
|
√
|
√
|
√
|
√
|
√
|
√
|
√
|
√
|
