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Study on the mechanism of brain function of patients with primary insomnia by the effect of placebo effect and Pro-cognitive reappraisal

Phase 1
Conditions
insomnia
Registration Number
ITMCTR2000003281
Lead Sponsor
The First Affiliated Hospital of Hainan Medical College
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

The case comes from the primary insomnia patients in the Affiliated Hospital of Hainan Medical College. The normal controls were mainly from non blood relatives of outpatients. 1. In line with the classification scheme and diagnostic criteria for mental disorders of the Chinese society of psychiatry, sleep disorders are the only symptoms, and other symptoms are secondary to insomnia, including difficulty in falling asleep, not deep in sleep, easy to wake up, dreamy, wake up early, not easy to sleep again after waking up, and feel unwell, tired or sleepy during the day; 2. The above-mentioned sleep disorders occur at least three times a week, and remain For more than one month; 3. Insomnia causes significant distress, or a part of mental disorder symptoms, activity efficiency decreases, or hinders social function; 4. It is not any physical or mental disease, such as sleep apnea syndrome, periodic leg movements; 5. Excluding depression related insomnia, Hamilton Depression Scale, HAMD score < 17, Pittsburgh sleep quality index (PSQI > 8).

Exclusion Criteria

1. Patients with physical disease, mental disease and brain organic disease;
2. Pregnant or lactating women;
3. Those with alcohol and drug dependence or drug abuse history;
4. Those who need to use other psychoactive drugs other than the original hypnotics;
5. Those with obvious visual and hearing disorders;
6. Those who cannot complete the observation due to other reasons, according to the researcher.
Grouping: according to the method of random number table, the patients with primary insomnia were randomly divided into Anshen Dingzhi acupuncture treatment group, false acupuncture group, non Anshen Dingzhi acupuncture group, western medicine control group, normal control group with HAMA score < 7, PSQI score < 5, 20 cases in each group. There was no statistical difference in age, gender and education years in each group.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
BOLD-fmri;
Secondary Outcome Measures
NameTimeMethod
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