Efficacy of the Six Healing Sound Qigong Exercise Combined with Cognitive Behavioral Therapy for Insomnia

Phase 1

Recruiting

• Conditions: insomnia disorder

• Registration Number: ITMCTR2022000088
• Lead Sponsor: Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1 The patients with insomnia as the main complaint were diagnosed as insomnia disorder according to the diagnostic and Statistical Manual of mental disorders (DSM-V) prepared by the American Psychiatric Association, with typical insomnia symptoms
2 Patients living in high altitude areas
3 PSQI = 8 points
4 Age: 18-55
5 Junior high school or above
6 Volunteer to participate in this study and sign informed consent.

Exclusion Criteria

1 Combined with diseases that have not been effectively controlled or are extremely serious, such as persistent pain caused by various reasons, malignant tumors, cardiovascular and cerebrovascular diseases, neuroendocrine diseases, neuromuscular diseases and digestive tract diseases, which lead to insomnia disorders;
2 Self rating Depression Scale (SDS) > 73);
3 Use of alcohol and / or other drugs or dependent drugs;
4 Had suffered from depression or other mental diseases within 6 months before enrollment;
5 Those who were treated with insomnia drugs within 1 month before enrollment;
6 Those who participated in any other clinical trial within 1 month before baseline;
7 Pregnant and lactating patients.
8 Unable to cooperate with the treatment.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference of Pittsburgh sleep quality index before and after treatment;

Secondary Outcome Measures

Name	Time	Method
Difference of self rating Anxiety Scale before and after treatment;Difference of Proteomics and Metabonomics before and after treatment;Difference of Insomnia Severity Index before and after treatment;Difference of self rating Depression Scale before and after treatment;Difference of multidimensional fatigue questionnaire before and after treatment;Difference of TCM Syndrome Scale before and after treatment;