Insomnia
Conditions
Interventions
"Yu-Le Relaxation" Group:Sleep hygiene education combined with "Yu-Le Relaxation" training.
Sleep Hygiene Education Group:Sleep hygiene education only.
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Science
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Meeting the DSM-V diagnostic criteria for insomnia. 2.Meeting the TCM diagnostic criteria for Disharmony between Heart and Kidney syndrome. 3.Age between 18-65 years with no gender restrictions. 4.Insomnia Severity Index (ISI) score between =8 and =21. 5.The patient voluntarily agrees to participate and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with severe depressive symptoms with a Patient Health Questionnaire-9 (PHQ-9) score =20. 2.Patients with severe anxiety symptoms with a Generalized Anxiety Disorder-7 (GAD-7) score =15. 3.Patients with severe mental illnesses such as manic episodes or schizophrenia. 4.Patients with a PHQ-9 score of =2 on item 9 indicating serious suicidal ideation. 5.Patients with severe hearing impairment. 6.Patients with severe tinnitus. 7.Patients who have participated in other clinical trials for insomnia treatment within the past 3 months. 8.Patients with alcohol or drug dependence within the past year. 9.Patients who have been taking sedative-hypnotics or antidepressants with sedative-hypnotic effects continuously for the past two months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index(ISI); | — |
Secondary
| Measure | Time frame |
|---|---|
| polysomnography(PSG);Patient Health Questionnaire (PHQ-9);Generalized Anxiety Scale (GAD-7);TCM syndrome score(Disharmony between Heart and Kidney);Pittsburgh Sleep Quality Index (PSQI); | — |
Countries
China
Contacts
Public ContactXia Hong
Xiyuan Hospital of China Academy of Chinese Medical Science
Outcome results
None listed