A Randomized Controlled Trial for the Treatment of Chronic Insomnia with Relaxation Training of 'Yule'
- Conditions
- chronic insomnia
- Registration Number
- ITMCTR2200006629
- Lead Sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1) Meet the diagnostic criteria of DSM-V insomnia;
2) Age 18-65 years old;
3) Significant daytime dysfunction (i.e. ISI item 5 [daytime dysfunction] = 3);
4) Insomnia Severity Index Scale (ISI) = 15 points;
5) The patient or family members signed the informed consent.
1) Patients with severe depressive symptoms, Patient Health Questionnaire-9 (PHQ-9) = 20;
2) Patients with severe anxiety symptoms, Generalized Anxiety Scale-7 (GAD-7) = 15;
3) Combined with severe mental illness, such as manic episodes, schizophrenia;
4) Imminent suicide risk, Item 9 of Patient Health Questionnaire-9 (PHQ-9) = 2 points;
5) Patients with severe hearing impairment;
6) Patients with severe tinnitus;
7) Unsupervised or unable to take medicine as prescribed by a doctor;
8) Those who have received other clinical trials for the treatment of insomnia within 3 months;
9) Alcohol or drug dependence within one year;
10) Continuous use of benzodiazepine sedative and hypnotic drugs for the past two months.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Insomnia Severity Index Scale (ISI);
- Secondary Outcome Measures
Name Time Method Patient Health Questionnaire-9 (PHQ-9);Pittsburgh Sleep Quality Index (PSQI);Generalized Anxiety Scale (GAD-7);