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A Randomized Controlled Trial for the Treatment of Chronic Insomnia with Relaxation Training of 'Yule'

A Randomized Controlled Trial for the Treatment of Chronic Insomnia with Relaxation Training of 'Yule'

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006629
Enrollment
Unknown
Registered
2022-09-20
Start date
2022-09-20
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic insomnia

Interventions

"Yu tune" music relaxation training group:Jianpi Jieyu Decoction combined with "Yu Tune" music relaxation training
control group:Jianpi Jieyu Decoction

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Insomnia Severity Index Scale (ISI);

Secondary

MeasureTime frame
Patient Health Questionnaire-9 (PHQ-9);Pittsburgh Sleep Quality Index (PSQI);Generalized Anxiety Scale (GAD-7);

Countries

China

Contacts

Public ContactXia Hong
970236538@qq.com+86 13699207252

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026