Depression State
Conditions
Interventions
Experimental Group:Noninvasive Neuromodulation Therapy of Acoustic Stimulation and Antidepressant Medicine Therapy
Control Group:Antidepressant Medicine Therapy
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
16 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.The age range is 16-80 years old; 2.Meet the diagnostic criteria of ICD-11 insomnia and depression, PSQI score is not less than 11 points and SDS score is not less than 53 points; 3.Junior high school education or higher level, with basic reading and writing skills. 4.With informed consent from the individual and legal guardian obtained.
Exclusion criteria
Exclusion criteria: 1. History of major systemic diseases (e.g., severe cardiac, cerebral, hepatic, or hematopoietic disorders) or other severe conditions affecting life expectancy; 2.Diagnosis of psychiatric disorders (e.g., schizophrenia, bipolar disorder, etc.); 3.Those with abnormal hearing or vision that has not been restored with physical assistance; 4.History of alcohol/substance abuse or psychoactive substance use; 5.Inability to complete psychological assessments; 6.Refusal to participate by the individual or legal guardian; 7.Patients with hyperacusis who have not recovered after desensitization therapy; 8.Current participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI) Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-Rating Anxiety Scale (SAS) Score;Insomnia Severity Index (ISI) Scale Score;Melatonin Concentration;N2 Stage Sleep Duration;Total sleep time;Sleep Onset Latency;Neurotransmitter Concentration;Self-Rating Depression Scale (SDS) Score;Rapid eye movement sleep latency;REM Stage Sleep Duration;Oxidative Stress Biomarker Concentration;Hamilton Anxiety Rating Scale (HAMA) Score;Cytokine Concentration;Scores of HAMD;N3 Stage Sleep Duration;N1 Stage Sleep Duration;Blood fat;Fast blood -glucose; | — |
Countries
China
Contacts
Public ContactLi Jing
Sichuan Provincial People's Hospital
Outcome results
None listed