Depression accompanied by insomnia
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–75 years, no gender restrictions. 2. Meets DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) diagnostic criteria for 'Depressive Disorder'. 3. Hamilton Depression Rating Scale (HAMD-17) total score between 17 and 23 points (moderate depression). 4. Meet DSM-5 diagnostic criteria for 'Insomnia Disorder' with a disease duration = 3 months. 5. Pittsburgh Sleep Quality Index (PSQI) score = 8. 6. No use of antidepressants, anxiolytics, or sedative-hypnotics within 2 weeks prior to enrolment; or stable maintenance of such medications for = 4 weeks. 7. Voluntary participation and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Secondary depressive disorder or insomnia arising from organic disease, medication, or psychiatric disorders. 2. Depressive episodes within bipolar affective disorder, or depressive or insomnia symptoms stemming from dysthymic disorder, reactive depression, or other conditions. 3. Severe diseases of vital organs (heart, liver, kidneys) or neurological disorders (e.g., epilepsy). 4. Individuals with implanted electronic devices (e.g., pacemakers, cochlear implants). 5. Presence of skin lesions, infections, or severe dermatological conditions at the treatment site (ear). 6. Pregnant or breastfeeding women. 7. Participants currently enrolled in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale;Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index Scale;Sleep Diary;Actigraphy;Self-rating Anxiety Scale;Fatigue severity scale;Epworth Sleepiness Scale;Heart rate variability; | — |
Countries
china
Contacts
Public Contactwangcong
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed