Depressive Disorder
Conditions
Interventions
Health Control Group:None
Control Group:Transcutaneous Cranio-Auricular Sham Stimulation
Experimental Group:Transcutaneous Cranio-Auricular Electrical Stimulation Treatment
Sponsors
Acupuncture and Rehabilitation Department of Jiangsu Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Meet the diagnostic criteria for mild to moderate depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5); 2) Aged between 18 and 65 years; 3) HAMD-17 score between 7 and 20; 4) Absence of suicide risk: All responses on the Suicide Severity Rating Scale (SSRS) must be negative; Item 3 (Suicide) of HAMD-17 must have a score < 3; 5) No use of any psychotropic substances or acupuncture treatment within the past 1 month; 6) Willing to receive transcutaneous electrical stimulation of auricular acupoints; 7) Able to cooperate with resting-state and task-state EEG monitoring comprehend scale content comply with treatment and provide written informed consent for voluntary participation.
Exclusion criteria
Exclusion criteria: 1) Comorbid severe somatic diseases such as coronary heart disease malignant tumors renal failure etc.; 2) Comorbid organic brain disorders; 3) Comorbid other psychiatric disorders personality disorders or substance abuse/dependence; 4) Inability to complete washout period for sleep-aid medications or acupuncture therapy; 5) Pregnant or lactating women; 6) Severe skin lesions in the auricular region; 7) Refusal to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMD-17; | — |
Secondary
| Measure | Time frame |
|---|---|
| Task-state EEG;PSQI;Resting-state EEG;APNI;Negative Cognitive Processing Bias Questionnaire;?-GABA Level;HAMA-14;Cortisol Level;5-HT Level;Chinese Medicine Constitution Classification and Judgment Self-Test Table;Resting-state ECG; | — |
Countries
China
Contacts
Public ContactChengyong Liu
Jiangsu Province Hospital of Chinese Medicine
Outcome results
None listed