Adolescent Generalized Anxiety Disorder
Conditions
Interventions
Treatment Group:During the treatment, the electrode positions were localized using the international 10-20 electroencephalogram (EEG) electrode placement system. Active stimulation group: Photoelectri
Electrical stimulation parameters: 1 Hz at 2 mA. Stimulation sites: cathode placed at the right frontal F4, anode at Fp1. Treatment regimen: 20 minutes per session, once daily for 14 consecutive days.
Control Group:During the treatment, electrode positions were localized using the international 10-20 electroencephalogram (EEG) electrode placement system.Sham stimulation group: The procedures and se
Sponsors
The First Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
13 Years to 17 Years
Inclusion criteria
Inclusion criteria: Meets the diagnostic criteria for Generalized Anxiety Disorder (GAD) in the DSM-5; Aged 13 to 17 years, of any gender, right-handed; A score of =14 points on the Hamilton Anxiety Scale (HAMA); Patients taking anti-anxiety medications are not required to discontinue treatment, but the type, administration route and dosage of medications shall remain unchanged for four weeks before treatment, during the entire treatment course and for two months after treatment completion; No positive findings on neurological physical examination; Sufficient visual and auditory ability to complete the questionnaire filling, examinations and therapeutic interventions required for the study; Voluntarily agrees to participate in the study and signs the Informed Consent Form (ICF) for research subjects.
Exclusion criteria
Exclusion criteria: Exclusion of other anxiety disorders diagnosed in accordance with DSM-5, including panic disorder, social phobia, obsessive-compulsive disorder, post-traumatic stress disorder, agoraphobia and specific phobias; Exclusion of patients with a score of =20 points on the Hamilton Depression Rating Scale (HAMD); Exclusion of secondary anxiety caused by other organic diseases, such as that induced by severe hepatic, renal and cardiac diseases, severe trauma, etc.; Exclusion of subjects with a history of brain surgery or epilepsy; Exclusion of patients with medication dosage adjustments during the treatment course; Exclusion of subjects with metallic foreign bodies in the body, such as those with cardiac pacemakers, deep brain stimulation (DBS) devices, stents, etc.; Exclusion of subjects who have suffered from other mental disorders or had substance/drug abuse or dependence within 6 months prior to enrollment; Exclusion of any other circumstances deemed inappropriate for study participation by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Rating Scale (HAMA) Score;Hamilton Depression Rating Scale-24 (HAMD-24) Score;Pittsburgh Sleep Quality Index (PSQI) Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time-varying Brain Network Analysis via Transcranial Magnetic Stimulation-Electroencephalography (TMS-EEG);Resting-state Functional MRI (fMRI) Analysis (including: Functional Connectivity Analysis, Whole-brain Network Properties, Local Brain Function Analysis); | — |
Countries
China
Contacts
Public ContactWang Yuping
The First Hospital of Hebei Medical University
Outcome results
None listed