Depression
Conditions
Interventions
Depression with Non-Suicidal Self-Injury TIS True Stimulation Group:Temporal interference stimulation
Depression with Non-Suicidal Self-Injury TIS Sham Stimulation Group:none
Depression without Non-Suicidal Self-Injury (NSSI) TIS True Stimulation Group:Temporal interference stimulation
Depression without Non-Suicidal Self-Injury (NSSI) TIS Sham Stimulation Group:none
Sponsors
Shandong Daizhuang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Inclusion Criteria for Depression with Self-Injury: (1)Meets DSM-5 diagnostic criteria for depressive disorder as confirmed by the Structured Clinical Interview for DSM-5 (SCID-5). (2)Aged between 10 and 18 years. (3)Voluntarily participates in the study, with consent from a parent or guardian, and provides written informed assent/consent. (4)Able to comprehend written language and complete self-report questionnaires. (5)Scores above 18 on the 24-item Hamilton Depression Rating Scale (HAMD-24). (6)Of Han Chinese ethnicity and right-handed. (7)Has had no changes in treatment regimen for at least 4 weeks prior to enrollment, and agrees to maintain a stable treatment protocol throughout the study period. (8)Presence of non-suicidal self-injury (NSSI) behavior, defined as selecting "at least once" or higher (corresponding to a score >= 1) on the Ottawa Self-Injury Inventory item explicitly inquiring about the occurrence of self-injurious behaviors. 2.Inclusion Criteria for Depression without Self-Injury: (1)Meets DSM-5 diagnostic criteria for depressive disorder as confirmed by the Structured Clinical Interview for DSM-5 (SCID-5). (2)Aged between 10 and 18 years. (3)Voluntarily participates in the study, with consent from a parent or guardian, and provides written informed assent/consent. (4)Able to comprehend written language and complete self-report questionnaires. (5)Scores above 18 on the 24-item Hamilton Depression Rating Scale (HAMD-24). (6)Of Han Chinese ethnicity and right-handed. (7)Has had no changes in treatment regimen for at least 4 weeks prior to enrollment, and agrees to maintain a stable treatment protocol throughout the study period. (8)Absence of non-suicidal self-injury (NSSI) behavior, defined as selecting "never" (score = 0) on the Ottawa Self-Injury Inventory item explicitly inquiring about the occurrence of self-injurious behaviors..
Exclusion criteria
Exclusion criteria: 1.Exclusion Criteria for Depression with Self-Injury: (1)History of substance dependence; presence of any psychiatric disorder other than depressive disorder meeting the diagnostic criteria on SCID Axis I; history of traumatic brain injury, epilepsy, or other organic brain disorders. (2)Laboratory tests indicating impaired liver or kidney function, or other severe physical illnesses or metabolic disorders. (3)Contraindications for TIS or fMRI scanning, such as cardiac pacemakers, intravascular metal implants, orthodontic braces, or claustrophobia. (4)Intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metallic objects in or near the head that cannot be safely removed. (5)Any neurological disorder or severe systemic medical condition. (6)Use of medications that may interfere with TIS treatment effects, such as barbiturates, benzodiazepines, and certain anticonvulsants. (7)History of electroconvulsive therapy (ECT) within the 6 months prior to enrollment. 2.Exclusion Criteria for Depression without Self-Injury: The exclusion criteria for the depression without self-injury group are identical to those listed above for the depression with self-injury group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The therapeutic effects of TIS on depressive symptoms, anhedonia, self-injury, and trauma in patients with major depressive disorder;Acute neuro-electrophysiological changes—evident in both resting-state and task-based brain activity—elicited by temporal-interference stimulation (TIS) prospectively predict symptom improvement in patients with major depressive disorder; | — |
Secondary
| Measure | Time frame |
|---|---|
| TIS induces acute, state-dependent neuro-electrophysiological shifts—both at rest and during task states—that prospectively forecast clinical improvement in patients with major depressive disorder;TIS optimizes behavioral indices of feedback processing and emotion regulation in patients with major depressive disorder.;This study characterizes the individualized post-TIS trajectories of major depressive disorder patients, capturing their unique shifts in resting-state and task-evoked neuro-electrophysiology, behavioral indices of feedback processing and emotion regulation, and clinical markers spanning depressive symptoms, anhedonia, emotion-regulation capacity, self-injury, and trauma.; | — |
Countries
china
Contacts
Public ContactKun Li
Shandong Daizhuang Hospital
Outcome results
None listed