Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Temporal Interference Stimulation (TIS) has been successfully used to help patients with depression. However, its role in alleviating self injuries remained uncertain. This trial will compare the effectiveness of TIS to a placebo control on non-suicidal self injury (NSSI) in patients with major depressive disorder(MDD).
The study will evaluate the efficacy and safety of TIS in depressive patients with NSSI behaviors by measuring changes in clinical ratings at baseline, after all the treatments, and 2 weeks, 4 weeks, 8 weeks after treatment. 60 inpatients will be randomized to receive active or sham interventions administered to the right subgenual anterior cingulate cortex. The treatment will apply TIS involving 2x daily at 30 minutes for 5-7 days.
Changes in mood from baseline to the end of the study will be measured with The Hamilton Rating Scale for Depression-17 item (HAMD-17), Hamilton Anxiety Scale (HAMA). Non-suicidal self injury will be assessed by the Adolescent Non-Suicidal Self-Injury Assessment Questionnaire (ANSAQ). Suicidal ideation and behaviors assessments will be measured with Beck Suicidal Scale Inventory (BSI). Changes in somatic symptom severity from baseline to the end of the study will be measured with the Patient Health Questionnaire-15 (PHQ-15). Sleep quality and disturbances will be assessed by the Pittsburgh Sleep Quality Index (PSQI). Insomnia severity will be evaluated using the Insomnia Severity Index (ISI). Ruminative thinking styles will be measured with the Ruminative Responses Scale (RRS). Impulsivity and aggression assessments will be measured with the Barratt Impulsiveness Scale (BIS) and the Buss-Perry Aggression Questionnaire (BPAQ), respectively. Additionally, pain-related attention and hypervigilance will be assessed by the Pain Vigilance and Awareness Questionnaire (PVAQ). Adverse event record form (AERF) will be used to appraise the safety of TIS treatment. Changes of brain structure and brain activities will be acquired by pre and post-interventional magnetic resonance imaging (MRI).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| real stimulation | Active Comparator | Participants will receive active TIS 10 to 14 times. |
|
| sham stimulation | Sham Comparator | Participants will receive sham TIS 10 to 14 times. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Temporal Interference Stimulation (TIS) | Device | Active stimulation to the right subgenual anterior cingulate cortex; 2 sessions per day, 30 minutes per session, including a 30-second current ramp-up at the beginning and a 30-second ramp-down at the end, for 5-7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Adolescent Non-Suicidal Self-Injurious Behavior Assessment Questionnaire (ANSAQ) | Containing one subscale evaluating the frequency and primary methods of self-injury behaviors in patients over the past 2 weeks,and one subscale ranging from 0 to 10 to assess the self-injurious thoughts, with 0 indicating "not at all" and 10 indicating "very strongly." | Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS |
| Changes in the 17-item Hamilton Rating Scale for Depression (HAMD-17) | Range from 0-52, higher score indicates more severe symptoms | Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Hamilton Anxiety Scale (HAMA) | Range from 0-56, higher score indicates more severe symptoms | Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS |
| Change in the Patient Health Questionnaire-15 (PHQ-15) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Pittsburgh Sleep Quality Index (PSQI) | Total score ranges from 0 to 21. Higher scores indicate poorer overall sleep quality and more severe sleep disturbances. | Baseline |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] |
Inclusion Criteria:
6.Obtain informed consent from patients and guardians
-
Exclusion Criteria:
Substance abusers such as psychoactive drugs or alcohol.
Severe physical disability and unable to complete follow-up.
Comorbid other major mental illnesses that meet the DSM-5 criteria, such as bipolar disorder, schizophrenia, mental retardation, dementia, severe cognitive impairment, attention deficit hyperactivity disorder, etc.
Suffering from any severe physical disease, neurological disease, traumatic brain injury, etc, that affects the structure or function of the brain in the lifetime.
Unable to read, understand and complete the assessment or to cooperate with the investigators.
Any implants covering a pacemaker, metallic or magnetic objects in the body, or other conditions not suitable for TIS.
Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) or TMS within 3 months before baseline.
Other examination abnormalities considered to be inappropriate by investigators.
-
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanghua Tian, PhD | Contact | +86-13955188448 | tianyh@ahmu.edu.cn | |
| Hongping Wang | Contact | +86-18256001073 | medstuwhp@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230022 | China |
Not provided
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham Temporal Interference Stimulation (TIS) | Device | Sham stimulation had only 30 seconds of current ramping-up and ramping-down at the beginning and end of the stimulation, respectively, to simulate the sensation of actual stimulation. |
|
Range from 0 to 30, higher score indicates more severe somatic symptoms. |
| Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS |
| Changes in Insomnia Severity Index (ISI) | Range from 0 to 28. Higher scores indicate more severe insomnia symptoms. | Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS |
| Changes in Ruminative Responses Scale (RRS) | Range from 22 to 88. Higher scores indicate higher levels of ruminative thinking. | Baseline, the day after the end of TIS |
| Changes in Beck Suicidal Scale Inventory (BSI) | Range from 0- 38, higher score indicates more severe suicide ideation. | Baseline, the day after the end of TIS |
| Chinese version of the Barratt Impulsiveness Scale | Total score ranges from 0 to 100. It is converted from a 30-item raw score based on a 5-point scale. Higher scores indicate greater levels of impulsivity. | Baseline, the day after the end of TIS |
| Changes in the Chinese version of the Buss & Perry Aggression Questionnaire | Total score ranges from 0 to 100. It is mathematically converted from the sum of the raw item scores. Higher scores indicate greater levels of aggression. | Baseline, the day after the end of TIS |
| Changes in Pain Vigilance and Awareness Questionnaire (PVAQ) | Range from 0 to 80. Higher scores indicate greater pain-related attention and hypervigilance. | Baseline, the day after the end of TIS |
| Changes of high-resolution T1-weighted anatomical images | T1-weighted images will be acquired using 3D inversion recovery-prepared fast spoiled gradient-echo sequences. | Baseline, the day after the end of TIS |
| Changes of blood oxygenation level dependent (BOLD) functional imaging signals | Resting-state MRI (rs-MRI) will be used to exam the change of brain function. | Baseline, the day after the end of TIS |
| Changes of Diffusion Tensor Imaging | Diffusion Tensor Imaging (DTI) will be performed using diffusion-weighted echo planar imaging sequences. | Baseline, the day after the end of TIS |
Recording any side effects in the adverse event record form (AERF).
| The day after the end of TIS |
| D001523 |
| Mental Disorders |