Major Depressive Disorder, Non Suicidal Self Injury, Temporal Interference Stimulation
Conditions
Brief summary
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).
Detailed description
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).
Interventions
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.
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.
Sponsors
The Second Hospital of Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 22 Years
Healthy volunteers
No
Inclusion criteria
1. Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) diagnostic criteria for major depressive disorder. 2. Patients aged 12-22 years with at least one guardian to monitor them for 3 months 3. HAMD-17 Total score ≥18 4. Patients who had two or more non-suicidal self-injury behaviors meeting the 5.DSM-5 diagnostic criteria in the 2 weeks before admission (NSSI behavior of more than 5 days in the past year) 6.Obtain informed consent from patients and guardians \-
Exclusion criteria
1. Substance abusers such as psychoactive drugs or alcohol. 2. Severe physical disability and unable to complete follow-up. 3. 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. 4. 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. 5. Any implants covering a pacemaker, metallic or magnetic objects in the body, or other conditions not suitable for TIS. 6. Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) or TMS within 3 months before baseline. 7. Other examination abnormalities considered to be inappropriate by investigators. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Adolescent Non-Suicidal Self-Injurious Behavior Assessment Questionnaire (ANSAQ) | 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 | 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." |
| Changes in the 17-item Hamilton Rating Scale for Depression (HAMD-17) | 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 | Range from 0-52, higher score indicates more severe symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Hamilton Anxiety Scale (HAMA) | 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 | Range from 0-56, higher score indicates more severe symptoms |
| Change in the Patient Health Questionnaire-15 (PHQ-15) | 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 | Range from 0 to 30, higher score indicates more severe somatic symptoms. |
| Changes in Insomnia Severity Index (ISI) | 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 | Range from 0 to 28. Higher scores indicate more severe insomnia symptoms. |
| Changes in Ruminative Responses Scale (RRS) | Baseline, the day after the end of TIS | Range from 22 to 88. Higher scores indicate higher levels of ruminative thinking. |
| Changes in Beck Suicidal Scale Inventory (BSI) | Baseline, the day after the end of TIS | Range from 0- 38, higher score indicates more severe suicide ideation. |
| Chinese version of the Barratt Impulsiveness Scale | Baseline, the day after the end of TIS | 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. |
| Changes in the Chinese version of the Buss & Perry Aggression Questionnaire | Baseline, the day after the end of TIS | 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. |
| Changes in Pain Vigilance and Awareness Questionnaire (PVAQ) | Baseline, the day after the end of TIS | Range from 0 to 80. Higher scores indicate greater pain-related attention and hypervigilance. |
| Changes of high-resolution T1-weighted anatomical images | Baseline, the day after the end of TIS | T1-weighted images will be acquired using 3D inversion recovery-prepared fast spoiled gradient-echo sequences. |
| Changes of blood oxygenation level dependent (BOLD) functional imaging signals | Baseline, the day after the end of TIS | Resting-state MRI (rs-MRI) will be used to exam the change of brain function. |
| Changes of Diffusion Tensor Imaging | Baseline, the day after the end of TIS | Diffusion Tensor Imaging (DTI) will be performed using diffusion-weighted echo planar imaging sequences. |
Countries
China
Contacts
CONTACTYanghua Tian, PhD
CONTACTHongping Wang
Outcome results
None listed