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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
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.
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGChanges 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."
Time frame: 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
Time frame: 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 Hamilton Anxiety Scale (HAMA)
Range from 0-56, higher score indicates more severe symptoms
Time frame: 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)
Range from 0 to 30, higher score indicates more severe somatic symptoms.
Time frame: 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.
Time frame: 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)
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Range from 22 to 88. Higher scores indicate higher levels of ruminative thinking.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, the day after the end of TIS