TIS for NSSI in Adolescent Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-22
SponsorThe Second Hospital of Anhui Medical University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) diagnostic criteria for major depressive disorder.
Patients aged 12-22 years with at least one guardian to monitor them for 3 months
HAMD-17 Total score ≥18
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Active Temporal Interference Stimulation (TIS)
DeviceActive 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 Temporal Interference Stimulation (TIS)
DeviceSham 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: real stimulationActive comparator 1 intervention
Group B: sham stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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."
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 TIS2
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 TISSecondary outcomes
1
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 TIS2
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 TIS3
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 TIS4
Changes in Ruminative Responses Scale (RRS)
Range from 22 to 88. Higher scores indicate higher levels of ruminative thinking.
Time frame
Baseline, the day after the end of TISOther outcomes
1
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.
Time frame
Baseline2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Recording any side effects in the adverse event record form (AERF).
Time frame
The day after the end of TISSponsors and contacts
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Source ClinicalTrials.gov