Insomnia Disorder With Depressive Features
Conditions
Interventions
Active tTIS Group:tTIS stimulation targeting the right sgACC, carrier frequencies of 2000Hz and 2005Hz, output current of 2.5mA, continuous for 5 days, twice daily, each session lasting 30 minutes
Sham tTIS Group:Sham stimulation
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–60 years, of either sex, right-handed. 2. Meeting the diagnostic criteria for chronic insomnia disorder according to the International Classification of Sleep Disorders, Third Edition (ICSD-3) or the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), defined as difficulty initiating sleep, difficulty maintaining sleep, or early morning awakening, occurring at least 3 times per week for a duration of at least 3 months. 3. Insomnia Severity Index (ISI) score >= 15. 4. Hamilton Depression Rating Scale (HAMD-17) total score >= 8. 5. Stable psychiatric medication regimen, defined as no change in psychotropic medications for at least 4 weeks prior to enrollment, or no initiation of new psychotropic medications within 4 weeks before enrollment. 6. No initiation of new structured psychotherapy within 4 weeks prior to enrollment. 7. Ability to understand the study objectives and procedures and to provide informed consent. 8. Willingness to participate in the study and provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1. HAMD-17 total score >= 20; HAMD-17 item 3 (suicide) score >= 3; or a history of suicide attempt. 2. History of psychotic disorders or manic episodes, including bipolar disorder, schizophrenia, or other psychotic disorders; autism spectrum disorder or intellectual disability; or current severe obsessive–compulsive disorder, post-traumatic stress disorder (PTSD), or eating disorders that significantly impair functioning. 3. Severe cognitive impairment as assessed by cognitive screening tools (Mini-Mental State Examination [MMSE] or Montreal Cognitive Assessment [MoCA]). 4. Other sleep disorders, including restless legs syndrome, obstructive sleep apnea, narcolepsy, or other clinically significant sleep disorders. 5. Substance use–related problems, including moderate to severe alcohol or substance use disorder within the past 6 months; or moderate to severe nicotine dependence (>=10 cigarettes per day or Fagerström Test for Nicotine Dependence [FTND] score >=4). 6. Suicide risk, defined as a suicide attempt within the past 12 months, or the presence of a current, explicit suicide plan deemed clinically inappropriate for study participation. 7. Neurological disorders, including epilepsy, stroke, loss of consciousness due to traumatic brain injury, intracranial tumors, demyelinating diseases, or other confirmed organic brain diseases. 8. Severe or unstable medical conditions, such as uncontrolled cardiovascular disease, severe hepatic or renal insufficiency, uncontrolled endocrine disorders, or other conditions judged by the investigator to increase study-related risk. 9. Contraindications to tTIS or MRI, including metallic implants or other MRI contraindications; severe skin lesions at the stimulation sites; or severe claustrophobia. 10. Pregnancy or breastfeeding. 11. Any other condition judged by the investigator to make the participant unsuitable for inclusion.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Rating Scale for Depression(HAMD-17);Pittsburgh Sleep Quality Index(PSQI);Functional near-infrared spectroscopy(fNIRS); | — |
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index (ISI); | — |
Countries
China
Contacts
Public ContactZhu Zhou
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed