Chronic primary insomnia with anxiety
Conditions
Interventions
"Calming the Mind and Regulating the Spirit" electroacupuncture group: "Calming the Mind and Regulating the Spirit" electroacupuncture
Sham electroacupuncture group :Sham electroacupuncture
Wait list group:No treatment during the trial period
Sponsors
Shenzhen Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Participants for this study must meet the following criteria: (1) Diagnosed with chronic primary insomnia according to the International Classification of Sleep Disorders, Third Edition (ICSD-3) and the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). (2) Experiencing insomnia symptoms for at least three months, occurring at least three nights per week. (3) Aged between 18 and 50 years, with no restrictions on gender.(4)The PSQI score >7 points;The ISI score =15 points,and=21points;The HAMA score >7points,and <21points;The HAMD-17 score < 7 points;(5) Participants must not have taken any western, herbal, or nutraceutical medications (e.g., melatonin) or received non-pharmacological treatments (e.g., Cognitive Behavioral Therapy, Mindfulness Therapy) for anxiety, depression, or insomnia for at least four weeks prior to enrollment and during the study. (6) All participants must be right-handed. (7) Women of childbearing age must agree to use appropriate contraception throughout the study period. (8) All participants must voluntarily participate and sign an informed consent form. This clear and structured approach ensures the eligibility criteria are meticulously defined to uphold the integrity and reliability of the research outcomes.
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study based on the following criteria: (1) History or imaging evidence of cerebrovascular disease, head trauma, other neurological disorders such as epilepsy and neurodegenerative diseases, or severe mental disorders including depression as diagnosed according to DSM-V. (2) Presence of other sleep disorders such as Restless Legs Syndrome, Sleep Apnea Syndrome, and Narcolepsy. (3) Women who are pregnant, planning pregnancy, currently breastfeeding, or who may become pregnant. (4) Cases of insomnia caused by diseases, jet lag, significant life changes, surgery, or night shift work. (5)History of alcohol, drug abuse, significant caffeine consumption and/or use of central nervous stimulants, analgesics, sedatives, antipsychotic medications like antidepressants or anti-anxiety drugs within four weeks before enrollmen. (6) Serious internal diseases including cardiovascular, cerebral, hepatic, renal, and hematological disorders, malignant tumors, benign prostatic hyperplasia, and infectious diseases like tuberculosis, HIV, and syphilis. (7) Recent acupuncture treatment or severe skin damage or infections at potential acupuncture sites within the last month. (8) Participation in other clinical trials within the past three months. (9) MRI contraindications such as claustrophobia, presence of metal braces, dentures, dental implants, or other metal implants in the body. (10) Abnormal findings on brain MRI such as unusual signal intensity, significant head structure asymmetry, brain structure damage, fear of MRI procedures, or incomplete MRI scans.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index(PSQI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index(ISI);Hamilton Anxiety Scale(HAMA);Hamilton Depression Scale 17 items(HAMD-17);the 12–items Short Form Health Survey(SF-12);5-Hydroxytryptamine;norepinephrine ;Melatonin;resting-state functional magnetic resonance imaging ; | — |
Countries
China
Contacts
Public ContactLi Nuo
Shenzhen Hospital, Beijing University of Chinese Medicine
Outcome results
None listed