Generalized anxiety disorder with insomnia
Conditions
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Patients met the DSM-V diagnostic criteria for GAD and traditional Chinese medicine diagnostic criteria for "Yu Disease", accompanied by insomnia symptoms such as difficulty in falling asleep or maintaining sleep or waking up early. (2) Aged 18-75 years old, no gender limit. (3) 14 = HAMA score 10. (5) Hamilton Depression Scale (HAMD-17) score=17 and suicide factor score of HAMD-17 = 2. (6) Patients who did not change the regimen/dose of anti-anxiety drugs (escitalopram, paroxetine, venlafaxine, buspirone, duloxetine, tandospirone) or did not take any anti-anxiety drugs within last 4 weeks before the study. (7) No mental retardation, able to understand the terms of each scale and complete the assessment. (8) Agree to participate in this study and sign written informed consent.
Exclusion criteria
Exclusion criteria: (1) Severe heart, liver, kidney, or other major diseases. (2) Excluding anxiety disorders caused by other physical illnesses (such as hyperthyroidism, pheochromocytoma, etc.). (3) Excluding other types of anxiety disorders (such as social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder), schizophrenia spectrum and other psychotic disorders, bipolar disorders, etc. (4) Patients who are pregnant or breastfeeding. (5) History of drug abuse or addiction.; (6) Patients who changed their sedative-hypnotic medication regimen/dose within 2 weeks before the baseline visit, or who received other treatments for insomnia (such as cognitive behavioral therapy) within 3 months before the baseline visit, which might affect the observation of efficacy; (7) Patients with long-term night shift work or irregular sleep-wake schedules; (8) Patients who participated in other clinical medical trials within the last 2 months; (9) With other organic sleep problems, such as sleep apnea syndrome, restless legs syndrome, etc.; (10) Contraindications for acupuncture treatment: such as having other severe life-threatening underlying diseases, or if the selected acupuncture points area has ulcers, abscesses, skin infections, limb deficiencies, etc., making it impossible to perform acupuncture treatment; (11) Individuals with a pacemaker installed; (12) Metal allergy or severe fear of needles.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the Pittsburgh Sleep Quality Index(PSQI) score compared to the baseline at week 8; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in The Hamilton Anxiety Rating Scale score;The change in the Pittsburgh Sleep Quality Index(PSQI) score compared to the baseline at other weeks;The change in Insomnia Severity Index (ISI) score;Sleep diary;12-item Short-Form Health Survey (SF-12) scores;Actigraphy sleep quality monitoring related indicators;Medication usage; | — |
Countries
China
Contacts
Public ContactChen Yuelai
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed