perimenopausal depression accompanying insomnia
Conditions
Interventions
acupuncture group:acupuncture
sham acupuncture group:sham acupuncture
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
45 Years to 55 Years
Inclusion criteria
Inclusion criteria: (1) Aged 45-55 years; (2) Experiencing the perimenopausal phase; (3) Meeting the International Classification of Diseases-Ten Edition (ICD-10) diagnostic criteria for mild or moderate depressive episode and International Classification of Sleep Disorders-Third Edition (ICSD-3) diagnostic criteria for insomnia; Minimum duration of the depression episode accompanying insomnia is about four weeks; (4) 8 points 5 points; (6) In accordance with the diagnostic criteria for Depression of Liver and Deficiency of Kidney in TCM theory; (7) Volunteering to join this trial and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Belong to non-natural menopause transition due to premature ovarian failure, medication intake, or surgery (e.g., oophorectomy); (2) Are pregnant or currently lactating; (3) Depression or insomnia is caused by systemic diseases (e.g., stroke, Parkinson's disease, surgery, etc.); (4) Are diagnosed as severe depressive episode according to ICD-10 and/or have ideas or acts of suicide; (5) Had a depressive disorder diagnosis prior to perimenopausal phase; (6) Comorbid with other psychiatric and mental disorders, other depression-related disorder, or sleep-related disorders diagnosed by DSM-V and ICD-10 in addition to depression and insomnia; (7) Take medications (e.g., antidepressant, hypnotic, other psychotropic substances, Chinese herbal medicine, etc.) and/or health care products (e.g., melatonin, black cohosh, etc.), or receive other therapies (e.g., CBT, Mindfulness-Based Exercise, etc.) that are intended to treat depression and insomnia within the last one month prior to the commencement of this trial; (8) Receive hormones therapy within the last two months prior to the commencement of this trial; (9) Had acupuncture treatment experience in the past 3 months; (10) Have an infection close to the position of the specified acupoints; (11) Have any serious physical illness (such as serious cardiovascular, lung, liver, and kidney diseases, etc.); (12) With alcohol or drug abuse/addiction; (13) Have participated in any clinical trial in the last three months; (14) With other conditions which makes them an unsuitable candidate for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMD-17; | — |
Secondary
| Measure | Time frame |
|---|---|
| ISI;MS-TSQ;MENQOL;KI;SRRS;APS;Meno-D;Sleep hygiene behavior checklist;HAMA;MGHASS;sex hormone test;AES;PSQI;SCSQ; | — |
Countries
China
Contacts
Public ContactZhang Wenjing
Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed