Postmenopausal insomnia
Conditions
Interventions
Experimental group:Fixed treatment protocol (medication)+Digital Cognitive Behavioral Therapy (dCBT).
Control group:Fixed treatment protocol (medication)+Sleep Health Education Group
Sponsors
Beijing Shijitan Hospital, Capital Medical University
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1: Women aged 40-60 years who met the reproductive aging stage +10 perimenopausal and postmenopausal criteria 2. Did not take any chemical or traditional Chinese medicine to improve sleep symptoms. See the medication list for details 3: Modified Kupperman scale score >=6 points 4: No hormone therapy within 1 month, or continuous hormone therapy for more than 3 months 5: Meets the DSM-5 diagnostic criteria for insomnia disorder: (1) Patients complained that they were not satisfied with the quality or length of sleep. Symptoms included: inability to fall asleep, waking up early, and difficulty maintaining a stable sleep (frequent awakenings at night and difficulty falling back to sleep after waking up). (2) Insomnia disorder leads to obvious clinical symptoms or impaired social, occupational, educational, and behavioral functions (3) The frequency of the above symptoms was more than 3 times per week (4) The above symptoms lasted for at least 3 months (5) Adequate sleep opportunities and good sleep environment (6) These symptoms cannot be explained by other sleep-wake disorders (e.g., narcolepsy, respiratory-related sleep disorders, circadian rhythm sleep disorders, parasomnia). (7) Physical effects not caused by drugs or substances (e.g., drug abuse) (8) Insomnia symptoms are not secondary to a physical or mental disorder 6: Sleep severity index (ISI) >=7 7: Pittsburgh sleep Quality Index > 5 points 8: Junior high school or above, can use mobile phones and other devices to complete the operation of dCBTI
Exclusion criteria
Exclusion criteria: 1: Insomnia disorder caused by organic diseases. 2: Insomnia secondary to other psychiatric disorders such as depressive disorder, bipolar disorder, schizophrenia, etc. 3: Insomnia disorder caused by psychoactive substance or alcohol dependence. 4: Patients working in shift schedules. 5: Women who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index score;Modified Kupperman Index (KI) score;Dysfunctional Beliefs and Attitudes about Sleep Scale-16(DBAS-16);Symptom Checklist-90(SCL-90);Polysomnography (PSG) Monitoring;Measurement of Reproductive Hormone Levels;Sleep Perception Index ; | — |
Countries
China
Contacts
Public ContactBai Wenpei
Beijing Shijitan Hospital, Capital Medical University
Outcome results
None listed