Insomnia disorder with sedentary behavior (including chronic insomnia disorder and short-term insomnia disorder)
Conditions
Interventions
eCBTI group:e-aid Cognitive Behavioral Therapy for Insomnia
Sedentary interruption combined with eCBTI group:sedentary interruption combined with e-aid Cognitive Behavioral Therapy for Insomnia
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Meet diagnostic criteria for short-term insomnia disorder and chronic insomnia disorder in accordance with ICSD-3-TR; 2.Aged 18 years or older; 3.Able to understand and comply with the study protocol; 4.Able to provide written informed consent online; 5.Own and know how to use smart terminals such as smartphones, tablets and computers; 6.Able to wear a Huawei smart watch; 7.Self-reported total daily sedentary time = 5 hours and insufficient exercise (<150 minutes of weekly moderate to vigorous physical activity [MVPA]) in the past 6 months; 8.Ambulatory and independent in activities of daily living;
Exclusion criteria
Exclusion criteria: 1.Diagnosed and untreated physical illnesses, mental disorders, and/or other sleep disorders other than insomnia disorder; 2.Currently receiving any psychotherapy targeting insomnia disorder; 3.Shift workers, regular night shift workers, frequent trans-timezone travelers (e.g., airline crew), and those with physically active occupations (e.g., athletes, sports coaches); 4.Stop-Bang score >= 3; 5.Past history of substance abuse such as drug use or alcohol dependence; 6.Past history of organic brain diseases; 7.Pregnant or breastfeeding women; 8.Use of antibiotics, probiotics, or other biological agents within one month before enrollment; 9.Confirmed bacterial, fungal, or viral infection; 10.Have contraindications to physical activity (e.g., severe arthritis, muscle, joint or tendon injuries, etc.);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in insomnia severity (ISI score) from baseline after 4 weeks of intervention.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in daytime sleepiness (ESS score) from baseline after 2 weeks, 4 weeks and 3 months of intervention;Change in gut microbiota from baseline after 4 weeks and 3 months of intervention;Change in insomnia severity (ISI score) from baseline after 2 weeks and 3 months of intervention;Changes in sleep onset time, sleep efficiency, sleep latency, total sleep time, sleep regularity index and arousal index from baseline after 4 weeks and 3 months of intervention;Changes in depressive and anxiety symptoms (PHQ-9, GAD-7 scores) from baseline after 2 weeks, 4 weeks and 3 months of intervention;Changes in cellular inflammatory factors (IL-1ß, TNF-a) from baseline after 4 weeks and 3 months of intervention;Stratified by type of insomnia disorder (STID and CID), change in insomnia severity (ISI score) from baseline after 2 weeks, 4 weeks and 3 months of intervention;Change in quality of life (SF-12 score) from baseline after 2 weeks, 4 weeks and 3 months of intervention;Change in fatigue level (FS-14 score) from baseline after 2 weeks, 4 weeks and 3 months of intervention;Change in neurophysiological indicators (ERP) from baseline after 4 weeks and 3 months of intervention;Changes in cognitive task performance (PVT, n-back, GO/NO-GO) from baseline after 4 weeks and 3 months of intervention; | — |
Countries
China
Contacts
Public ContactBin Zhang
Southern Medical University Southern Hospital
Outcome results
None listed