Subtyping of Insomnia Disorders Based on Multidimensional Features
Not Applicable
Recruiting
- Conditions
- Insomnia Disorder
- Interventions
- Behavioral: Cognitive Behavioral Therapy for Insomnia
- Registration Number
- NCT05985512
- Lead Sponsor
- Shanghai Mental Health Center
- Brief Summary
Based on real world and focusing on patients with chronic sleep disorders, this study conducts a data-driven subtyping research on the clinical symptoms, polysomnography, near-infrared scanning, molecular genetics, and other characteristics of chronic insomnia disorders. It constructs a multimodal therapeutic outcome prediction model, providing a basis for personalized interventions for chronic insomnia disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 216
Inclusion Criteria
- Aged between 18 and 65 years, regardless of gender;
- Currently meeting the diagnostic criteria for insomnia disorder according to the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- Pittsburgh Sleep Quality Index (PSQI) total score ≥ 10;
- Sufficient level of education and comprehension to complete the required examinations and assessments for this study;
- Voluntarily participating in this research and signing the informed consent form.
Exclusion Criteria
- Currently diagnosed with other sleep disorders (sleep-related breathing disorders, periodic limb movement disorder, parasomnias, central disorders of hypersomnolence, circadian rhythm sleep-wake disorders, etc.);
- Currently diagnosed with organic brain diseases (epilepsy, cerebrovascular disease, etc.) or other organic diseases;
- Patients with a history of or currently diagnosed with bipolar and related disorders, obsessive-compulsive and related disorders, schizophrenia spectrum and other psychotic disorders, trauma and stressor-related disorders, dissociative disorders, or eating disorders;
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
- Insomnia caused by alcohol or substance abuse;
- High suicide risk, with HAMD-17 suicide factor score > 2;
- Inability to cooperate with near-infrared examinations and polysomnography due to physical conditions such as head injury, etc.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Insomnia Disorder Cognitive Behavioral Therapy for Insomnia Patients with insomnia disorder
- Primary Outcome Measures
Name Time Method polysomnography the end of the eighth week change in total sleep time recorded by polysomnography
PSQI the end of the 24th, 36th, 48th week change in total sleep time according to PSQI scale
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shanghai Mental Health Center
🇨🇳Shanghai, Shanghai, China