Intelligent app-based diagnosis and treatment program for insomnia
Clinical Efficacy and Health Economic Evaluation of an Intelligent Diagnostic and Treatment Model Based on Digital Cognitive Behavioral Therapy for Insomnia Disorder
NA · The First Hospital of Jilin University · NCT07357779
This trial will try an intelligent, app-delivered cognitive behavioral therapy program to help adults with insomnia sleep better and reduce treatment costs.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Hospital of Jilin University (other) |
| Locations | 1 site (Changchun, Jilin) |
| Trial ID | NCT07357779 on ClinicalTrials.gov |
What this trial studies
This interventional study compares an intelligent digital cognitive behavioral therapy for insomnia (dCBT-I) diagnostic-and-treatment model with traditional treatment at a single tertiary hospital. Adults with a clinical diagnosis of insomnia who can complete questionnaires are enrolled, while people with other primary sleep disorders, substance abuse, certain medications, or sleep problems secondary to organic disease are excluded. Participants receive either the intelligent dCBT-I pathway or usual care and complete clinical and health-economic outcome measures. The protocol focuses on both symptom improvement and cost-effectiveness of the digital approach.
Who should consider this trial
Good fit: Adults with a clinical diagnosis of insomnia who can cooperate with completing questionnaire surveys and who do not have other primary sleep disorders or excluded medication/substance use are ideal candidates.
Not a fit: People with other diagnosed sleep disorders (like obstructive sleep apnea, REM behavior disorder, or restless legs), sleep problems secondary to organic disease, current alcohol abuse, or use of excluded stimulants/medications are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could expand access to personalized CBT-I, improve sleep outcomes for patients, and lower overall treatment costs.
How similar studies have performed: Multiple trials have shown that internet-based CBT-I improves insomnia symptoms, although fully integrated intelligent diagnostic-and-treatment models with formal health-economic evaluation are less widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) Clinical diagnosis of insomnia disorder; (2) Cooperate to complete the questionnaire surveys. Exclusion Criteria: * (1) Current use of central nervous system stimulants; (2) Use of analgesics, theophylline preparations, steroid medications; (3) Alcohol abuse or regular alcohol intake; (4) Diagnosis of other sleep disorders (e.g., obstructive sleep apnea, rapid eye movement sleep behavior disorder, restless legs syndrome) ; (5) Sleep disorders secondary to organic diseases (e.g., epilepsy, diabetes, renal failure).
Where this trial is running
Changchun, Jilin
- the First Hospital of Jilin University — Changchun, Jilin, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Insomnia