Software-delivered CBT-I for Insomnia Disorder
Insomnia Disorder
About this trial
This is an interventional treatment trial for Insomnia Disorder focused on measuring Insomnia Disorder, Software-delivered CBT-I, Randomised Clinical Trial, Digital Therapy
Eligibility Criteria
Inclusion Criteria: Aged ≥18 years old, no gender limitation; Own a mobile-phone, access the Internet, and be skilled in using software; Meet the diagnostic criteria of insomnia disorder in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5); Insomnia symptoms appear at least 3 nights per week and last for at least 3 months; ISI scores ≥ 12 ; Volunteer to participate in this experiment and sign a written informed consent. Exclusion Criteria: Generalized Anxiety Disorder Scale-7 (GAD-7) scores ≥ 15; Patients Health Questionnaire-9 (PHQ-9) scores ≥ 20; Current thoughts of suicide or self-injury (defined as PHQ-9 9th item score ≥ 1); Confirmed physical diseases that may affect sleep, such as congestive heart failure, chronic obstructive pulmonary disease acute phase, cardiovascular and cerebrovascular disease acute phase, etc. Current diagnosed neurological or mental illness (major depressive disorder, bipolar disorder, epilepsy, schizophrenia, etc.) that may affect sleep; Diagnoses of other untreated sleep disorders, such as obstructive sleep apnea, restless leg syndrome (RLS); Usual bedtime (when the subject attempts to fall asleep) is earlier than 8 p.m. or later than 2 a.m., or usual waking (arising) time is earlier than 4 a.m. or later than 10 a.m. Alcohol or drug abusers (other than nicotine dependence) in the past year; Pregnant or lactating women; Undergoing systematic psychotherapy within the past 3 months; Undergoing other cognitive behavioral therapy for sleep disorders; Unstable usage of medication regimens that affect sleep (changes in type, dosage and method of use within the past 1 month); Night shift workers, travelers across time zones; Subjects who have not responded to previous CBT-I; Other conditions deemed unsuitable for clinical trials by the investigator.
Sites / Locations
- Peking University Sixth HospitalRecruiting
- Peking University First HospitalRecruiting
- Shenzhen Kangning HospitalRecruiting
- The Second Affiliated Hospital of AFMURecruiting
- Sichuan Provincial People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
software-delivered CBT-I
online PE
Subjects in intervention group will receive a digital CBT-I for 6 weeks. The automated software incorporates all core elements of CBT-I, tailoring content based on each participant's reported baseline sleep function and sleep progress.
Subjects in control group will receive information about insomnia and sleep health education content.