Software-delivered CBT-I for Insomnia Disorder

The goal of this prospective multicenter clinical trial is to evaluate the efficacy and safety of software-delivered cognitive behavioral therapy for insomnia (CBT-I) in Chinese patients with insomnia disorder (ID). The main questions it aims to answer are: (1) whether the software-delivered CBT-I is more effective than an online patient education (online-PE) at improving insomnia. (2) whether the software-delivered CBT-I is safe for treatment of insomnia symptoms.Participants will be randomized to receive (1) a software-delivered CBT-I using automated software called 'Ru-mian' (one kind of digital device expected to treat insomnia targeted for Chinese patients); (2) online patient education (online-PE) about sleep.Researchers will compare the efficacy of a software-delivered CBT-I program and an online sleep education control at improving insomnia symptoms and other psychological outcomes.

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 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.