Software-delivered CBT-I for Insomnia Disorder

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 StatisticalManual 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 andcerebrovascular disease acute phase, etc.

• Current diagnosed neurological or mental illness (major depressive disorder, bipolardisorder, 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. orlater than 2 a.m., or usual waking (arising) time is earlier than 4 a.m. or laterthan 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 andmethod 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.