A Prospective, Multicenter, Randomized Clinical Trial for Evaluating the Safety and Efficacy of Software-delivered Cognitive Behavioral Therapy for Insomnia in Patients With Insomnia Disorder.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Insomnia Disorder
- Sponsor
- Peking University Sixth Hospital
- Enrollment
- 236
- Locations
- 5
- Primary Endpoint
- The Change of Insomnia Severity from Baseline to Follow-up
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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 'resleep' (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.
Investigators
Hongqiang Sun
Professor
Peking University Sixth Hospital
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;
Outcomes
Primary Outcomes
The Change of Insomnia Severity from Baseline to Follow-up
Time Frame: Baseline, post-intervention, follow-up (3 months after post-intervention)
The insomnia severity is assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire well validated in insomnia research in multiple patient populations. The change of ISI scores from baseline to follow-up is the primary outcome.
Secondary Outcomes
- Sleep Quality(Baseline, post-intervention, follow-up (3 months after post-intervention))
- Insomnia Remission(Baseline, post-intervention, follow-up (3 months after post-intervention))
- Insomnia Treatment Response(Baseline, post-intervention, follow-up (3 months after post-intervention))
- Anxiety(Baseline, post-intervention, follow-up (3 months after post-intervention))
- Depression(Baseline, post-intervention, follow-up (3 months after post-intervention))
- Sleep Parameters Assessed by Sleep Diary(Baseline, post-intervention, follow-up (3 months after post-intervention))
- Life Quality(Baseline, post-intervention, follow-up (3 months after post-intervention))