Software-delivered CBT-I for Insomnia Disorder
- Conditions
- Insomnia Disorder
- Registration Number
- NCT05747963
- Lead Sponsor
- Peking University Sixth Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 236
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The Change of Insomnia Severity from Baseline to Follow-up 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 Outcome Measures
Name Time Method Sleep Quality Baseline, post-intervention, follow-up (3 months after post-intervention) Pittsburgh Sleep Quality Index (PSQI) is used to assess overall sleep quality.
Insomnia Remission Baseline, post-intervention, follow-up (3 months after post-intervention) Insomnia remission was evaluated by a masked assessor using a semi-structured interview.
Insomnia Treatment Response Baseline, post-intervention, follow-up (3 months after post-intervention) Insomnia treatment response was defined by a decrease in ISI by at least 8 points.
Anxiety Baseline, post-intervention, follow-up (3 months after post-intervention) Generalized Anxiety Disorder Scale-7 (GAD-7) is used to evaluate the severity of anxiety.
Depression Baseline, post-intervention, follow-up (3 months after post-intervention) Patient Health Questionnaire-9 (PHQ-9) is used to evaluate the severity of depression.
Sleep Parameters Assessed by Sleep Diary Baseline, post-intervention, follow-up (3 months after post-intervention) Sleep diaries related parameters include time taken to fall asleep (sleep onset latency), wake after sleep onset, total sleep, total time in bed, and sleep efficiency.
Life Quality Baseline, post-intervention, follow-up (3 months after post-intervention) WHOQOL-BREF is used to evaluate the life quality.
Trial Locations
- Locations (5)
Peking University Sixth Hospital
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Shenzhen Kangning Hospital
🇨🇳Shenzhen, Guangdong, China
The Second Affiliated Hospital of AFMU
🇨🇳Xi'an, Shaanxi, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
Peking University Sixth Hospital🇨🇳Beijing, Beijing, China