Insomnia Disorder
Conditions
Keywords
Insomnia Disorder, Software-delivered CBT-I, Randomised Clinical Trial, Digital Therapy
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.
Interventions
DEVICEsoftware-delivered CBT-I
The automated software called 'resleep' incorporates all core elements of CBT-I: sleep restriction, stimulus control, cognitive therapy, relaxation techniques, and sleep hygiene and education, tailoring content based on each participant's reported baseline sleep function and sleep progress. The 6-week treatment includes 42 times of intervention.
OTHERonline PE
Subjects in the control group will receive non-tailored information about insomnia and sleep health education content using the Wechat Official Account.
Sponsors
Shenzhen Zeen Health Technology Co., Ltd.
Peking University First Hospital
Sichuan Provincial People's Hospital
The Second Affiliated Hospital of AFMU
Shenzhen Kangning Hospital
Peking University Sixth Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A prospective, multicenter, parallel, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Life Quality | Baseline, post-intervention, follow-up (3 months after post-intervention) | WHOQOL-BREF is used to evaluate the life quality. |
| Sleep Quality | Baseline, post-intervention, follow-up (3 months after post-intervention) | Pittsburgh Sleep Quality Index (PSQI) is used to assess overall sleep quality. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Baseline, post-intervention, follow-up (3 months after post-intervention) | Adverse events will be recorded throughout this trial for evaluating the safety of software. |
Countries
China
Outcome results
None listed