Software-delivered CBT-I for Insomnia Disorder

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Insomnia Disorder

Intervention / Treatment
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* Device: software-delivered CBT-I
* Other: online PE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, multicenter, parallel, randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: software-delivered CBT-I<br>Subjects in intervention group will receive a digital CBT-I for 6 weeks. The automated software incorporates all core elements of CBT-I, tailoring content based on each participant's reported baseline sleep function and sleep progress. | Device: software-delivered CBT-I<br>* 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.<br>|
| Active Comparator: online PE<br>Subjects in control group will receive information about insomnia and sleep health education content. | Other: online PE<br>* Subjects in the control group will receive non-tailored information about insomnia and sleep health education content using the Wechat Official Account.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change of Insomnia Severity from Baseline to Follow-up | 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. | Baseline, post-intervention, follow-up (3 months after post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Remission | Insomnia remission was evaluated by a masked assessor using a semi-structured interview. | Baseline, post-intervention, follow-up (3 months after post-intervention) | 
| Insomnia Treatment Response | Insomnia treatment response was defined by a decrease in ISI by at least 8 points. | Baseline, post-intervention, follow-up (3 months after post-intervention) | 
| Sleep Parameters Assessed by Sleep Diary | 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. | Baseline, post-intervention, follow-up (3 months after post-intervention) | 
| Sleep Quality | Pittsburgh Sleep Quality Index (PSQI) is used to assess overall sleep quality. | Baseline, post-intervention, follow-up (3 months after post-intervention) | 
| Depression | Patient Health Questionnaire-9 (PHQ-9) is used to evaluate the severity of depression. | Baseline, post-intervention, follow-up (3 months after post-intervention) | 
| Anxiety | Generalized Anxiety Disorder Scale-7 (GAD-7) is used to evaluate the severity of anxiety. | Baseline, post-intervention, follow-up (3 months after post-intervention) | 
| Life Quality | WHOQOL-BREF is used to evaluate the life quality. | Baseline, post-intervention, follow-up (3 months after post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia Disorder, Software-delivered CBT-I, Randomised Clinical Trial, Digital Therapy