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| Name | Class |
|---|---|
| Shenzhen Zeen Health Technology Co., Ltd. | UNKNOWN |
| Peking University First Hospital | OTHER |
| Sichuan Provincial People's Hospital | OTHER |
| The Second Affiliated Hospital of AFMU |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| software-delivered CBT-I | Experimental | 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. |
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| online PE | Active Comparator | Subjects in control group will receive information about insomnia and sleep health education content. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| software-delivered CBT-I | Device | 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. |
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse events will be recorded throughout this trial for evaluating the safety of software. | Baseline, post-intervention, follow-up (3 months after post-intervention) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Sixth Hospital | Beijing | Beijing Municipality | 100191 | China | ||
| Peking University First Hospital |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| UNKNOWN |
| Shenzhen Kangning Hospital | OTHER |
A prospective, multicenter, parallel, randomized controlled trial
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| online PE | Other | Subjects in the control group will receive non-tailored information about insomnia and sleep health education content using the Wechat Official Account. |
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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) |
| Beijing |
| Beijing Municipality |
| 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 |
| D001523 |
| Mental Disorders |