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The purpose of this study is to evaluate the clinical and cost-effectiveness of an intelligent therapy based on digital cognitive behavioral therapy for insomnia disorders
Insomnia is a highly prevalent and distressing disorder, yet access to its first-line treatment, cognitive behavioral therapy for insomnia (CBT-I) remains highly limited. Therefore, providing accessible and personalized CBT-I is pivotal in its application. With the widespread development of the internet and mobile application devices, digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) has opened new avenues for the diagnosis and treatment of insomnia disorder. Studies have explored internet-based, self-administered CBT-I treatment models, which have increased access to effective psychological therapy for patients with insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional treatment group | Sham Comparator |
| |
| Intelligent diagnosis and treatment group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intelligent Diagnostic and Treatment Model | Other | Intelligent CBTI |
|
| Measure | Description | Time Frame |
|---|---|---|
| the score of Insomnia Severity Index scale | The total score ranges from 0 to 28, and a higher score indicates higher levels of insomnia severity. A score of 8 or greater is the cut point for clinically possible insomnia | 6 weeks and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total sleep time (TST) measured by sleep diary | 6 weeks and 3 months | |
| Change in sleep onset latency (SOL) measured by sleep diary | 6 weeks and 3 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130021 | China |
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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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| Traditional treatment | Drug | sleep drug treatment |
|
| Change in wake after sleep onset (WASO) measured by sleep diary |
| 6 weeks and 3 months |
| Change in sleep efficiency (SE) measured by sleep diary | 6 weeks and 3 months |
| the value of indirect costs | Indirect costs refer to productivity losses associated with insomnia disorder and treatment-seeking, including work absence, reduced productivity while working, overall work productivity loss, activity impairment, and productivity loss among family caregivers or accompanying persons. Costs will be estimated in Chinese yuan using the human capital approach. | 6 weeks and 3 months |
| the value of direct medical costs | Direct medical costs refer to healthcare expenditures incurred by patients during visits to medical institutions, including consultation fees, diagnostic and examination costs, medication expenses, and hospitalization costs | 6 weeks and 3 months |
| the score of Pittsburgh Sleep Quality Index | The total score ranges from 0 to 21, and a higher score indicates poorer sleep quality. A score greater than 5 is commonly used as the cut point for poor sleep quality. | 6 weeks and 3 months |
| the value of Work Productivity and Activity Impairment: General Health | The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire assesses the impact of health problems on work productivity and daily activities over the past seven days, including absenteeism, presenteeism, overall work productivity loss, and activity impairment. Scores are expressed as percentages, with higher scores indicating greater impairment | 6 weeks and 3 months |
| the value of European Quality of Life Five Dimension | The European Quality of Life Five Dimension is a standardized measure of health-related quality of life assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher scores indicate better quality of life | 6 weeks and 3 months |
| the score of Patient Health Questionnaire-9 scale | The total score ranges from 0 to 27, and a higher score indicates higher levels of depression symptoms. A score of 10 or greater is the cut point for clinically possible depression symptom | 6 weeks and 3 months |
| the score of 7-item Generalized Anxiety Disorder scale | The total score ranges from 0 to 21, and a higher score indicates higher levels of anxiety symptoms. A score of 10 or greater is the cut point for clinically possible anxiety | 6 weeks and 3 months |
| 20-item Multidimensional Fatigue Inventory | The 20-item Multidimensional Fatigue Inventory is used to assess multidimensional fatigue. It consists of 20 items rated from 1 to 5. The total score ranges from 20 to 100, and a higher score indicates a higher level of fatigue. | 6 weeks and 3 months |
| the score of Epworth Sleepiness Scale | The total score ranges from 0 to 24, and a higher score indicates a higher level of daytime sleepiness. A score of 11 or greater is commonly used as the cut point for excessive daytime sleepiness. | 6 weeks and 3 months |
| the score of Hyperarousal Scale | The Hyperarousal Scale is used to assess cognitive, emotional, and behavioral hyperarousal. It consists of 26 items rated on a 4-point scale from 0 = not at all to 3 = extremely. The total score ranges from 0 to 78, and a higher score indicates a higher level of hyperarousal. | 6 weeks and 3 months |
| the score of Dysfunctional Beliefs and Attitudes about Sleep scale-30 | The Dysfunctional Beliefs and Attitudes about Sleep scale-30 is used to assess maladaptive beliefs and attitudes related to sleep. It consists of 30 items, with each item rated from 0 to 100. The mean score ranges from 0 to 100, and a higher score indicates stronger dysfunctional beliefs and attitudes about sleep. | 6 weeks and 3 months |
| the score of 36-Item Short-Form Health Survey | The 36-Item Short-Form Health Survey is used to assess health-related quality of life. Domain scores range from 0 to 100, and higher scores indicate better health-related quality of life. | 6 weeks and 3 months |
| D001523 |
| Mental Disorders |