the First Hospital of Jilin University
Changchun, Jilin, 130021, China
Location status: Recruiting
NCT Number: NCT07357779
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Changchun, Jilin, 130021, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intelligent CBTI
sleep drug treatment
Time frame: 6 weeks and 3 months
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
Time frame: 6 weeks and 3 months
Time frame: 6 weeks and 3 months
Time frame: 6 weeks and 3 months
Time frame: 6 weeks and 3 months
Time frame: 6 weeks and 3 months
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.
Time frame: 6 weeks and 3 months
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
Time frame: 6 weeks and 3 months
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.
Time frame: 6 weeks and 3 months
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
Time frame: 6 weeks and 3 months
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
Time frame: 6 weeks and 3 months
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
Time frame: 6 weeks and 3 months
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
Time frame: 6 weeks and 3 months
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.
Time frame: 6 weeks and 3 months
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.
Time frame: 6 weeks and 3 months
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.
Time frame: 6 weeks and 3 months
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.
Time frame: 6 weeks and 3 months
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.
Zan Wang
Other
Clinical Efficacy and Health Economic Evaluation of an Intelligent Diagnostic and Treatment Model Based on Digital Cognitive Behavioral Therapy for Insomnia Disorder
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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