Insomnia
Conditions
Brief summary
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
Detailed description
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.
Interventions
OTHERIntelligent Diagnostic and Treatment Model
Intelligent CBTI
DRUGTraditional treatment
sleep drug treatment
Sponsors
Zan Wang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* (1) Clinical diagnosis of insomnia disorder; (2) Cooperate to complete the questionnaire surveys.
Exclusion criteria
* (1) Current use of central nervous system stimulants; (2) Use of analgesics, theophylline preparations, steroid medications; (3) Alcohol abuse or regular alcohol intake; (4) Diagnosis of other sleep disorders (e.g., obstructive sleep apnea, rapid eye movement sleep behavior disorder, restless legs syndrome) ; (5) Sleep disorders secondary to organic diseases (e.g., epilepsy, diabetes, renal failure).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the score of Insomnia Severity Index scale | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | 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. |
| the value of direct medical costs | 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 |
| the score of Pittsburgh Sleep Quality Index | 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. |
| the value of Work Productivity and Activity Impairment: General Health | 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 |
| the value of European Quality of Life Five Dimension | 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 |
| the score of Patient Health Questionnaire-9 scale | 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 |
| the score of 7-item Generalized Anxiety Disorder scale | 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 |
| 20-item Multidimensional Fatigue Inventory | 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. |
| the score of Epworth Sleepiness Scale | 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. |
| the score of Hyperarousal Scale | 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. |
| the score of Dysfunctional Beliefs and Attitudes about Sleep scale-30 | 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. |
| the score of 36-Item Short-Form Health Survey | 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. |
Countries
China
Outcome results
None listed