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NCT Number: NCT07357779

Clinical Efficacy and Health Economic Evaluation of an Intelligent Diagnostic and Treatment Model

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location status: Recruiting

Location contact

Yanan Zhang, MD, PhD

CONTACT

[email protected]

+86 15764399808

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Intelligent Diagnostic and Treatment Model

Other

Intelligent CBTI

Traditional treatment

Drug

sleep drug treatment

Primary outcomes

  1. the score of Insomnia Severity Index scale

    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

Secondary outcomes

  1. Change in total sleep time (TST) measured by sleep diary

    Time frame: 6 weeks and 3 months

  2. Change in sleep onset latency (SOL) measured by sleep diary

    Time frame: 6 weeks and 3 months

  3. Change in wake after sleep onset (WASO) measured by sleep diary

    Time frame: 6 weeks and 3 months

  4. Change in sleep efficiency (SE) measured by sleep diary

    Time frame: 6 weeks and 3 months

  5. the value of indirect costs

    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.

  6. the value of direct medical costs

    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

  7. the score of Pittsburgh Sleep Quality Index

    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.

  8. the value of Work Productivity and Activity Impairment: General Health

    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

  9. the value of European Quality of Life Five Dimension

    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

  10. the score of Patient Health Questionnaire-9 scale

    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

  11. the score of 7-item Generalized Anxiety Disorder scale

    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

  12. 20-item Multidimensional Fatigue Inventory

    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.

  13. the score of Epworth Sleepiness Scale

    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.

  14. the score of Hyperarousal Scale

    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.

  15. the score of Dysfunctional Beliefs and Attitudes about Sleep scale-30

    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.

  16. the score of 36-Item Short-Form Health Survey

    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.

Sponsors and collaborators

Lead sponsor

Zan Wang

Other

Registry information

Official study title

Clinical Efficacy and Health Economic Evaluation of an Intelligent Diagnostic and Treatment Model Based on Digital Cognitive Behavioral Therapy for Insomnia Disorder

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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