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

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

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

Study Overview

• Status: Recruiting
• Conditions: Insomnia
• Intervention / Treatment: Drug: Traditional treatment; Other: Intelligent Diagnostic and Treatment Model

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Yanan Zhang, MD, PhD; Phone Number: +86 15764399808; Email: 2454318740@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Traditional treatment group	Drug: Traditional treatment; sleep drug treatment
Active Comparator: Intelligent diagnosis and treatment group	Other: Intelligent Diagnostic and Treatment Model; Intelligent CBTI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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
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 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 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 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 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in plasma corticotropin-releasing factor (CRF) level	Plasma corticotropin-releasing factor (CRF) concentration was measured as a biomarker of hypothalamic-pituitary-adrenal (HPA) axis activity. Higher levels indicate increased neuroendocrine stress response. Unit of Measure: pg/mL	6 weeks and 3 months
Change in plasma cortisol level	Plasma cortisol concentration was assessed as an indicator of hypothalamic-pituitary-adrenal (HPA) axis function. Higher levels reflect increased physiological stress response. Unit of Measure: μg/dL	6 weeks and 3 months
Change in serum interleukin-6 (IL-6) level	Serum interleukin-6 (IL-6) concentration was measured as a marker of systemic inflammation. Higher levels indicate greater inflammatory activity. Unit of Measure: pg/mL	6 weeks and 3 months
Change in serum brain-derived neurotrophic factor (BDNF) level	Serum brain-derived neurotrophic factor (BDNF) concentration was measured as a biomarker associated with neuroplasticity and neuronal function. Higher levels indicate enhanced neurotrophic activity. Unit of Measure: pg/mL	6 weeks and 3 months
Change in total sleep time (TST) measured by polysomnography		6 weeks and 3 months
Change in sleep onset latency (SOL) measured by polysomnography		6 weeks and 3 months
Change in wake after sleep onset (WASO) measured by polysomnography		6 weeks and 3 months

Collaborators and Investigators

• Sponsor: Zan Wang

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Actual): May 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 4, 2026
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: CBTI-V1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No