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

NCT07357779 | Recruiting

• 1 other identifier: CBTI-V1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Insomnia

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (7)

• Change in plasma corticotropin-releasing factor (CRF) level

  6 weeks and 3 months

• Change in plasma cortisol level

  6 weeks and 3 months

• Change in serum interleukin-6 (IL-6) level

  6 weeks and 3 months

• Change in serum brain-derived neurotrophic factor (BDNF) level

  6 weeks and 3 months

• Change in total sleep time (TST) measured by polysomnography

  6 weeks and 3 months

Study Arms (2)

Traditional treatment group

SHAM COMPARATOR

Drug: Traditional treatment

Intelligent diagnosis and treatment group

ACTIVE COMPARATOR

Other: Intelligent Diagnostic and Treatment Model

Interventions

Intelligent Diagnostic and Treatment Model OTHER

Intelligent CBTI

Intelligent diagnosis and treatment group

Traditional treatment DRUG

sleep drug treatment

Traditional treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Clinical diagnosis of insomnia disorder; (2) Cooperate to complete the questionnaire surveys.

You may not qualify if:

• (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).

Sponsors & Collaborators

• Zan Wang: lead

Study Sites (1)

the First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sleep Center Director

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 22, 2026
• Study Start: March 1, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

CN (1)