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Recruiting NCT07357779

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

No phase Interventional Insomnia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intelligent Diagnostic and Treatment Model, Traditional treatment.
Who it may be relevant to
Registry conditions: Insomnia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Other Intelligent Diagnostic and Treatment Model
    Intelligent CBTI
  • Drug Traditional treatment
    sleep drug treatment

Primary outcome measures

  • the score of Insomnia Severity Index scale [Time frame: 6 weeks and 3 months]
Secondary outcome measures (12)
  • Change in total sleep time (TST) measured by sleep diary [Time frame: 6 weeks and 3 months]
  • Change in sleep onset latency (SOL) measured by sleep diary [Time frame: 6 weeks and 3 months]
  • Change in wake after sleep onset (WASO) measured by sleep diary [Time frame: 6 weeks and 3 months]
  • Change in sleep efficiency (SE) measured by sleep diary [Time frame: 6 weeks and 3 months]
  • the value of indirect costs [Time frame: 6 weeks and 3 months]
  • the value of direct medical costs [Time frame: 6 weeks and 3 months]
  • the score of Pittsburgh Sleep Quality Index [Time frame: 6 weeks and 3 months]
  • the value of Work Productivity and Activity Impairment: General Health [Time frame: 6 weeks and 3 months]
  • the value of European Quality of Life Five Dimension [Time frame: 6 weeks and 3 months]
  • the score of Patient Health Questionnaire-9 scale [Time frame: 6 weeks and 3 months]
  • the score of 7-item Generalized Anxiety Disorder scale [Time frame: 6 weeks and 3 months]
  • 20-item Multidimensional Fatigue Inventory [Time frame: 6 weeks and 3 months]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • the First Hospital of Jilin University — Changchun

Identifiers

NCT: NCT07357779 · CBTI-V1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗