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

Z

Zan Wang

Status

Enrolling

Conditions

Insomnia

Treatments

Other: Intelligent Diagnostic and Treatment Model
Drug: Traditional treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT07357779
CBTI-V1

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Traditional treatment group
Sham Comparator group
Treatment:
Drug: Traditional treatment
Intelligent diagnosis and treatment group
Active Comparator group
Treatment:
Other: Intelligent Diagnostic and Treatment Model

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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