Clinical Efficacy and Health Economic Evaluation of an Intelligent Diagnostic and Treatment Model
ConditionInsomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZan Wang
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(1) Clinical diagnosis of insomnia disorder; (2) Cooperate to complete the questionnaire surveys.
Disqualifiers
(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
Design model
Parallel
Treatments tested in this trial
Intelligent Diagnostic and Treatment Model
Other interventionIntelligent CBTI
Traditional treatment
Drugsleep drug treatment
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Traditional treatment groupSham comparator 1 intervention
Group B: Intelligent diagnosis and treatment groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
6 weeks and 3 months2
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
Time frame
6 weeks and 3 months3
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
Time frame
6 weeks and 3 months4
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
Time frame
6 weeks and 3 monthsSecondary outcomes
1
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
Time frame
6 weeks and 3 months2
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
Time frame
6 weeks and 3 months3
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
Time frame
6 weeks and 3 months4
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
Time frame
6 weeks and 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zan Wang
Lead sponsor
The First Hospital of Jilin University
Sponsor institution
Source ClinicalTrials.gov