InsomniaNCT07357779
Clinical Efficacy and Health Economic Evaluation of an Intelligent Diagnostic and Treatment Model
A study testing Intelligent Diagnostic and Treatment Model and Traditional treatment in people with Insomnia, run by Zan Wang at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Intelligent Diagnostic and Treatment Model and Traditional treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 404 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Clinical diagnosis of insomnia disorder; (2) Cooperate to complete the questionnaire surveys.
Who cannot join
- (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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Hospital of Jilin University
Changchun, Jilin, 130021
Yanan Zhang, MD, PhD, +86 15764399808, 2454318740@qq.com
About this study
Official title: 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
Read the 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.
- Conditions
- Insomnia
- Being tested
- Intelligent Diagnostic and Treatment Model, Traditional treatment
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent Diagnostic and Treatment ModelOther
Intelligent CBTI
Traditional treatmentDrug
sleep drug treatment
| Study group | Role | What they receive |
|---|---|---|
| Traditional treatment group | Sham comparator | Not described Receives: Drug: Traditional treatment |
| Intelligent diagnosis and treatment group | Active comparator | Not described Receives: Other: Intelligent Diagnostic and Treatment Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks and 3 months
Secondary outcomes (16)
Change in total sleep time (TST) measured by sleep diary
Measured: 6 weeks and 3 months
Change in sleep onset latency (SOL) measured by sleep diary
Measured: 6 weeks and 3 months
Change in wake after sleep onset (WASO) measured by sleep diary
Measured: 6 weeks and 3 months
Change in sleep efficiency (SE) measured by sleep diary
Measured: 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.
Measured: 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
Measured: 6 weeks and 3 months
the score of Pittsburgh Sleep Quality Index
The total score ranges from 0 to 21, and a higher score indicates poorer sleep quality. A score greater than 5 is commonly used as the cut point for poor sleep quality.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 weeks and 3 months
20-item Multidimensional Fatigue Inventory
The 20-item Multidimensional Fatigue Inventory is used to assess multidimensional fatigue. It consists of 20 items rated from 1 to 5. The total score ranges from 20 to 100, and a higher score indicates a higher level of fatigue.
Measured: 6 weeks and 3 months
the score of Epworth Sleepiness Scale
The total score ranges from 0 to 24, and a higher score indicates a higher level of daytime sleepiness. A score of 11 or greater is commonly used as the cut point for excessive daytime sleepiness.
Measured: 6 weeks and 3 months
the score of Hyperarousal Scale
The Hyperarousal Scale is used to assess cognitive, emotional, and behavioral hyperarousal. It consists of 26 items rated on a 4-point scale from 0 = not at all to 3 = extremely. The total score ranges from 0 to 78, and a higher score indicates a higher level of hyperarousal.
Measured: 6 weeks and 3 months
the score of Dysfunctional Beliefs and Attitudes about Sleep scale-30
The Dysfunctional Beliefs and Attitudes about Sleep scale-30 is used to assess maladaptive beliefs and attitudes related to sleep. It consists of 30 items, with each item rated from 0 to 100. The mean score ranges from 0 to 100, and a higher score indicates stronger dysfunctional beliefs and attitudes about sleep.
Measured: 6 weeks and 3 months
the score of 36-Item Short-Form Health Survey
The 36-Item Short-Form Health Survey is used to assess health-related quality of life. Domain scores range from 0 to 100, and higher scores indicate better health-related quality of life.
Measured: 6 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start20 Jan 2026
- Primary completion1 May 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zan Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zan Wang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357779
- Sponsor's protocol ID
- CBTI-V1
- Status last verified
- Jul 2026
- First submitted
- 4 Jan 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Health Economic Evaluation of an Intelligent Diagnostic and Treatment Model Based on Digital Cognitive Behavioral Therapy for Insomnia Disorder
- ClinicalTrials.gov ID
- NCT07357779
- Acronym / sponsor ID
- CBTI-V1
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- Zan WangUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional treatment group | Sham comparator | Drug: Traditional treatment |
| Intelligent diagnosis and treatment group | Active comparator | Other: Intelligent Diagnostic and Treatment Model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) Clinical diagnosis of insomnia disorder; (2) Cooperate to complete the questionnaire surveys.
Key exclusion criteria (1 listed)
- (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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intelligent Diagnostic and Treatment ModelIntelligent CBTI | Other | Intelligent diagnosis and treatment group |
| Traditional treatmentsleep drug treatment | Drug | Traditional treatment group |
Primary outcome
the score of Insomnia Severity Index scale
Time frame: 6 weeks and 3 months
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
16 secondary outcomes
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
the score of Epworth Sleepiness Scale
Time frame: 6 weeks and 3 months
the score of Hyperarousal Scale
Time frame: 6 weeks and 3 months
the score of Dysfunctional Beliefs and Attitudes about Sleep scale-30
Time frame: 6 weeks and 3 months
the score of 36-Item Short-Form Health Survey
Time frame: 6 weeks and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent Diagnostic and Treatment Model and Traditional treatment in people with Insomnia, run by Zan Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the score of Insomnia Severity Index scale (time frame: 6 weeks and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.