CBTI InsomniaCBT-INCT07730593
CBT-I for the Patients With Chronic Insomnia in China
A study testing cognitive behavioral therapy for insomnia in people with CBTI Insomnia, run by Peking University People's Hospital at 1 site in China.
Trial summary
Insomnia is one of major public health problems.This study aimed to assess benefits and problems of CBT-I for chronic insomnia based on the influence of Chinese tradition and culture. Read more about this study
- Who is it for?
- Ages 37 to 76 years
- Conditions the study is for
- CBTI Insomnia
- What is being tested?
- cognitive behavioral therapy for insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 37 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- were diagnosed as chronic insomnia based on the third edition of the International Classification of Sleep Disorders(ICSD-3) ;
- agree to participate in this study and sign informed consent.
Who cannot join
- Patient Health Questionnaire(PHQ-9)> 15 points;
- hallucinations or taking antipsychotic medication at the time of evaluation;
- Insomnia due to drug side effects, other illnesses or co-morbidities;
- dementia according to 4th edition of the Diagnostic and Statistical Manual of Mental Disorders;
- severe physical illness or severe abnormalities in heart, liver, kidney and thyroid function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of CBT-I for the Patients With Chronic Insomnia in China
Insomnia is one of major public health problems.This study aimed to assess benefits and problems of CBT-I for chronic insomnia based on the influence of Chinese tradition and culture.
Read the detailed description
Participants with chronic insomnia were enrolled to a 6 weeks CBT-I program . At baseline and follow-up to week 12, all patients were assessed using polysomnography (PSG), sleep diary and subjective scales.
- Conditions
- CBTI Insomnia
- Being tested
- cognitive behavioral therapy for insomnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapy for insomniaBehavioural
CBT-I has been developed as a structured clinical practice, which integrates a constellation of treatment components, such as stimulus control, sleep restriction，relaxation therapy, cognitive therapy and sleep hygiene education
| Study group | Role | What they receive |
|---|---|---|
| A pilot study of CBT-I for the patients with chronic insomnia in China | Experimental | Participants with chronic insomnia were enrolled to a 6 weeks CBT-I program. Receives: Behavioral: cognitive behavioral therapy for insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Polysomnography (PSG) parameters - TST
total sleep time
Measured: 6 weeks.
Secondary outcomes (21)
Change of Polysomnography (PSG) parameters-SOL
sleep onset latency (SOL)
Measured: 6 weeks
Change of Polysomnography (PSG) parameters-TIB
time in bed (TlB)
Measured: 6 weeks
Change of Polysomnography (PSG) parameters-SE
sleep efficiency(SE)
Measured: 6 weeks
Change of Polysomnography (PSG) parameters-REM latency
Rapid Eye Movement (REM)
Measured: 6 weeks
Change of Polysomnography (PSG) parameters- Stage R
Measured: 6 weeks
Change of Polysomnography (PSG) parameters-Stage N1
Measured: 6 weeks
Change of Polysomnography (PSG) parameters-Stage N2
Measured: 6 weeks
Change of Polysomnography (PSG) parameters-Stage N3
Measured: 6 weeks
Change of Polysomnography (PSG) parameters-Arousal
Measured: 6 weeks
Change of Polysomnography (PSG) parameters-SpO2 mean
Measured: 6 weeks
Change of Polysomnography (PSG) parameters-AHI
apnea-hypopnea index (AHI)
Measured: 6 weeks
Change of sleep diary parameters-SOL
sleep onset latency (SOL)
Measured: 6 weeks
Change of sleep diary parameters-TST
total sleep time (TST)
Measured: 6 weeks
Change of sleep diary parameters-TIB
time in bed (TlB)
Measured: 6 weeks
Change of sleep diary parameters-SE
sleep efficiency(SE)
Measured: 6 weeks
Change of sleep diary parameters-NAD
number of awakenings during the night (NAD)
Measured: 6 weeks
Change of sleep diary parameters-WASO
wake time after sleep onset (WASO)
Measured: 6 weeks
Change of lSl
insomnia severity index. The total score ranges from 0 to 28, with higher scores indicating more severe insomnia symptoms. A decrease from baseline indicates improvement.
Measured: 12 weeks
Change of PSQl
Pittsburg sleep quality index. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A decrease from baseline indicates improvement.
Measured: 12 weeks
Change of SAS
Self-Rating Anxiety Scale. The index score ranges from 20 to 80, with higher scores indicating more severe anxiety symptoms. A decrease from baseline indicates improvement.
Measured: 12 weeks
Change of SDS
Self-rating depression scale. The index score ranges from 20 to 80, with higher scores indicating more severe depressive symptoms. A decrease from baseline indicates improvement.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Jul 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CBTI InsomniaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huo Yang, Peking University People's Hospital
- Investigators
- huailian guo, Dr,, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730593
- Sponsor's protocol ID
- PekingUPH2018
- Acronym
- CBT-I
- Status last verified
- Feb 2025
- First submitted
- 8 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of CBT-I for the Patients With Chronic Insomnia in China
- ClinicalTrials.gov ID
- NCT07730593
- Acronym / sponsor ID
- CBT-I / PekingUPH2018
- Conditions
- CBTI Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 28 Jul 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.
Insomnia is one of major public health problems.This study aimed to assess benefits and problems of CBT-I for chronic insomnia based on the influence of Chinese tradition and culture.
Detailed description
Participants with chronic insomnia were enrolled to a 6 weeks CBT-I program . At baseline and follow-up to week 12, all patients were assessed using polysomnography (PSG), sleep diary and subjective scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A pilot study of CBT-I for the patients with chronic insomnia in China | Experimental | Behavioral: cognitive behavioral therapy for insomniaParticipants with chronic insomnia were enrolled to a 6 weeks CBT-I program. |
Who may qualify
- Ages
- 37 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- were diagnosed as chronic insomnia based on the third edition of the International Classification of Sleep Disorders(ICSD-3) ;
- agree to participate in this study and sign informed consent.
Key exclusion criteria (5 listed)
- Patient Health Questionnaire(PHQ-9)> 15 points;
- hallucinations or taking antipsychotic medication at the time of evaluation;
- Insomnia due to drug side effects, other illnesses or co-morbidities;
- dementia according to 4th edition of the Diagnostic and Statistical Manual of Mental Disorders;
- severe physical illness or severe abnormalities in heart, liver, kidney and thyroid function.
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 |
|---|---|---|
| cognitive behavioral therapy for insomniaCBT-I has been developed as a structured clinical practice, which integrates a constellation of treatment components, such as stimulus control, sleep restriction，relaxation therapy, cognitive therapy and sleep hygiene education | Behavioural | A pilot study of CBT-I for the patients with chronic insomnia in China |
Primary outcome
Change of Polysomnography (PSG) parameters - TST
Time frame: 6 weeks.
total sleep time
21 secondary outcomes
Change of Polysomnography (PSG) parameters-SOL
Time frame: 6 weeks
Change of Polysomnography (PSG) parameters-TIB
Time frame: 6 weeks
Change of Polysomnography (PSG) parameters-SE
Time frame: 6 weeks
Change of Polysomnography (PSG) parameters-REM latency
Time frame: 6 weeks
Change of Polysomnography (PSG) parameters- Stage R
Time frame: 6 weeks
Change of Polysomnography (PSG) parameters-Stage N1
Time frame: 6 weeks
Change of Polysomnography (PSG) parameters-Stage N2
Time frame: 6 weeks
Change of Polysomnography (PSG) parameters-Stage N3
Time frame: 6 weeks
Change of Polysomnography (PSG) parameters-Arousal
Time frame: 6 weeks
Change of Polysomnography (PSG) parameters-SpO2 mean
Time frame: 6 weeks
Change of Polysomnography (PSG) parameters-AHI
Time frame: 6 weeks
Change of sleep diary parameters-SOL
Time frame: 6 weeks
Change of sleep diary parameters-TST
Time frame: 6 weeks
Change of sleep diary parameters-TIB
Time frame: 6 weeks
Change of sleep diary parameters-SE
Time frame: 6 weeks
Change of sleep diary parameters-NAD
Time frame: 6 weeks
Change of sleep diary parameters-WASO
Time frame: 6 weeks
Change of lSl
Time frame: 12 weeks
Change of PSQl
Time frame: 12 weeks
Change of SAS
Time frame: 12 weeks
Change of SDS
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
huailian guo, Dr, study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral therapy for insomnia in people with CBTI Insomnia, run by Peking University People's Hospital 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 28 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Polysomnography (PSG) parameters - TST (time frame: 6 weeks.). 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 28 Jul 2026.