Peking University People's Hospital
Beijing, China
Completed
NCT Number: NCT07730593
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.
Completed
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Notify MeKey information
Conditions
Age range
37 year–76 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Treatment and study plan
Cognitive Behavioral Therapy for Insomnia
BehavioralCBT-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
Primary outcomes
-
Change of Polysomnography (PSG) parameters - TST
Time frame: 6 weeks.
total sleep time
Secondary outcomes
-
Change of Polysomnography (PSG) parameters-SOL
Time frame: 6 weeks
sleep onset latency (SOL)
-
Change of Polysomnography (PSG) parameters-TIB
Time frame: 6 weeks
time in bed (TlB)
-
Change of Polysomnography (PSG) parameters-SE
Time frame: 6 weeks
sleep efficiency(SE)
-
Change of Polysomnography (PSG) parameters-REM latency
Time frame: 6 weeks
Rapid Eye Movement (REM)
-
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
apnea-hypopnea index (AHI)
-
Change of sleep diary parameters-SOL
Time frame: 6 weeks
sleep onset latency (SOL)
-
Change of sleep diary parameters-TST
Time frame: 6 weeks
total sleep time (TST)
-
Change of sleep diary parameters-TIB
Time frame: 6 weeks
time in bed (TlB)
-
Change of sleep diary parameters-SE
Time frame: 6 weeks
sleep efficiency(SE)
-
Change of sleep diary parameters-NAD
Time frame: 6 weeks
number of awakenings during the night (NAD)
-
Change of sleep diary parameters-WASO
Time frame: 6 weeks
wake time after sleep onset (WASO)
-
Change of lSl
Time frame: 12 weeks
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.
-
Change of PSQl
Time frame: 12 weeks
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.
-
Change of SAS
Time frame: 12 weeks
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.
-
Change of SDS
Time frame: 12 weeks
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.
Sponsors and collaborators
Lead sponsor
Peking University People's Hospital
Other
Registry information
Official study title
A Pilot Study of CBT-I for the Patients With Chronic Insomnia in China
Acronym: CBT-I
Important dates
- Study start
- 2018
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Jul 28, 2026
- Registry last updated
- Jul 28, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.