CBT-I for the Patients With Chronic Insomnia in China

NCT07730593 | Completed

• 1 other identifier: PekingUPH2018
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CBTI Insomnia

Outcome Measures

Primary Outcomes (1)

• Change of Polysomnography (PSG) parameters - TST

  total sleep time

  6 weeks.

Secondary Outcomes (21)

• Change of Polysomnography (PSG) parameters-SOL

  6 weeks

• Change of Polysomnography (PSG) parameters-TIB

  6 weeks

• Change of Polysomnography (PSG) parameters-SE

  6 weeks

• Change of Polysomnography (PSG) parameters-REM latency

  6 weeks

• Change of Polysomnography (PSG) parameters- Stage R

  6 weeks

Study Arms (1)

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.

Behavioral: cognitive behavioral therapy for insomnia

Interventions

cognitive behavioral therapy for insomnia BEHAVIORAL

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

A pilot study of CBT-I for the patients with chronic insomnia in China

Eligibility Criteria

• Age: 37 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• huailian guo, Dr,

  Peking University People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Department of Neurology

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 28, 2026
• Study Start: July 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 28, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)