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Effects of digital cognitive behavioral therapy on insomnia severity index in patients with chronic insomnia

Effects of digital cognitive behavioral therapy on insomnia severity index in patients with chronic insomnia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053172
Enrollment
Unknown
Registered
2021-11-13
Start date
2021-11-10
Completion date
Unknown
Last updated
2022-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic insomnia

Interventions

group 1:Cognitive behavioral therapy for insomnia (CBTi) + routine education
group 2:Regular missions

Sponsors

Shanghai Normal University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Sign the informed consent of the research; 2. Aged over 18 years, able to access the Internet and proficient in the use of smart phones; 3. Self-reported symptoms of insomnia and daytime functional impairment for more than 3 months; 4. Insomnia Severity Index (ISI) questionnaire score greater than or equal to 12.

Exclusion criteria

Exclusion criteria: 1. Self-reported current physical, neurological, or psychiatric disease that affects sleep (eg, congestive heart failure, primary or secondary pain, multiple sclerosis, epilepsy, schizophrenia, or psychotic disorder, major depressive disorder, bipolar disorder, etc.); 2. Epworth Sleepiness Scale score greater than or equal to 10 (suggesting obstructive sleep apnea hypopnea syndrome or lethargy); 3. PHQ-9 scale score greater than or equal to 20 (suggesting that there may be severe depression); 4. GAD-7 scale score greater than or equal to 19 (suggesting that there may be severe anxiety); 5. The current family (such as being pregnant or the child is under 2 years old), life and work (such as night shift work) arrangements will interfere with normal work and rest; 6. Received psychotherapy or drug treatment due to sleep problems, or the treatment has ended within 6 months; 7. The researcher believes that it is not suitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Insomnia severity index;

Secondary

MeasureTime frame
Total sleep time;Self-efficacy-sleep behavior control;Sleep hygiene behavior;Patient Health Questionnaire-9;Generalized Anxiety Disorder Scale;Emotional arousal (point detection task);

Countries

China

Contacts

Public ContactHe Wen

Shanghai Normal University

hewen@shnu.edu.cn+86 13816383911

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026