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A randomised parallel controlled study of digital brief behavioral therapy for insomnia in the treatment of insomnia disorder

The Study of Diagnosis, Treatment Efficacy, and Prognostic Biomarkers in Insomnia Disorder based on Brain Spatiotemporal Patterns

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093745
Enrollment
Unknown
Registered
2024-12-11
Start date
2024-12-12
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

Insomnia disorder

Interventions

Treatment Group for ID:digital brief behavioral therapy for insomnia, dBBTI
Control Group for ID:Health education on sleep hygiene

Sponsors

Peking University Sixth Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for patients with ID: age 18-60 years, right-handed. (1) Those who met the diagnostic criteria for insomnia disorder (DSM-5, 307.42 (F51.01)); (2) Those who had no history of medication, or those who had a history of previous medication or were currently on medication but still met the above criteria. For those who used medication, information such as the type and dose of medication and duration was recorded in detail as a backup. Inclusion criteria for healthy control: age 18-60 years, right-handed, no smoking, no alcoholism, no history of neuropsychiatric disorders, keeping regular sleep habits.

Exclusion criteria

Exclusion criteria: (1) History of psychiatric or neurological disorders; (2) History of severe cardiac, hepatic, renal, infectious, and other physical illnesses; (3) AHI = 5; (4) PLMIS = 20 ; (5) Shift work or having experienced travelling across the meridian in the past 3 months; (6) Women who are pregnant or breastfeeding; (7) Contraindications to MRI scanning; (8) BMI = 35 kg/m2; (9) Previous cognitive behavioural therapy for insomnia.

Design outcomes

Primary

MeasureTime frame
Insomnia Severity Index;

Secondary

MeasureTime frame
Self-Rating Anxiety Scale Score;Self-rating Depression Scale Score;Pittsburgh sleep quality index score;Fatigue Severity Scale Score;Pre-sleep Arousal Scale Score;Dysfunctional Beliefs and Attitudes about Sleep Scale Score;EEG-fMRI;

Countries

China

Contacts

Public ContactHongqiang, Sun

Peking University Sixth Hospital

sunhq@bjmu.edu.cn+86 139 1104 3951

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026