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Efficacy of brief behavioral therapy for insomnia after coronavirus disease 2019 (COVID-19) infection

Efficacy of brief behavioral therapy for insomnia after coronavirus disease 2019 (COVID-19) infection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077969
Enrollment
Unknown
Registered
2023-11-24
Start date
2023-08-01
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Chronic insomnia

Interventions

Experimental Group:Brief behavioral therapy for insomnia

Sponsors

The First Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 16-80 years, gender is not limited; 2. Insomnia symptoms after COVID-19 infection; 3. Meeting the Diagnostic and Statistical Manual of Mental Disorders V Edition (DSM-V) criteria for insomnia: (1) Patients complained of dissatisfaction with sleep quality or sleep duration, including inability to fall asleep, waking up early, and difficulty maintaining stable sleep (frequent awakenings at night and difficulty falling asleep after waking up); (2) Insomnia disorder leads to significant clinical symptoms or impaired social, occupational, educational, and behavioral functions; (3) The frequency of the above symptoms was more than 3 times/week; (4) The above symptoms have lasted for at least 3 months; (5) Adequate sleep opportunities and good sleep environment; (6) Complain of at least one negative daytime effect (e.g., fatigue, impaired functioning, or mood disturbance) attributable to poor sleep; (7) The above symptoms cannot be explained by other sleep-wake disorders (e.g., narcolepsy, respiratory-related sleep disorders, circadian rhythm sleep disorders, parasomnia); (8) The above symptoms are not physical effects caused by drugs or substances (e.g., drug abuse); (9) Insomnia symptoms are not secondary to a physical or psychiatric illness; 4. Able to read and understand Chinese and use electronic devices; 5. No obvious psychological stress events, no recent serious life and psychological events that interfere with sleep (except for fear of sleep); 6. Agree to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Currently suffering from bipolar disorder, schizophrenia, post-traumatic stress disorder and other mental disorders that affect sleep; 2. Suffering from severe intellectual disability or physical illness; 3. Pregnant or lactating women; 4. History of epilepsy or brain injury; 5. Received cognitive-behavioral therapy for insomnia; 6. Other situations not suitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Insomnia Severity Index, ISI;The reduction in the usage of sedative-hypnotic medications;

Secondary

MeasureTime frame
Night time sleep status;Self-Rating Depression Scale, SDS;Pittsburgh Sleep Quality Index, PSQI;Fatigue Scale-14, FS-14;The Epworth Sleeping Scale, ESS;Coronavirus Impact Scale, CIS;Self-Rating Anxiety Scale, SAS;

Countries

China

Contacts

Public ContactYi Chang

The First Affiliated Hospital of Dalian Medical University

changee99@gmail.com+86 139 4094 3457

Outcome results

None listed

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