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Effect of Esketamine on Cognitive Behavioral Therapy for Insomnia Adherence in Patients with Comorbid Insomnia and Depression

Effect of Esketamine on Cognitive Behavioral Therapy for Insomnia Adherence in Patients with Comorbid Insomnia and Depression

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112142
Enrollment
Unknown
Registered
2025-11-11
Start date
2025-11-30
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Insomnia, Depression

Interventions

Exposure group:None
Control group:None

Sponsors

Shanghai Fourth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. Received treatment for sleep problems at the Department of Sleep Medicine, Shanghai Fourth People's Hospital between February 2022 and February 2025. 3. Diagnosed with insomnia disorder according to ICSD-3 criteria. 4. Diagnosed with major depressive disorder according to DSM-5 criteria. 5. Insomnia Severity Index (ISI) score >7 and Hospital Anxiety and Depression Scale-Depression (HADS-D) subscore >10. 6. Underwent treatment with either combined esketamine and CBT-I or CBT-I alone. 7. Availability of complete baseline data of interest.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of schizophrenia, bipolar disorder, recurrent panic attacks, or active suicidality. 2. Presence of dysarthria, hearing impairment, or cognitive dysfunction. 3. Other types of sleep disorders, such as sleep apnea, restless legs syndrome, or sleep-related movement disorders. 4. Receipt of other interventional treatments.

Design outcomes

Primary

MeasureTime frame
Adherence to Behavioral Strategies;

Secondary

MeasureTime frame
Bedtime variability;Wake-up time variability;CBT-I Completion Rate;Insomnia Severity Index;Response rate and remission rate;Hospital Anxiety and Depression Scale;Equivalent dose of benzodiazepines;

Countries

China

Contacts

Public ContactQifang Li

Shanghai Fourth People's Hospital

liqifang2004@126.com+86 136 7183 4019

Outcome results

None listed

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