Skip to content

The effect of Cognitive Behavioral Therapy on post stroke insomnia prevention: a randomized controlled trial.

The effect of Cognitive Behavioral Therapy on post stroke insomnia prevention

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035316
Enrollment
Unknown
Registered
2020-08-08
Start date
2020-09-15
Completion date
Unknown
Last updated
2020-08-10

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

Conditions

Stroke related insomnia

Interventions

experimental group:Cognitive Behavioral Therapy for insonmia

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients between 18 to 80 years old; 2. First onset of acute ischemic stroke (with symptoms of neurological impairment); 3. Informed consent has been signed.

Exclusion criteria

Exclusion criteria: 1. CT or MR diagnosis of cerebral hemorrhage or other brain diseases, such as intracranial tumors, abscesses, metabolic encephalopathy, etc. 2. There were only separate visual changes, sensory symptoms (such as numbness), dizziness or vertigo, and no evidence of acute ischemic stroke on brain imaging (CT or MRI). 3. mRS score more than 2. 4. The acute ischemic stroke was so severe that the patient needed to stay in bed for a long time or NIHSS >14. 5. The patient still needs continuous ECG monitoring 7 days after the onset of acute ischemic stroke. 6. Any type of surgery is planned or may be performed in the next three months. 7. Patients who have a prior diagnosis of anxiety or depression disorder, requiring long-term use of anti-anxiety/depression medications. 8. Patients with pre-existing refractory insomnia need to take long-term medication to assist sleep. 9. Women of childbearing age who are pregnant or have planned pregnancy, and women who are breastfeeding. 10. Patients with malignant tumor or other serious non-cardiovascular and cerebrovascular diseases, and the expected life time less than 3 months. 11. Participated in other clinical drug or device studies within 30 days. 12. Inability to understand and/or comply with CBTI intervention and/or follow-up due to severe cognitive impairment, mental disorders.

Design outcomes

Primary

MeasureTime frame
Stroke related insomnia in acute ischemic patients within 7 days of first onset;

Secondary

MeasureTime frame
Stroke related insomnia;sleep quality;Anxiety disorder;Depressive disorder;Neurological impairment;Quality of life;Recurrence rate of stroke;

Countries

China

Contacts

Public ContactShiyu Hu

Shenzhen Second People's Hospital

15007553360@163.com+86 15007553360

Outcome results

None listed

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