Tokyo, July 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058408) titled 'Cognitive-Behavioral Therapy Helps Elderly Stroke Patients Recover Mentally and Cognitively' on July 9.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Zhumadian Central Hospital
Condition:
Condition - Acute Cerebral Infarction
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate whether Cognitive-Behavioral Therapy (CBT) can promote posttraumatic growth, cognitive maintenance, and improve functional ability in elderly patients with acute cerebral infarction, and to explore its potential value in post-stroke rehabilitation programs.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Cognitive - Behavioral Therapy combined with conventional treatment: Participants receive 1 - year structured Cognitive - Behavioral Therapy and routine medical care for acute cerebral infarction.
Interventions/Control_2 - Conventional treatment only: Participants receive routine medical care for acute cerebral infarction without Cognitive - Behavioral Therapy, followed for 1 year.
Eligibility:
Age-lower limit - 60
years-old
=
Gender - Male and Female
Key inclusion criteria - Aged 60 years or older.
Diagnosed with acute cerebral infarction (ACI) according to the World Health Organization criteria for ischemic stroke, confirmed by cranial CT.
Time from symptom onset to hospital admission 6 hours or less.
National Institute of Health Stroke Scale (NIHSS) score 20 or less.
Received comprehensive treatment primarily based on interventional therapy.
No history of cognitive impairment, dementia, or mental disorders.
No history of malignant tumors.
History of common chronic diseases allowed if clinically stable.
No experience of other major traumatic events (e.g., bereavement, major surgery) within the past 12 months.
Willing to participate and provided written informed consent.
Key exclusion criteria - Aged younger than 60 years.
Not diagnosed with ACI or diagnosis not confirmed by cranial CT.
Time from symptom onset to hospital admission more than 6 hours.
NIHSS score more than 20.
Did not receive interventional therapy as primary treatment.
History of cognitive impairment, dementia, or mental disorders.
History of malignant tumors.
Unstable common chronic diseases.
Experience of other major traumatic events within the past 12 months.
Unwilling to participate or unable to provide written informed consent.
Target Size - 600
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2019 Year 10 Month 01 Day
Date of IRB - 2019 Year 10 Month 25 Day
Anticipated trial start date - 2020 Year 01 Month 01 Day
Last follow-up date - 2024 Year 07 Month 20 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066774
Disclaimer: Curated by HT Syndication.