UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058408 |
|---|---|
| Receipt number | R000066774 |
| Scientific Title | Cognitive-Behavioral Therapy Promotes Posttraumatic Growth and Cognitive Maintenance in Elderly Patients with Acute Cerebral Infarction: A Randomized Clinical Trial |
| Date of disclosure of the study information | 2025/07/09 |
| Last modified on | 2025/07/09 14:31:05 |
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Basic information
Public title
Cognitive-Behavioral Therapy Helps Elderly Stroke Patients Recover Mentally and Cognitively
Acronym
CBT-PTG-CM-ACI
Scientific Title
Cognitive-Behavioral Therapy Promotes Posttraumatic Growth and Cognitive Maintenance in Elderly Patients with Acute Cerebral Infarction: A Randomized Clinical Trial
Scientific Title:Acronym
CBT Promotes PTG and CM in Elderly ACI Patients: A Randomized Clinical Trial
Region
| Asia(except Japan) |
Condition
Condition
Acute Cerebral Infarction
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Posttraumatic growth (PTG) assessed by the Posttraumatic Growth Inventory (PTGI) at 1-year follow-up.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 100 | 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 sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Guangzhou |
| Middle name | |
| Last name | Yu |
Organization
Zhumadian Central Hospital
Division name
Department of Neurology III
Zip code
463000
Address
No. 747, Zhonghua Road, Zhumadian City, Henan Province, China
TEL
0086-0396-2726128
guangzhouyu_medical@outlook.com
Public contact
Name of contact person
| 1st name | Guangzhou |
| Middle name | |
| Last name | Yu |
Organization
Zhumadian Central Hospital
Division name
Department of Neurology III
Zip code
463000
Address
No. 747, Zhonghua Road, Zhumadian City, Henan Province, China
TEL
0086-0396-2726128
Homepage URL
guangzhouyu_medical@outlook.com
Sponsor or person
Institute
Zhumadian Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Zhumadian Central Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee of Zhumadian Central Hospital
Address
No. 747, Zhonghua Road, Zhumadian City, Henan Province, China
Tel
0086-0396-2726217
zmdszxyy@163.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
600
Results
After 1 year, the intervention group showed significantly higher posttraumatic growth, cognitive function and functional ability scores than baseline and the non-intervention group. The non-intervention group saw no improved posttraumatic growth and decreased cognitive and functional ability. Thus, cognitive-behavioral therapy independently promotes these in elderly acute cerebral infarction patients.
Results date posted
| 2025 | Year | 07 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 09 | Day |
Last modified on
| 2025 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066774
