Effect of narrative nursing combined with cognitive behavioral rehabilitation on cognitive function and anxiety in patients with Alzheimer's disease
| ISRCTN | ISRCTN10742199 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10742199 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Tianjin Medical University General Hospital |
| Funder | Investigator initiated and funded |
- Submission date
- 21/03/2025
- Registration date
- 27/03/2025
- Last edited
- 26/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Alzheimer's disease (AD) is a progressive neurodegenerative disorder that significantly impacts cognitive function and quality of life. AD patients experience anxiety, which can exacerbate cognitive decline through stress-related mechanisms. This study aims to investigate the effect of narrative nursing combined with cognitive behavioral rehabilitation on cognitive function and anxiety in patients with AD.
Who can participate?
Patients with AD who meet the diagnostic criteria of AD in the 2018 Chinese guidelines for the diagnosis and treatment of dementia and cognitive impairment (II) attending the participating centre.
What does the study involve?
Narrative nursing combined with cognitive behavioral rehabilitation on cognitive function and anxiety in patients with AD. Cognitive behavioral rehabilitation includes: memory training, language communication skills training, computing ability training, and daily life ability training. The implementation of cognitive training is generally recommended to be 5-6 times a week, each time for 1 hour, lasting for 6 months, emphasizing the patient as the main body, and the time and intensity follow the principle of individualization. Cognitive behavioral rehabilitation training is designed and implemented by occupational therapists in hospitals.
What are the possible benefits and risks of participating?
Narrative nursing combined with cognitive behavioral rehabilitation may effectively increase cognitive function, reduce anxiety, and improve the ADL and QOL of patients with AD.
There are no possible risks in this study.
Where is the study run from?
Tianjin Medical University General Hospital, China
When is the study starting and how long is it expected to run for?
January 2020 to December 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dai Li, lidai_2024@126.com
Contact information
Public, Scientific, Principal investigator
Tianjin Medical University General Hospital, No. 154, Anshan Road, Heping District
Tianjin
300052
China
 ORCID ID |
0009-0006-3287-5153 |
|---|---|
| Phone | +8602260363844 |
| lidai_2024@126.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of narrative nursing combined with cognitive behavioral rehabilitation on cognitive function and anxiety in patients with Alzheimer's disease |
| Study objectives | Narrative nursing combined with cognitive behavioral rehabilitation may effectively increase cognitive function, reduce anxiety and improve the ADL and QoL of patients with Alzheimer’s disease |
| Ethics approval(s) |
Approved 25/04/2024, Ethics Committee of Tianjin Medical University General Hospital (No. 154, Anshan Road, Heping District, Tianjin, 300052, China; +86 022-60361044; zyyjgb_ll3@163.com), ref: IRB2024-YX-150-01 |
| Health condition(s) or problem(s) studied | Nursing care for patients with Alzheimer's disease |
| Intervention | Patients with AD were selected using a random sampling method and divided equally into the observation group and the control group using a random number table. Patients in the control group received conventional nursing care. Patients in the observation group received narrative nursing combined with cognitive behavioral rehabilitation in addition to conventional nursing care. Cognitive behavioral rehabilitation includes: memory training, language communication skills training, computing ability training, and daily life ability training. The implementation of cognitive training is generally recommended to be 5-6 times a week, each time for 1 hour, lasting for 6 months, emphasizing the patient as the main body, and the time and intensity follow the principle of individualization. Cognitive behavioral rehabilitation training is designed and implemented by occupational therapists in hospitals. |
| Intervention type | Behavioural |
| Primary outcome measure(s) | The following primary outcome measures are assessed at baseline and 6 months: 1. Cognitive functions measured using Chinese versions of the MMSE and Montreal Cognitive Assessment (MoCA) 2. Anxiety measured using the Generalised Anxiety Disorder-7 (GAD-7) scale 3. Activities of Daily Living (ADLs) and quality of life (QoL) measured using the Alzheimer’s Disease Cooperative Study (ADCS)-ADL and Quality of Life in Alzheimer’s Disease (QoL-AD) scales |
| Key secondary outcome measure(s) | There are no secondary outcome measures |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 172 |
| Total final enrolment | 172 |
| Key inclusion criteria | 1. Meets the diagnostic criteria of AD in the 2018 Chinese guidelines for the diagnosis and treatment of dementia and cognitive impairment (II): Guidelines for the diagnosis and treatment of Alzheimer’s disease 2. Basic language ability for simple communication 3. Meets the requirements of medical ethics in our hospital, and their family members signed the informed consent form |
| Key exclusion criteria | 1. Severe psychiatric disorders that would prevent participation in cognitive behavioral therapy 2. Acute or unstable cardiovascular conditions requiring intensive medical management 3. Severe cognitive impairment (Mini-Mental State Examination [MMSE] score ≤10) that would preclude meaningful participation in the intervention |
| Date of first enrolment | 10/01/2020 |
| Date of final enrolment | 08/11/2020 |
Locations
Countries of recruitment
- China
Study participating centre
300052
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dai Li, lidai_2024@126.com. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/03/2025: Study's existence confirmed by the Ethics Committee of Tianjin Medical University General Hospital. The previous ethics approval has expired, and the new ethics approval date, effective from 25/04/2024, represents the approval now in effect.
