- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06390254
Resilience-Building Nursing Intervention for Elderly Well-being
Effectiveness of a Resilience-Building Nursing Intervention on Psychological Well-being in Community-Dwelling Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
As the global population ages, there is an increasing need to address the psychological well-being of older adults living independently in the community. Previous research has highlighted the importance of resilience in maintaining mental health and coping with life stressors among older individuals. However, there is limited evidence on the effectiveness of specific interventions aimed at enhancing resilience in this population.
Objective:
The primary objective of this study is to evaluate the effectiveness of a resilience-building nursing intervention in improving the psychological well-being of community-dwelling older adults. Secondary objectives include assessing the impact of the intervention on factors such as social support, coping strategies, and quality of life.
Study Design:
This study will employ a randomized controlled trial design. Participants will be randomly assigned to either the intervention group, receiving the resilience-building nursing intervention, or the control group, receiving standard care.
Intervention:
The resilience-building nursing intervention will consist of individualized sessions delivered by trained nurses. The intervention will focus on enhancing participants' resilience through skill-building exercises, cognitive-behavioral techniques, and psychoeducation. Sessions will be tailored to address the unique needs and challenges of each participant.
Participants:
The target population for this study includes community-dwelling older adults aged 65 and above who are experiencing mild to moderate psychological distress. Participants will be recruited from community centers, senior living facilities, and primary care clinics.
Procedures:
Participants will undergo baseline assessments to collect demographic information and baseline measures of psychological well-being. Those assigned to the intervention group will receive the resilience-building nursing intervention over a specified period, with follow-up assessments conducted at regular intervals to evaluate outcomes.
Outcome Measures:
Primary outcome measures will include changes in psychological well-being, as assessed by standardized scales such as the Geriatric Depression Scale and the Psychological Well-being Scale. Secondary outcome measures will include social support, coping strategies, and quality of life.
Statistical Analysis:
Data will be analyzed using appropriate statistical methods, including t-tests, chi-square tests, and linear regression. Sample size calculations will ensure adequate power to detect meaningful differences between groups.
Ethical Considerations:
This study will adhere to ethical principles outlined in the Declaration of Helsinki. Informed consent will be obtained from all participants, and measures will be taken to ensure participant confidentiality and privacy.
Data Management:
Data will be collected using secure electronic data capture systems and stored in accordance with institutional guidelines and data protection regulations.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mostafa Shaban, Phd
- Phone Number: 00966565644617
- Email: mostafa.shaban2020@cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 60 years and older.
- Individuals living in the community.
- Mild to moderate psychological distress.
Exclusion Criteria:
- Severe cognitive impairment or dementia.
- Significant medical or psychiatric comorbidities that could impede participation in the intervention.
- Inability to understand and communicate in the language used for the intervention materials.
- Concurrent participation in another research study involving psychological interventions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: resilience-building nursing intervention.
Participants receiving the resilience-building nursing intervention.
|
The resilience-building nursing intervention in this study is a multifaceted approach aimed at enhancing the psychological well-being and coping abilities of community-dwelling older adults.
Unlike standard care, which typically focuses on symptom management, this intervention emphasizes proactive strategies to promote resilience and improve overall quality of life.
|
No Intervention: Control
Participants receiving standard care or placebo, depending on the design of your study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychological Well-being Assessment
Time Frame: Psychological well-being will be assessed at baseline, prior to the intervention, and at follow-up assessments conducted at 1 months post-intervention.
|
The main outcome measure of this study is the alteration in psychological well-being among participants, gauged using standardized the Psychological Well-being Scale (PWB)
|
Psychological well-being will be assessed at baseline, prior to the intervention, and at follow-up assessments conducted at 1 months post-intervention.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Zahid N, Martins RS, Zahid W, Khalid W, Azam I, Bhamani SS, Ahmad K, Jabbar A, Shamim MS, Khan RJ, Javed G, Bari E, Asad N, Enam SA. Resilience and its associated factors in brain tumor patients in Karachi, Pakistan: An analytical cross-sectional study. Psychooncology. 2021 Jun;30(6):882-891. doi: 10.1002/pon.5661. Epub 2021 Mar 10.
- Wu Y, Dai Z, Jing S, Liu X, Zhang L, Liu X, Ren T, Fu J, Chen X, Xiao W, Wang H, Huang Y, Wang W, Gu X, Ma L, Zhang S, Yu Y, Li L, Han Z, Su X, Qiao Y. Prevalence and influencing factors of PTSD symptoms among healthcare workers: A multicenter cross-sectional study during the surge period of the COVID-19 pandemic since December 2022 in the Chinese mainland. J Affect Disord. 2024 Mar 1;348:70-77. doi: 10.1016/j.jad.2023.12.008. Epub 2023 Dec 6.
- Jayakrishnan K, Baruah A, Kumar P, Javeth A. Scales and Interventions for Resilience among Treatment-Seeking Patients with Depression: A Systematic Review. J Caring Sci. 2023 May 21;12(2):84-93. doi: 10.34172/jcs.2023.31964. eCollection 2023 Jun.
- Cleary M, Kornhaber R, Thapa DK, West S, Visentin D. The effectiveness of interventions to improve resilience among health professionals: A systematic review. Nurse Educ Today. 2018 Dec;71:247-263. doi: 10.1016/j.nedt.2018.10.002. Epub 2018 Oct 11.
- Chow KM, Tang FWK, Tang WPY, Leung AWY. Resilience-building module for undergraduate nursing students: A mixed-methods evaluation. Nurse Educ Pract. 2020 Nov;49:102912. doi: 10.1016/j.nepr.2020.102912. Epub 2020 Nov 6.
- Henshall C, Davey Z, Srikesavan C, Hart L, Butcher D, Cipriani A. Implementation of a Web-Based Resilience Enhancement Training for Nurses: Pilot Randomized Controlled Trial. J Med Internet Res. 2023 Feb 14;25:e43771. doi: 10.2196/43771.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RBNI-PWB-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Community Dwelling Older Adults
-
Bozyaka Training and Research HospitalCompletedCommunity-dwelling Older Adults
-
Riphah International UniversityCompletedCommunity Dwelling Older AdultsPakistan
-
University of ÉvoraHorizon 2020 - Portugal 2020 (ALT20-03-0145-FEDER-000007 - Project: ESACA); Departamento de Desporto e Saúde, Escola de Ciências e Tecnologia, Universidade de Évora, Évora, Portugal and other collaboratorsCompleted
-
Mélanie LevasseurCanadian Institutes of Health Research (CIHR)Active, not recruitingCommunity-dwelling Older AdultsCanada
-
Maastricht University Medical CenterCompletedCommunity-dwelling Older AdultsNetherlands
-
Cardenal Herrera UniversityCompleted
-
University of FloridaCompletedCommunity-dwelling Older AdultsUnited States
-
Maastricht University Medical CenterCompletedCommunity-dwelling Older AdultsNetherlands
-
National University of SingaporeNational University Hospital, Singapore; Lions Befrienders Service Association...CompletedCommunity-dwelling Older AdultsSingapore
-
University of ÉvoraSão João de Deus School of Nursing; Horizon 2020 - Portugal 2020 (ALT20-03-0145-FEDER-000007...CompletedCommunity-dwelling Older AdultsPortugal
Clinical Trials on Resilience-Enhancing Nursing Suppor
-
Zurich University of Applied SciencesSwiss National Science FoundationCompleted
-
National University of SingaporeNot yet recruitingDepression | Physical Activity | Stress | Anxiety | Resilience | Practice Readiness | Eating Behaviours