Psychological Well-being in Older AdultsNCT06390254
Resilience-Building Nursing Intervention for Elderly Well-being
A study testing Resilience-Enhancing Nursing Suppor in people with Psychological Well-being in Older Adults and Resilience Building Intervention, run by Cairo University.
Trial summary
The objective of this study is to evaluate the impact of a resilience-enhancing nursing intervention on the psychological well-being of older adults living in the community. Participants will benefit from individualized nursing support designed to bolster their resilience and coping skills. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Well-being in Older Adults, Resilience Building Intervention, Community Dwelling Older Adults
- What is being tested?
- Resilience-Enhancing Nursing Suppor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 60 years and older.
- Individuals living in the community.
- Mild to moderate psychological distress.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of a Resilience-Building Nursing Intervention on Psychological Well-being in Community-Dwelling Older Adults
The objective of this study is to evaluate the impact of a resilience-enhancing nursing intervention on the psychological well-being of older adults living in the community. Participants will benefit from individualized nursing support designed to bolster their resilience and coping skills. This intervention will be customized to meet personal requirements and provided in a nurturing setting. Engaging in this study could result in enhanced well-being and life quality. Although some minor discomforts may arise during assessments or interventions, the confidentiality and rights of the participants will be rigorously safeguarded.
Read the 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.
- Conditions
- Psychological Well-being in Older Adults, Resilience Building Intervention, Community Dwelling Older Adults
- Being tested
- Resilience-Enhancing Nursing Suppor
- Keywords
- Resilience, Psychological well-being, Older adults, Nursing intervention, Community-dwelling, Geriatrics, Quality of life
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience-Enhancing Nursing SupporOther
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.
| Study group | Role | What they receive |
|---|---|---|
| resilience-building nursing intervention. | Experimental | Participants receiving the resilience-building nursing intervention. Receives: Other: Resilience-Enhancing Nursing Suppor |
| Control | No intervention | Participants receiving standard care or placebo, depending on the design of your study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Well-being Assessment
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)
Measured: Psychological well-being will be assessed at baseline, prior to the intervention, and at follow-up assessments conducted at 1 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start25 Apr 2024 (estimated)
- Primary completion20 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Psychological Well-being in Older AdultsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The interventional study model for this trial follows a randomized controlled design. Participants will be randomly assigned to either the intervention group or the control group. The intervention group will receive the resilience-building nursing intervention, while the control group will receive standard care. This design allows for a rigorous evaluation of the effectiveness of the intervention by comparing outcomes between the two groups. Blinding of participants and investigators may or may not be feasible depending on the nature of the intervention. The study will adhere to established protocols for randomization, allocation concealment, and blinding to minimize bias and ensure the validity of the findings.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Shaban, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390254
- Sponsor's protocol ID
- RBNI-PWB-001
- Status last verified
- Apr 2024
- First submitted
- 21 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33609048Wu 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.
PubMed 38065482Jayakrishnan 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.
PubMed 37469753Cleary 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.
PubMed 30342300Chow 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.
PubMed 33186821Henshall 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.
PubMed 36787181
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Resilience-Building Nursing Intervention on Psychological Well-being in Community-Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT06390254
- Acronym / sponsor ID
- RBNI-PWB-001
- Conditions
- Psychological Well-being in Older Adults, Resilience Building Intervention, Community Dwelling Older Adults
- Keywords
- Resilience, Psychological well-being, Older adults, Nursing intervention, Community-dwelling, Geriatrics, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Apr 2024 (estimated)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the impact of a resilience-enhancing nursing intervention on the psychological well-being of older adults living in the community. Participants will benefit from individualized nursing support designed to bolster their resilience and coping skills. This intervention will be customized to meet personal requirements and provided in a nurturing setting. Engaging in this study could result in enhanced well-being and life quality. Although some minor discomforts may arise during assessments or interventions, the confidentiality and rights of the participants will be rigorously safeguarded.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The interventional study model for this trial follows a randomized controlled design. Participants will be randomly assigned to either the intervention group or the control group. The intervention group will receive the resilience-building nursing intervention, while the control group will receive standard care. This design allows for a rigorous evaluation of the effectiveness of the intervention by comparing outcomes between the two groups. Blinding of participants and investigators may or may not be feasible depending on the nature of the intervention. The study will adhere to established protocols for randomization, allocation concealment, and blinding to minimize bias and ensure the validity of the findings.
| Arm | Type | Receives |
|---|---|---|
| resilience-building nursing intervention. | Experimental | Other: Resilience-Enhancing Nursing SupporParticipants receiving the resilience-building nursing intervention. |
| Control | No intervention | –Participants receiving standard care or placebo, depending on the design of your study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 60 years and older.
- Individuals living in the community.
- Mild to moderate psychological distress.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resilience-Enhancing Nursing SupporThe 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. | Other | resilience-building nursing intervention. |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Results publication: PubMed 33609048Zahid 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.
- Results publication: PubMed 38065482Wu 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.
- Results publication: PubMed 37469753Jayakrishnan 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.
- Results publication: PubMed 30342300Cleary 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.
- Results publication: PubMed 33186821Chow 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.
- Results publication: PubMed 36787181Henshall 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience-Enhancing Nursing Suppor in people with Psychological Well-being in Older Adults and Resilience Building Intervention, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Shaban, Phd (00966565644617, mostafa.shaban2020@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06390254, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.