ElderlyNCT06787703
Are Older Adults Prepared to Respond to Disasters? Psychological First Aid on Dignity-Related Distress, Social Frailty, and Psychological Resilience
A study testing Psychological First Aid Intervention in people with Elderly and Psychological Adaptation, run by Cairo University at 1 site in Egypt.
Trial summary
The rapid increase in the global aging population has drawn attention to the unique challenges faced by institutionalized elders. These individuals often contend with various forms of psychosocial stress, including dignity-related distress, social frailty, and reduced psychological resilience. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly, Psychological Adaptation, First Aid
- What is being tested?
- Psychological First Aid Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Dec 2024to 30 Mar 2025
- 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
- Aged 60 years or older.
- Recently retired, within a maximum of one month from job cessation.
- Capable of meaningful and clear communication.
- Provide signed informed consent to participate.
Who cannot join
- Participation in psychological treatments
- Inability to complete assigned homework
- Unwillingness to continue studying
- Logistical challenges such as poor internet connectivity during online sessions.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Almogama and Dar Alsada assisted living facilities
Damanhur, Damanhur
About this study
Official title: Are Older Adults Prepared to Respond to Disasters? A Randomized Controlled Study Evaluating the Effectiveness of Psychological First Aid on Dignity-Related Distress, Social Frailty, and Psychological Resilience Among Institutionalized Elders
The rapid increase in the global aging population has drawn attention to the unique challenges faced by institutionalized elders. These individuals often contend with various forms of psychosocial stress, including dignity-related distress, social frailty, and reduced psychological resilience. Dignity-related distress, characterized by feelings of worthlessness or loss of respect, significantly impacts mental health and quality of life among older adults, especially those in long-term care facilities. Similarly, social frailty-marked by diminished social networks and weakened interpersonal interactions-further exacerbates their vulnerability to loneliness and mental health disorders. Enhancing psychological resilience, or the capacity to adapt to adversity, is therefore critical to improving their overall well-being.
Psychological First Aid (PFA) is a structured intervention designed to provide immediate support and foster adaptive coping strategies during crises. While PFA has been widely implemented in disaster and emergency contexts, its application in addressing the psychosocial needs of institutionalized elders remains underexplored. Given its focus on promoting safety, comfort, and connectedness, PFA may hold potential for mitigating dignity-related distress, strengthening social bonds, and enhancing psychological resilience among this vulnerable population.
This study seeks to evaluate the effectiveness of PFA in alleviating dignity-related distress, reducing social frailty, and bolstering psychological resilience among institutionalized elders. By addressing these intertwined psychosocial factors, the research aims to contribute to the growing body of evidence on interventions tailored to the unique needs of older adults in care settings
Read the detailed description
The study addresses critical aspects of elderly care, particularly for those in institutional settings. Institutionalized elders often face challenges such as diminished dignity, social isolation, and reduced resilience, which can significantly impact their mental and emotional well-being. By evaluating the role of Psychological First Aid (PFA), a practical and empathetic intervention designed to provide immediate emotional support, the study explores its potential to alleviate dignity-related distress, mitigate social frailty, and enhance psychological resilience. The findings have important implications for improving the quality of life for institutionalized elders by promoting a sense of self-worth, strengthening social connections, and fostering adaptability to life's challenges, ultimately contributing to a more holistic approach to elder care.As well, this study involved an innovative application of the psychological first aid interventions. While PFA has been widely used in disaster response and emergency settings, its application in addressing the day-to-day struggles of institutionalized elders is novel. The study expands the scope of PFA, demonstrating its adaptability and potential for broader usage in healthcare and social care settings. The findings of this study could influence policies and practices in eldercare by advocating for the integration of PFA into standard care protocols. It highlights the need for training caregivers in PFA to improve the holistic care of institutionalized elders. In general, the study adds to the growing body of gerontological research, offering evidence-based strategies to address the complex psychological and social needs of the aging population in institutional settings.
- Conditions
- Elderly, Psychological Adaptation, First Aid, Stress, Psychological Stress
- Being tested
- Psychological First Aid Intervention
- Keywords
- Older Adults, Disaster, Psychological, First Aid, Dignity-Related Distress, Psychosocial Frailty, Psychological Resilience, Institutionalized Elders.
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological First Aid InterventionBehavioural
Psychological first aid is a compassionate and supportive presence designed to mitigate acute distress and asses the need for continued mental health care. The intervention aims to enhance the compassionate presence, assist with needs and promote adaptive functioning. The intervention encompasses seven main themes (RAPID model, emotion stabilization, self-compassion, reframing, instillation of hope and empowerment) that will be covered through a series of five training exercises conducted on 6 sessions. Each session ranged in duration from 30 to 45 minutes.
The program going along the RAPID PFA model, that represents a simple structure of (R for: establishing rapport and reflective listening, A: assessment, P: prioritization, I: intervention and D: disposition).
The program going along the RAPID PFA model, that represents a simple structure of (R for: establishing rapport and reflective listening, A: assessment, P: prioritization, I: intervention and D: disposition). The
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | standard care |
| Psychological First Aid Intervention | Experimental | Psychological First Aid Intervention Receives: Behavioral: Psychological First Aid Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Resilience Evaluation Scale
The Resilience Evaluation Scale (RES) consists of 9 items rated on a 5-point Likert scale ranging from 0 (completely disagree) to 4 (completely agree). Participants assess the extent to which they agree with statements about how they "typically respond to challenging situations." the scale's original authors identified a two-factor structure: self-efficacy, which includes items 2, 3, 4, 5, 6, and 8 (subscale range: 0-24), and self-confidence, comprising items 1, 7, and 9 (subscale range: 0-12).
Measured: at baseline assessment before the start of the program and at 3 months immediately after the completion of the study
Secondary outcomes (2)
Patient Dignity Inventory
The Patient Dignity Inventory (PDI) is a 25-item survey designed to assess dignity-related distress in individuals, particularly those in palliative care. Each item is scored on a 5-point Likert scale, with responses ranging from 1 ("not a problem") to 5 ("an overwhelming problem"). The PDI encompasses five domains of distress: symptom distress, existential distress, dependency, peace of mind, and social support.
Measured: at baseline assessment before the start of the program and at 3 months immediately after the completion of the study
Social Frailty Index (SFI)
The Social Frailty Index (SFI) was developed by Shah et al., 2023, is a multidimensional tool used to evaluate the social aspects of frailty, particularly among older adults. It focuses on identifying individuals at risk of social vulnerabilities that can impact their overall health and well-being. The Social Frailty Index includes age, gender, and eight social characteristics and accurately risk-stratifies older adults.
Measured: at baseline assessment before the start of the program and at 3 months immediately after the completion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start3 Dec 2024
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- Psychological first aid is a compassionate and supportive presence designed to mitigate acute distress and asses the need for continued mental health care. The intervention aims to enhance the compassionate presence, assist with needs and promote adaptive functioning. The intervention encompasses seven main themes (RAPID model, emotion stabilization, self-compassion, reframing, instillation of hope and empowerment) that will be covered through a series of five training exercises conducted on 6 sessions. Each session ranged in duration from 30 to 45 minutes.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Damanhour University, Prince Sattam Bin Abdulaziz University, Alexandria University
- Responsible party
- Principal investigator, Mahmoud Ahmed Ahmed Ahmed Elsheikh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787703
- Sponsor's protocol ID
- 106-C
- Status last verified
- Jul 2025
- First submitted
- 16 Jan 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: after completion of study, the results will be published at data repository platform.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Older Adults Prepared to Respond to Disasters? A Randomized Controlled Study Evaluating the Effectiveness of Psychological First Aid on Dignity-Related Distress, Social Frailty, and Psychological Resilience Among Institutionalized Elders
- ClinicalTrials.gov ID
- NCT06787703
- Acronym / sponsor ID
- 106-C
- Conditions
- Elderly, Psychological Adaptation, First Aid, Stress, Psychological Stress
- Keywords
- Older Adults, Disaster, Psychological, First Aid, Dignity-Related Distress, Psychosocial Frailty, Psychological Resilience, Institutionalized Elders.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Damanhour University, Prince Sattam Bin Abdulaziz University, Alexandria University
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 22 Jan 2025 (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 rapid increase in the global aging population has drawn attention to the unique challenges faced by institutionalized elders. These individuals often contend with various forms of psychosocial stress, including dignity-related distress, social frailty, and reduced psychological resilience. Dignity-related distress, characterized by feelings of worthlessness or loss of respect, significantly impacts mental health and quality of life among older adults, especially those in long-term care facilities. Similarly, social frailty-marked by diminished social networks and weakened interpersonal interactions-further exacerbates their vulnerability to loneliness and mental health disorders. Enhancing psychological resilience, or the capacity to adapt to adversity, is therefore critical to improving their overall well-being.
Psychological First Aid (PFA) is a structured intervention designed to provide immediate support and foster adaptive coping strategies during crises. While PFA has been widely implemented in disaster and emergency contexts, its application in addressing the psychosocial needs of institutionalized elders remains underexplored. Given its focus on promoting safety, comfort, and connectedness, PFA may hold potential for mitigating dignity-related distress, strengthening social bonds, and enhancing psychological resilience among this vulnerable population.
This study seeks to evaluate the effectiveness of PFA in alleviating dignity-related distress, reducing social frailty, and bolstering psychological resilience among institutionalized elders. By addressing these intertwined psychosocial factors, the research aims to contribute to the growing body of evidence on interventions tailored to the unique needs of older adults in care settings
Detailed description
The study addresses critical aspects of elderly care, particularly for those in institutional settings. Institutionalized elders often face challenges such as diminished dignity, social isolation, and reduced resilience, which can significantly impact their mental and emotional well-being. By evaluating the role of Psychological First Aid (PFA), a practical and empathetic intervention designed to provide immediate emotional support, the study explores its potential to alleviate dignity-related distress, mitigate social frailty, and enhance psychological resilience. The findings have important implications for improving the quality of life for institutionalized elders by promoting a sense of self-worth, strengthening social connections, and fostering adaptability to life's challenges, ultimately contributing to a more holistic approach to elder care.As well, this study involved an innovative application of the psychological first aid interventions. While PFA has been widely used in disaster response and emergency settings, its application in addressing the day-to-day struggles of institutionalized elders is novel. The study expands the scope of PFA, demonstrating its adaptability and potential for broader usage in healthcare and social care settings. The findings of this study could influence policies and practices in eldercare by advocating for the integration of PFA into standard care protocols. It highlights the need for training caregivers in PFA to improve the holistic care of institutionalized elders. In general, the study adds to the growing body of gerontological research, offering evidence-based strategies to address the complex psychological and social needs of the aging population in institutional settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Psychological first aid is a compassionate and supportive presence designed to mitigate acute distress and asses the need for continued mental health care. The intervention aims to enhance the compassionate presence, assist with needs and promote adaptive functioning. The intervention encompasses seven main themes (RAPID model, emotion stabilization, self-compassion, reframing, instillation of hope and empowerment) that will be covered through a series of five training exercises conducted on 6 sessions. Each session ranged in duration from 30 to 45 minutes.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –standard care |
| Psychological First Aid Intervention | Experimental | Behavioral: Psychological First Aid InterventionPsychological First Aid Intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 60 years or older.
- Recently retired, within a maximum of one month from job cessation.
- Capable of meaningful and clear communication.
- Provide signed informed consent to participate.
Key exclusion criteria (4 listed)
- Participation in psychological treatments
- Inability to complete assigned homework
- Unwillingness to continue studying
- Logistical challenges such as poor internet connectivity during online sessions.
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 |
|---|---|---|
| Psychological First Aid InterventionPsychological first aid is a compassionate and supportive presence designed to mitigate acute distress and asses the need for continued mental health care. The intervention aims to enhance the compassionate presence, assist with needs and promote adaptive functioning. The intervention encompasses seven main themes (RAPID model, emotion stabilization, self-compassion, reframing, instillation of hope and empowerment) that will be covered through a series of five training exercises conducted on 6 sessions. Each session ranged in duration from 30 to 45 minutes. The program going along the RAPID PFA model, that represents a simple structure of (R for: establishing rapport and reflective listening, A: assessment, P: prioritization, I: intervention and D: disposition). The program going along the RAPID PFA model, that represents a simple structure of (R for: establishing rapport and reflective listening, A: assessment, P: prioritization, I: intervention and D: disposition). The | Behavioural | Psychological First Aid Intervention |
Primary outcome
Psychological Resilience Evaluation Scale
Time frame: at baseline assessment before the start of the program and at 3 months immediately after the completion of the study
The Resilience Evaluation Scale (RES) consists of 9 items rated on a 5-point Likert scale ranging from 0 (completely disagree) to 4 (completely agree). Participants assess the extent to which they agree with statements about how they "typically respond to challenging situations." the scale's original authors identified a two-factor structure: self-efficacy, which includes items 2, 3, 4, 5, 6, and 8 (subscale range: 0-24), and self-confidence, comprising items 1, 7, and 9 (subscale range: 0-12).
2 secondary outcomes
Patient Dignity Inventory
Time frame: at baseline assessment before the start of the program and at 3 months immediately after the completion of the study
Social Frailty Index (SFI)
Time frame: at baseline assessment before the start of the program and at 3 months immediately after the completion of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: Undecided. after completion of study, the results will be published at data repository platform.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological First Aid Intervention in people with Elderly and Psychological Adaptation, run by Cairo University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Resilience Evaluation Scale (time frame: at baseline assessment before the start of the program and at 3 months immediately after the completion of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2025.