- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06787703
Are Older Adults Prepared to Respond to Disasters? Psychological First Aid on Dignity-Related Distress, Social Frailty, and Psychological Resilience
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Damanhur, Egypt
- Almogama and Dar Alsada assisted living facilities
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Participation in psychological treatments
- Inability to complete assigned homework
- Unwillingness to continue studying
- Logistical challenges such as poor internet connectivity during online sessions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
standard care
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|
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Experimental: Psychological First Aid Intervention
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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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
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at baseline assessment before the start of the program and at 3 months immediately after the completion of the study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
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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
|
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.
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at baseline assessment before the start of the program and at 3 months immediately after the completion of the study
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 106-C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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