NCT06787703

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 16, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

January 16, 2025

Last Update Submit

July 9, 2025

Conditions

Keywords

Older AdultsDisasterPsychologicalFirst AidDignity-Related DistressPsychosocial FrailtyPsychological ResilienceInstitutionalized Elders.

Outcome Measures

Primary Outcomes (1)

  • 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).

    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

    at baseline assessment before the start of the program and at 3 months immediately after the completion of the study

  • Social Frailty Index (SFI)

    at baseline assessment before the start of the program and at 3 months immediately after the completion of the study

Study Arms (2)

Control group

NO INTERVENTION

standard care

Psychological First Aid Intervention

EXPERIMENTAL

Psychological First Aid Intervention

Behavioral: Psychological First Aid Intervention

Interventions

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

Psychological First Aid Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participation in psychological treatments
  • Inability to complete assigned homework
  • Unwillingness to continue studying
  • Logistical challenges such as poor internet connectivity during online sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Almogama and Dar Alsada assisted living facilities

Damanhur, Damanhur, Egypt

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
NO masking
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Faulty of Nursing

Study Record Dates

First Submitted

January 16, 2025

First Posted

January 22, 2025

Study Start

December 3, 2024

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

July 14, 2025

Record last verified: 2025-07

Locations