Activation Programme's Impact on Seniors' Emotionality and Loneliness

March 13, 2025 updated by: Diana Ďuricová

The Impact of an Activation-Socialisation Intervention Programme on the Emotionality and Loneliness of Older Adults in Slovak Elderly Care Facilities - a Pilot Study

The goal of this pilot study is to verify the short-term effectiveness of the Activation-Socialisation Intervention Programme (A-S IP) on the psychosocial survival of older adults in a specific care facility. The main questions it aims to answer are:

  • Does the A-S IP reduce the rate of negative emotional states in older adults?
  • Does the A-S IP increase the rate of positive emotional states in older adults?
  • Does the A-S IP reduce feelings of loneliness in older adults? Researchers will compare the experimental group (older adults participating in the A-S IP) to a control group (older adults not participating in the intervention) to assess the impact on emotional states and loneliness.

Participants will:

  • Participate in 40 activities based on three domains (Laughter Therapy, Reminiscence Therapy, and Cognitive and Social Skills Stimulation)
  • Engage in group activities for four weeks, with daily sessions scheduled in the morning and afternoon
  • Provide feedback on their experiences through surveys and questionnaires to assess their emotional states and satisfaction with the intervention

The study will also explore whether the intervention contributes to the well-being of older adults, as measured by changes in their emotional states and feelings of loneliness.

Study Overview

Detailed Description

The study was registered retrospectively due to limited awareness of the registration requirement for behavioral interventions at the time of study initiation (in 2021). Initially, the research was designed as an exploratory study on a smaller scale, and the registration of a formal trial was not considered necessary.

As an early-career researcher and doctoral student, I was not initially aware of the necessity of registering behavioral intervention studies. However, as the study progressed and its significance became evident, I came to understand the importance of this process. Once I became aware of the registration requirements, I took the necessary steps to complete it accordingly.

Despite the late registration, the study was conducted according to a pre-specified protocol, with all methodological and ethical standards strictly adhered to (approved, for example, by the Ethics Committee of UMB). The hypotheses, study design, and analysis plan were defined prior to data collection, ensuring the integrity and transparency of the research.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hriňová, Slovakia, 96205
        • Hriňovčan care facility for older adults

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • long-term residence in the facility,
  • age over 62,
  • willingness to participate,
  • ability to participate (no severe cognitive or physical impairments)

Exclusion Criteria:

  • significant physical problems,
  • significant mental health problems,
  • unwillingness to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Activation-socialization interventiom programme

The proposed A-S IP (Author, 2021) includes 40 activities of three domains focusing mainly on the social-psychological level of education: the Laughter Therapy Concept (13), the Reminiscence Therapy Concept (13), and the Cognitive and Social Skills Stimulation Intervention Concept (14).

The implementation of the A-S IP activities was designed for a time period of four weeks during weekdays. In the Hriňovčan care facility for older adults, mainly in the common room, two activities were implemented daily during the morning and afternoon hours reserved for this purpose. Morning activities (active) were from 10:00 to 11:00 a.m., and afternoon activities (passive) were from 1:00 to 2:00 p.m. The application of the activities was strictly determined and organised according to a time-thematic schedule that applied rules. The participants participated in group activities, and their participation was voluntary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Scale of Emotional Habitual Subjective Well-being - SEHP (Džuka & Dalbert, 2002)
Time Frame: one month

The Scale of Emotional Habituation of Subjective Well-Being - SEHP (Džuka & Dalbert, 2002) was used to examine the short-term effectiveness of the intervention programme. The self-esteem scale maps the frequency of experiencing positive and negative emotions, totalling 10. Negative emotional experiencing consists of six emotions such as anger, guilt, fear, pain, sadness, and shame, positive emotional experiencing consists of pleasure, physical freshness, joy, and happiness. The participants responded on a six-point scale (6 - almost always; 1 - almost never). The total score of negative emotions is the sum of negative emotions, and the total score of positive emotions is the sum of positive emotions (Džuka et al., 2021). An additional variable, loneliness, was added to the scale. It was assessed on an identical six-point scale.

Unit of Measure: Score (Total score for positive and negative emotions)

one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Lenka Ďuricová, doc., Mgr., PhD., Matej Bel University
  • Principal Investigator: Diana Ďuricová, PhDr., Matej Bel University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2021

Primary Completion (Actual)

March 8, 2021

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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