Activation-Socialization Intervention Program for Seniors

April 4, 2026 updated by: Diana Ďuricová

Verification of the Impact of an Activation-Socialization Intervention Program in the Banská Bystrica Self-Governing Region of the Slovak Republic

Objective No. 1: Verify the short-term effectiveness of the Activation-Socialization Intervention Program on the experiences (emotionality, anxiety) and behavior (agitated behavior) of seniors in the experimental and control groups.

Objective No. 2: Verify the long-term effectiveness of the Activation-Socialization Intervention Program on the experience (emotionality, anxiety) and behavior (agitated behavior) of seniors in the experimental and control groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The main question the project seeks to answer is:

Are there significant differences in the degree of emotional experience- negative and positive emotional states-anxiety, and the occurrence of agitated behavior-aggressive, physically non-aggressive, and verbally agitated behavior-between the experimental group of older adults and the control group of older adults during the measurements (pretest measurement vs. retest measurement; pretest measurement vs. retest measurement II; retest measurement vs. retest measurement II)?

Researchers will compare the experimental group (older adults participating in the A-S IP program) with the control group (older adults not participating in the intervention) to assess the impact on emotional states, anxiety, and agitated behavior.

Participants will:

  • Participate in 45 activities based on three areas (Laughter therapy, Reminiscence therapy, and Intervention to stimulate of cognitive and social skills)
  • Engage in group activities for 5 weeks, with daily sessions scheduled for the morning and afternoon
  • Provide feedback on their experiences through surveys and questionnaires to assess their emotional states, anxiety and agitated behavior, and satisfaction with the intervention

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Slovakia
      • Banská Bystrica, Slovakia, 974 11
        • Office of the Higher Territorial Unit of Banská Bystrica

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for edlerly adults:

  • age over 62 years,
  • residence in a facility for seniors in in the Banská Bystrica Self-Governing Region of the Slovak Republic,
  • willingness and ability to participate in the research (taking into account physiological and psychological health limitations),
  • availability of an internal or external psychologist/psychiatris
  • the presence of at least two employees with the required education (social work, andragogy, psychology, nursing) or completed training (social rehabilitation instructor) who have participated in the Education Program

Exclusion Criteria for elderly adults:

  • age 62 years and under, residence in another type of facility (e.g. specialized facility, crisis center, community center), residence outside the territory of the Banská Bystrica Self-Governing Region of the Slovak Republic,
  • inability to participate in the research due to serious health problems,
  • unavailability of professional staff or psychologist/psychiatrist,
  • unwillingness or disagreement with participation in the research
  • participation in another intervention program during the duration of the research
  • non-participation of employees in the Education Program

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Activation-socialization Interventiom Programme
The experimental group participates in an Activation-Socialization Intervention Program for five weeks.
Other: Activation and Socialization Intervention Program
The content of the Activation and Socialization Intervention Program is designed based on the identified needs and interests of seniors. It consists of 45 activities, which are divided into three concepts. Laughter therapy (Ďuricová, 2026c) includes 13 activities, Reminiscence therapy (Ďuricová, 2026b) includes 13 activities, The intervention to stimulate cognitive abilities and social skills (Ďuricová, 2026a) consists of 19 activities. The implementation of the Program is planned for a period of five weeks, during which activities take place regularly every working day in two blocks. Each day includes two activities - one in the morning (10:00-11:00 a.m.) and one in the afternoon (1:00-2:00 p.m.). The proposed activities are incorporated into the program in a targeted manner and planned in advance according to methodological principles, with their schedule respecting the principles, which are listed in publications (Ďuricová, 2026a, 2026b, 2026c).
No Intervention: Control group
The control group does not participate in the intervention program.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Scale of Emotional Habituation of Subjective Well-Being - SEHP (Džuka & Dalbert, 2002)
Time Frame: two months
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).
two months
The Anxiety and Trait Anxiety Inventory - STAI (Spielberger et al., 1970, ed. Ruisel et al., 1980)
Time Frame: two months
The Anxiety and Trait Anxiety Inventory - STAI (Spielberger et al., 1970, ed. Ruisel et al., 1980), specifically only the anxiety portion of the questionnaire, i.e., the Scale for the Measurement of Anxiety as a Condition, STAI X-1. This is the self-assessment portion of the questionnaire, which maps the degree of current experience of feelings of tension, tenseness, nervousness, fear, and apprehension. It contains 20 statements, some of which relate to the existence of these feelings and some of which relate to their absence. Seniors rated their experiencing on a four-point scale (4 - very, 1 - not at all). The result is a total score, which is obtained by summing the values on the scale taking into account reverse scaling. The range of the total score is 20-80. We based the norms on those presented in the manual by Ruisel et al. (1980).
two months
Cohen-Mansfield Agitation Inventory - CMAI (Cohen-Mansfield, 1991), specifically CMAI-D, long version.
Time Frame: two months
Cohen-Mansfield Agitation Inventory - CMAI (Cohen-Mansfield, 1991), specifically CMAI-D, long version. It is an assessment questionnaire, designed for institutional staff, that reflects the manifestations and frequency of agitated behaviors among older persons living in the facility. It includes 29 manifestations of behaviour, and social workers rated the behaviour of the elderly during the last 2 weeks on a seven-point scale (7 - several times per hour, 1 - never). The total score is calculated by summing all items (Sánchez, 2016). It reaches values of 29-203, based on the information that a total score (greater than) > 45 indicates significant agitation (Cohen-Mansfield & al., 1989). Cohen-Mansfield (1991) used factor analysis to develop three factors of agitated behaviour that occur in a nursing home: factor 1 - aggressive behavior; factor 2 - physically non-aggressive behavior; factor 3 - verbally agitated behavior.
two months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reflection Questionnaire (Ďuricová, 2023)
Time Frame: six weeks
This is a questionnaire that maps client satisfaction with activities. It includes three statements, with clients expressing their level of agreement on a three-point scale (agree - have no strong opinion - disagree) in the areas of: re participation, usefulness and disinterest in the activities. It also includes three incomplete sentences that seniors complete at will. Responses reflect what clients learned/how the activities helped them, what they liked most about the activities, what they would remove from the activities.
six weeks
The Scale of Emotional Habituation of Subjective Well-Being - SEHP (Džuka & Dalbert, 2002)
Time Frame: six months
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).
six months
The Anxiety and Trait Anxiety Inventory - STAI (Spielberger et al., 1970, ed. Ruisel et al., 1980)
Time Frame: six months
The Anxiety and Trait Anxiety Inventory - STAI (Spielberger et al., 1970, ed. Ruisel et al., 1980), specifically only the anxiety portion of the questionnaire, i.e., the Scale for the Measurement of Anxiety as a Condition, STAI X-1. This is the self-assessment portion of the questionnaire, which maps the degree of current experience of feelings of tension, tenseness, nervousness, fear, and apprehension. It contains 20 statements, some of which relate to the existence of these feelings and some of which relate to their absence. Seniors rated their experiencing on a four-point scale (4 - very, 1 - not at all). The result is a total score, which is obtained by summing the values on the scale taking into account reverse scaling. The range of the total score is 20-80. We based the norms on those presented in the manual by Ruisel et al. (1980).
six months
Cohen-Mansfield Agitation Inventory - CMAI (Cohen-Mansfield, 1991), specifically CMAI-D, long version.
Time Frame: six months
Cohen-Mansfield Agitation Inventory - CMAI (Cohen-Mansfield, 1991), specifically CMAI-D, long version. It is an assessment questionnaire, designed for institutional staff, that reflects the manifestations and frequency of agitated behaviors among older persons living in the facility. It includes 29 manifestations of behaviour, and social workers rated the behaviour of the elderly during the last 2 weeks on a seven-point scale (7 - several times per hour, 1 - never). The total score is calculated by summing all items (Sánchez, 2016). It reaches values of 29-203, based on the information that a total score (greater than) > 45 indicates significant agitation (Cohen-Mansfield & al., 1989). Cohen-Mansfield (1991) used factor analysis to develop three factors of agitated behaviour that occur in a nursing home: factor 1 - aggressive behavior; factor 2 - physically non-aggressive behavior; factor 3 - verbally agitated behavior.
six months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Diana Ďuricová

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
European Union

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Lenka Ďuricová, doc., Mgr., PhD., 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.

General Publications

  • Spielberger, Ch. D., Gorsuch, R. L., & Lushene, R. E. (1970). Stai manual for the state trait anxiety inventory. Consulting Psychologists Press.
  • Ďuricová, D. (2026c). Aktivizačno-socializačný intervenčný program pre seniorov: Terapia smiechom [Activation-Socialization Intervention Program for Seniors: Laughter Therapy]. Grada.
  • Ďuricová, D. (2026b). Aktivizačno-socializačný intervenčný program pre seniorov: Reminiscenčná terapia [Activation-Socialization Intervention Program for Seniors: Reminiscence Therapy]. Grada.
  • Ďuricová, D. (2026a). Aktivizačno-socializačný intervenčný program pre seniorov: Intervencia na stimuláciu kognitívnych schopností a sociálnych zručností [Activation-Socialization Intervention Program for Seniors: Intervention to Stimulate Cognitive Abilities and Social Skills ]. Grada.
  • Ďuricová, D. (2023). Vplyv Snoezelen intervencie a Reminiscenčnej terapie na emocionalitu, úzkosť a agitované správanie seniorov v zariadení [The Effect of Snoezelen Intervention and Reminiscence Therapy on Emotionality, Anxiety, and Agitated Behavior in Seniors in a Care Facility ] [Master's Thesis, Matej Bel University].CRZP.
  • Cohen-Mansfield, J. (1991). Instruction Manual for the Cohen-Mansfield Agitation Inventory (CMAI). The Research Institute of the Hebrew Home of Greater Washington.
  • Ruisel, I., Müllner, J., & Farkaš, G. (1980). Dotazník na meranie úzkosti a úzkostlivosti [Questionnaire for measuring anxiety and anxiousness]. Psychodiagnostika, spoločnosť s. r. o.
  • Džuka, J., & Dalbert, C. (2002). Vývoj a overenie validity škál emocionálnej habituálnej subjektívnej pohody (SEHP) [Development and validation of the scales of emotional habitual subjective well-being]. Československá psychologie, 46(3), 234-250.

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09I03-03-V05-00009 (Other Grant/Funding Number: Early stage grants - Matej Bel University in Banská Bystrica)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The informed consent form will be shared.

IPD Sharing Time Frame

The informed consent form will be shared without restriction.

IPD Sharing Access Criteria

Everyone will have access to the informed consent form.

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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