- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07498179
Activation-Socialization Intervention Program for Seniors
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
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Banská Bystrica, Slovakia, 974 11
- Office of the Higher Territorial Unit of Banská Bystrica
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Activation-socialization Interventiom Programme
The experimental group participates in an Activation-Socialization Intervention Program for five weeks.
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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).
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|
No Intervention: Control group
The control group does not participate in the intervention program.
|
What is the study measuring?
Primary Outcome Measures
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
|
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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).
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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.
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two months
|
Secondary Outcome Measures
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
|
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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.
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six months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Lenka Ďuricová, doc., Mgr., PhD., Matej Bel University
Publications and helpful links
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
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID 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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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