An interventional study of Activation and Socialization Intervention Program in Healthy, sponsored by Diana Ďuricová. Enrolling by invitation at 1 site in Slovakia. Open to participants aged 62 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Diana Ďuricová · Not applicable, Interventional, and Supportive care
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.
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:
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Diana Ďuricová is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria for elderly adults:
The experimental group participates in an Activation-Socialization Intervention Program for five weeks.
Other: Activation and Socialization Intervention Program
The control group does not participate in the 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).
The Scale of Emotional Habituation of Subjective Well-Being - SEHP (Džuka & Dalbert, 2002)
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).
Time frame: two months
The Anxiety and Trait Anxiety Inventory - STAI (Spielberger et al., 1970, ed. Ruisel et al., 1980)
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).
Time frame: two months
Cohen-Mansfield Agitation Inventory - CMAI (Cohen-Mansfield, 1991), specifically CMAI-D, long version.
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.
Time frame: two months
Reflection Questionnaire (Ďuricová, 2023)
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.
Time frame: six weeks
The Scale of Emotional Habituation of Subjective Well-Being - SEHP (Džuka & Dalbert, 2002)
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).
Time frame: six months
The Anxiety and Trait Anxiety Inventory - STAI (Spielberger et al., 1970, ed. Ruisel et al., 1980)
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).
Time frame: six months
Cohen-Mansfield Agitation Inventory - CMAI (Cohen-Mansfield, 1991), specifically CMAI-D, long version.
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.
Time frame: six months
Plan to share: Yes — The informed consent form will be shared.
Supporting information: Icf
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Diana Ďuricová