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NCT Number: NCT07498179

Activation-Socialization Intervention Program for Seniors

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.

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Key information

Age range

62 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Office of the Higher Territorial Unit of Banská Bystrica

Banská Bystrica, 974 11, Slovakia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activation and Socialization Intervention Program

Other

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).

Primary outcomes

  1. 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).

  2. 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).

  3. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

Diana Ďuricová

Other

Collaborators

  • European Union

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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