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HealthyNCT07498179

Activation-Socialization Intervention Program for Seniors

A study testing Activation and Socialization Intervention Program in people with Healthy, run by Diana Ďuricová at 1 site in Slovakia.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 62 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Activation and Socialization Intervention Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSlovakia
Study dates
20 Apr 2026to 1 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 62 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Slovakia1 site

  • Office of the Higher Territorial Unit of Banská Bystrica

    Banská Bystrica, 974 11

Other trials in Slovakia

About this study

Official title: 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.

Read the 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
Conditions
Healthy
Being tested
Activation and Socialization Intervention Program
Keywords
elderly adult, intervention, emotionality, anxiety, agitated behavior
Medical subject headings
Anxiety Disorders, Psychomotor Agitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Activation and Socialization Intervention ProgramOther

    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).

Study groups in NCT07498179
Study groupRoleWhat they receive
Activation-socialization Interventiom ProgrammeExperimentalThe experimental group participates in an Activation-Socialization Intervention Program for five weeks.
Receives: Other: Activation and Socialization Intervention Program
Control groupNo interventionThe control group does not participate in the intervention program.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: two months

  2. 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).

    Measured: two months

  3. 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.

    Measured: two months

Secondary outcomes (4)

  1. 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.

    Measured: six weeks

  2. 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).

    Measured: six months

  3. 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).

    Measured: six months

  4. 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.

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start20 Apr 2026 (estimated)
  3. Primary completion25 May 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07498179
Sponsor's protocol ID
09I03-03-V05-00009
Other IDs
09I03-03-V05-00009
Status last verified
Apr 2026
First submitted
23 Mar 2026
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The informed consent form will be shared.

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.

Questions about this trial

What is this clinical trial studying?

A study testing Activation and Socialization Intervention Program in people with Healthy, run by Diana Ďuricová at 1 site in Slovakia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Scale of Emotional Habituation of Subjective Well-Being - SEHP (Džuka & Dalbert, 2002) (time frame: two months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07498179, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

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