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Enrolling by invitation NCT07498179

Activation-Socialization Intervention Program for Seniors

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Activation and Socialization Intervention Program.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: from 62 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovakia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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

Interventions

  • 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 o

Primary outcome measures

  • The Scale of Emotional Habituation of Subjective Well-Being - SEHP (Džuka & Dalbert, 2002) [Time frame: two months]
  • The Anxiety and Trait Anxiety Inventory - STAI (Spielberger et al., 1970, ed. Ruisel et al., 1980) [Time frame: two months]
  • Cohen-Mansfield Agitation Inventory - CMAI (Cohen-Mansfield, 1991), specifically CMAI-D, long version. [Time frame: two months]
Secondary outcome measures (4)
  • Reflection Questionnaire (Ďuricová, 2023) [Time frame: six weeks]
  • The Scale of Emotional Habituation of Subjective Well-Being - SEHP (Džuka & Dalbert, 2002) [Time frame: six months]
  • The Anxiety and Trait Anxiety Inventory - STAI (Spielberger et al., 1970, ed. Ruisel et al., 1980) [Time frame: six months]
  • Cohen-Mansfield Agitation Inventory - CMAI (Cohen-Mansfield, 1991), specifically CMAI-D, long version. [Time frame: six months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Slovakia · 1 center
  • Office of the Higher Territorial Unit of Banská Bystrica — Banská Bystrica

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.

Identifiers

NCT: NCT07498179 · 09I03-03-V05-00009 · 09I03-03-V05-00009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗