Activation-Socialization Intervention Program for Seniors

NCT07498179 | Enrolling By Invitation

• 1 other identifier: 09I03-03-V05-00009
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy

Keywords

elderly adult; intervention; emotionality; anxiety; agitated behavior

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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.

  two months

Secondary Outcomes (4)

• Reflection Questionnaire (Ďuricová, 2023)

  six weeks

• The Scale of Emotional Habituation of Subjective Well-Being - SEHP (Džuka & Dalbert, 2002)

  six months

• The Anxiety and Trait Anxiety Inventory - STAI (Spielberger et al., 1970, ed. Ruisel et al., 1980)

  six months

• Cohen-Mansfield Agitation Inventory - CMAI (Cohen-Mansfield, 1991), specifically CMAI-D, long version.

  six months

Study Arms (2)

Activation-socialization Interventiom Programme

EXPERIMENTAL

The experimental group participates in an Activation-Socialization Intervention Program for five weeks.

Other: Activation and Socialization Intervention Program

Control group

NO INTERVENTION

The control group does not participate in the intervention program.

Interventions

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).

Activation-socialization Interventiom Programme

Eligibility Criteria

• Age: 62 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diana Ďuricová: lead
• European Union: collaborator

Study Sites (1)

Office of the Higher Territorial Unit of Banská Bystrica

Banská Bystrica, 974 11, Slovakia

Location

Related Publications (8)

• Spielberger, Ch. D., Gorsuch, R. L., & Lushene, R. E. (1970). Stai manual for the state trait anxiety inventory. Consulting Psychologists Press.

  BACKGROUND

• Ďuricová, D. (2026c). Aktivizačno-socializačný intervenčný program pre seniorov: Terapia smiechom [Activation-Socialization Intervention Program for Seniors: Laughter Therapy]. Grada.

  BACKGROUND

• Ďuricová, D. (2026b). Aktivizačno-socializačný intervenčný program pre seniorov: Reminiscenčná terapia [Activation-Socialization Intervention Program for Seniors: Reminiscence Therapy]. Grada.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Cohen-Mansfield, J. (1991). Instruction Manual for the Cohen-Mansfield Agitation Inventory (CMAI). The Research Institute of the Hebrew Home of Greater Washington.

  BACKGROUND

• Ruisel, I., Müllner, J., & Farkaš, G. (1980). Dotazník na meranie úzkosti a úzkostlivosti [Questionnaire for measuring anxiety and anxiousness]. Psychodiagnostika, spoločnosť s. r. o.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Lenka Ďuricová, doc., Mgr., PhD.

  Matej Bel University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctoral student

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: April 20, 2026
• Primary Completion: May 25, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: The informed consent form will be shared without restriction.
• Access Criteria: Everyone will have access to the informed consent form.

Locations

SL (1)