Emotional StatesNCT06866015
Activation Programme's Impact on Seniors' Emotionality and Loneliness
A study testing Activation-socialization intervention programme in people with Emotional States and Loneliness, run by Diana Ďuricová at 1 site in Slovakia.
Trial summary
The goal of this pilot study is to verify the short-term effectiveness of the Activation-Socialisation Intervention Programme (A-S IP) on the psychosocial survival of older adults in a specific care facility. Read more about this study
- Who is it for?
- Ages 62 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emotional States, Loneliness, Seniors
- What is being tested?
- Activation-socialization intervention programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSlovakia
- Study dates
- 4 Feb 2021to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- long-term residence in the facility,
- age over 62,
- willingness to participate,
- ability to participate (no severe cognitive or physical impairments)
Who cannot join
- significant physical problems,
- significant mental health problems,
- unwillingness to participate
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
Hriňovčan care facility for older adults
Hriňová, Slovakia, 96205
About this study
Official title: The Impact of an Activation-Socialisation Intervention Programme on the Emotionality and Loneliness of Older Adults in Slovak Elderly Care Facilities - a Pilot Study
The goal of this pilot study is to verify the short-term effectiveness of the Activation-Socialisation Intervention Programme (A-S IP) on the psychosocial survival of older adults in a specific care facility. The main questions it aims to answer are:
- Does the A-S IP reduce the rate of negative emotional states in older adults?
- Does the A-S IP increase the rate of positive emotional states in older adults?
- Does the A-S IP reduce feelings of loneliness in older adults? Researchers will compare the experimental group (older adults participating in the A-S IP) to a control group (older adults not participating in the intervention) to assess the impact on emotional states and loneliness.
Read more
Participants will:
- Participate in 40 activities based on three domains (Laughter Therapy, Reminiscence Therapy, and Cognitive and Social Skills Stimulation)
- Engage in group activities for four weeks, with daily sessions scheduled in the morning and afternoon
- Provide feedback on their experiences through surveys and questionnaires to assess their emotional states and satisfaction with the intervention
The study will also explore whether the intervention contributes to the well-being of older adults, as measured by changes in their emotional states and feelings of loneliness.
Read the detailed description
The study was registered retrospectively due to limited awareness of the registration requirement for behavioral interventions at the time of study initiation (in 2021). Initially, the research was designed as an exploratory study on a smaller scale, and the registration of a formal trial was not considered necessary.
As an early-career researcher and doctoral student, I was not initially aware of the necessity of registering behavioral intervention studies. However, as the study progressed and its significance became evident, I came to understand the importance of this process. Once I became aware of the registration requirements, I took the necessary steps to complete it accordingly.
Despite the late registration, the study was conducted according to a pre-specified protocol, with all methodological and ethical standards strictly adhered to (approved, for example, by the Ethics Committee of UMB). The hypotheses, study design, and analysis plan were defined prior to data collection, ensuring the integrity and transparency of the research.
- Conditions
- Emotional States, Loneliness, Seniors
- Being tested
- Activation-socialization intervention programme
- Keywords
- older adult, elderly care facilities, intervention programme, emotions, loneliness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activation-socialization intervention programmeOther
The proposed A-S IP (Author, 2021) includes 40 activities of three domains focusing mainly on the social-psychological level of education: the Laughter Therapy Concept (13), the Reminiscence Therapy Concept (13), and the Cognitive and Social Skills Stimulation Intervention Concept (14).
The implementation of the A-S IP activities was designed for a time period of four weeks during weekdays. In the Hriňovčan care facility for older adults, mainly in the common room, two activities were implemented daily during the morning and afternoon hours reserved for this purpose. Morning activities (active) were from 10:00 to 11:00 a.m., and afternoon activities (passive) were from 1:00 to 2:00 p.m. The application of the activities was strictly determined and organised according to a time-thematic schedule that applied rules. The participants participated in group activities, and their participation was voluntary.
| Study group | Role | What they receive |
|---|---|---|
| Activation-socialization interventiom programme | Experimental | Not described Receives: Other: Activation-socialization intervention programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Scale of Emotional Habitual 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). An additional variable, loneliness, was added to the scale. It was assessed on an identical six-point scale.
Unit of Measure: Score (Total score for positive and negative emotions)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start4 Feb 2021
- Primary completion8 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional StatesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diana Ďuricová
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diana Ďuricová, Matej Bel University
- Investigators
- Diana Ďuricová, PhDr., Principal investigator, Matej Bel UniversityLenka Ďuricová, doc., Mgr., PhD., Study director, Matej Bel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866015
- Sponsor's protocol ID
- 162/2025
- Status last verified
- Mar 2025
- First submitted
- 24 Feb 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an Activation-Socialisation Intervention Programme on the Emotionality and Loneliness of Older Adults in Slovak Elderly Care Facilities - a Pilot Study
- ClinicalTrials.gov ID
- NCT06866015
- Acronym / sponsor ID
- 162/2025
- Conditions
- Emotional States, Loneliness, Seniors
- Keywords
- older adult, elderly care facilities, intervention programme, emotions, loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Diana ĎuricováUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to verify the short-term effectiveness of the Activation-Socialisation Intervention Programme (A-S IP) on the psychosocial survival of older adults in a specific care facility. The main questions it aims to answer are:
- Does the A-S IP reduce the rate of negative emotional states in older adults?
- Does the A-S IP increase the rate of positive emotional states in older adults?
- Does the A-S IP reduce feelings of loneliness in older adults? Researchers will compare the experimental group (older adults participating in the A-S IP) to a control group (older adults not participating in the intervention) to assess the impact on emotional states and loneliness.
Participants will:
- Participate in 40 activities based on three domains (Laughter Therapy, Reminiscence Therapy, and Cognitive and Social Skills Stimulation)
- Engage in group activities for four weeks, with daily sessions scheduled in the morning and afternoon
- Provide feedback on their experiences through surveys and questionnaires to assess their emotional states and satisfaction with the intervention
The study will also explore whether the intervention contributes to the well-being of older adults, as measured by changes in their emotional states and feelings of loneliness.
Detailed description
The study was registered retrospectively due to limited awareness of the registration requirement for behavioral interventions at the time of study initiation (in 2021). Initially, the research was designed as an exploratory study on a smaller scale, and the registration of a formal trial was not considered necessary.
As an early-career researcher and doctoral student, I was not initially aware of the necessity of registering behavioral intervention studies. However, as the study progressed and its significance became evident, I came to understand the importance of this process. Once I became aware of the registration requirements, I took the necessary steps to complete it accordingly.
Despite the late registration, the study was conducted according to a pre-specified protocol, with all methodological and ethical standards strictly adhered to (approved, for example, by the Ethics Committee of UMB). The hypotheses, study design, and analysis plan were defined prior to data collection, ensuring the integrity and transparency of the research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Activation-socialization interventiom programme | Experimental | Other: Activation-socialization intervention programme |
Who may qualify
- Ages
- 62 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- long-term residence in the facility,
- age over 62,
- willingness to participate,
- ability to participate (no severe cognitive or physical impairments)
Key exclusion criteria (3 listed)
- significant physical problems,
- significant mental health problems,
- unwillingness to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activation-socialization intervention programmeThe proposed A-S IP (Author, 2021) includes 40 activities of three domains focusing mainly on the social-psychological level of education: the Laughter Therapy Concept (13), the Reminiscence Therapy Concept (13), and the Cognitive and Social Skills Stimulation Intervention Concept (14). The implementation of the A-S IP activities was designed for a time period of four weeks during weekdays. In the Hriňovčan care facility for older adults, mainly in the common room, two activities were implemented daily during the morning and afternoon hours reserved for this purpose. Morning activities (active) were from 10:00 to 11:00 a.m., and afternoon activities (passive) were from 1:00 to 2:00 p.m. The application of the activities was strictly determined and organised according to a time-thematic schedule that applied rules. The participants participated in group activities, and their participation was voluntary. | Other | Activation-socialization interventiom programme |
Primary outcome
the Scale of Emotional Habitual Subjective Well-being - SEHP (Džuka & Dalbert, 2002)
Time frame: one month
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). An additional variable, loneliness, was added to the scale. It was assessed on an identical six-point scale. Unit of Measure: Score (Total score for positive and negative emotions)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- The anonymised datasetLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Ďuricová, PhDr. principal investigator
Matej Bel University
Lenka Ďuricová, doc., Mgr., PhD. study director
Matej Bel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activation-socialization intervention programme in people with Emotional States and Loneliness, 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 14 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Habitual Subjective Well-being - SEHP (Džuka & Dalbert, 2002) (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2025.