- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07933029
Dynamic Creative Arts Group Intervention to Alleviate Loneliness and Support Well-Being in Older Adults With Cognitive Changes (Dynamic-Arts)
Alleviating Loneliness, Preserving Well-Being and Quality of Life: Immediate and Long-Term Effects of a Dynamic Creative Arts Group Intervention for Older Adults With Subjective and Mild Cognitive Impairment
The goal of this study is to investigate whether a dynamic group intervention that combines conversation and creative arts can reduce loneliness and support well-being and quality of life among older adults experiencing subjective or mild cognitive impairment.
The study will also explore how participants connect with one another, express emotions, and develop relationships during the group sessions.
Fifty older adults aged 65 and older, with subjective or mild cognitive impairment, will take part in the study.
Participants will:
Attend 10-group sessions that combine open conversations combined with creative arts, such as art, music, movement, and drama. Group sessions will be video-recorded to help researchers study participants' interactions and processes in the group.
Complete questionnaires about loneliness, well-being, and quality of life at Baseline, Pre, Post the intervention and follow-up.
Answering questions about how they feel before and after selected sessions.
Participate in an interview and share their experiences of participating in the group.
Researchers will also observe group interactions to better understand how relationships and emotional expression develop during the sessions.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Older adults experiencing early cognitive decline may face challenges that go beyond memory difficulties. Changes in word-finding, communication, and thinking may affect their confidence, social participation, and relationships with others. Some may feel embarrassed, become less involved in social activities, or find it difficult to share their concerns and emotions. These experiences may contribute to loneliness and reduced psychological well-being and quality of life.
At this early stage of cognitive decline, many older adults continue to live independently and maintain their everyday activities. However, they may experience uncertainty about the changes they notice and worry about the future. Opportunities for meaningful relationships, emotional expression, and a sense of belonging may be especially important during this period.
Most existing interventions for older adults with subjective or mild cognitive impairment focus on maintaining or improving cognitive abilities. Less attention has been given to their emotional and interpersonal needs, particularly the need to share personal experiences, feel understood, and develop meaningful connections with others.
A dynamic group intervention may provide an opportunity to address these needs through sharing emotions, exploring interpersonal relationships, and interacting with others in the here and now. However, difficulties with verbal expression and reflection may make participation in traditional dynamic groups challenging for some older adults with cognitive decline.
Integrating creative arts into a dynamic group offers additional ways to communicate, express emotions, and connect with others. Visual art, music, movement, and drama can support participation without relying solely on words. The creative activities are not the main therapeutic focus but serve as a way to encourage emotional expression, shared experiences, and interpersonal connections.
Study Design and Procedures
The study uses a repeated-measures design without a separate control group. Fifty participants will take part in five rounds of groups with ~10 participants per group.
Assessments will take place at four time points: baseline, approximately one month before, pre-intervention, post-intervention and follow-up, four weeks later.
The period before the intervention will serve as a comparison period to examine changes that occur without the group intervention.
Immediate psychological well-being will also be assessed before and after sessions # 2, 4, 7, and 9.
Understanding Emotional and Interpersonal Processes In addition to examining changes in loneliness, psychological well-being, and quality of life, the study will explore how participants engage with others and express emotions during the group sessions.
All sessions will be video-recorded. Selected video segments will be analyzed to identify emotional behaviors and interpersonal interactions, including facial expressions, tone of voice, gestures, body movements, and verbal communication.
The study will also examine group engagement and perceived group support, and explore whether these processes are associated with changes in loneliness and psychological well-being.
Participants' Experiences Following the intervention, individual interviews will explore participants' experiences, including meaningful moments, relationships with other group members, emotional expression, and feelings of belonging.
The study aims to better understand not only whether this intervention can support older adults with early cognitive decline, but also how emotional expression and interpersonal connections may contribute to their well-being.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Noga Avni Orenstein, Doctoral student
- Telefonnummer: +972544433773
- E-mail: nogaavni@gmail.com
Undersøgelse Kontakt Backup
- Navn: Debbie Rand, Prof.
- Telefonnummer: +972549490715
- E-mail: drand@tauex.tau.ac.il
Studiesteder
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Kfar Saba, Israel
- Azar Savion Day Center
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Kontakt:
- Efrat Occupational Therapiest, BA
- Telefonnummer: +972526403186
- E-mail: eg@savionkfs.org
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- age 65 or older
- who live in the community
- independent or need only supervision in basic activities of daily living
- with sufficient communicative and expressive abilities in Hebrew to allow them to participate in the group.
- with intact or corrected hearing and vision
- With Subjective or Mild Cognitive Impairment.
- scorse in the Montreal Cognitive Assessment (MoCA) 20 and above.
Exclusion Criteria:
1) Participants with scores ≤ 19 in the MoCA, will not be included.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Dynamic Creative Arts Group Intervention
The intervention consists of 10 sessions, held twice a week, in closed groups of 8-10 older adults with subjective or mild cognitive impairment. Each session lasts 90 minutes and includes an opening check-in, a warm-up activity, a semi-structured creative activity followed by dynamic group discussion, and a closing ritual. Creative arts, including visual art, music, movement, and drama, are used to support emotional expression and interpersonal connections. Sessions address personal identity, meaningful relationships, family, life experiences, group belonging, and separation. The facilitator encourages participants to share experiences, explore emotions, respond to one another, and reflect on relationships within the group. The intervention emphasizes here-and-now interactions, mutual support, and the development of meaningful connections. |
A dynamic group intervention integrating creative arts for older adults with subjective or mild cognitive impairment. The intervention includes 10 sessions, held twice weekly, lasting 90 minutes each. Sessions combine group discussions with visual art, music, movement, and drama. The therapeutic focus is on here-and-now interactions, emotional expression, interpersonal learning, and the development of meaningful relationships. Creative activities provide additional verbal and nonverbal ways to communicate, share experiences, and connect with others. The facilitator encourages mutual support, reflection, and a sense of belonging within the group.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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changes in scores of the Three-Item Loneliness Scale
Tidsramme: Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up
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Perceived loneliness will be assessed using the Three-Item Loneliness Scale . The scale measures how often participants feel a lack of companionship, left out, or isolated from others. Each item is rated on a 3-point scale (1 = Hardly Ever, 2 = Some of the Time, 3 = Often). Total scores range from 3 to 9, with higher scores indicating greater perceived loneliness. The questions will be read aloud to participants. |
Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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changes in the lubben social network scale
Tidsramme: Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up
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Social interaction will be measured by the Lubben Social Network Scale . This is a short measure of social isolation and perceived social support in older adults . It includes three items assessing kinship (family) ties and three items of nonkin (friendship) ties. Scores range from 0-30. A clinical cut off score of less than 12 indicates risk for social isolation. |
Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up
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changes in the Actual social interaction
Tidsramme: Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up
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A non-formal observation will focus on actual social interaction of the participants. Verbal and nonverbal behaviors, engagement with other members of the center or staff will be considered Social interaction. |
Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up
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changes in the Positive and Negative Affect Schedule short form
Tidsramme: Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up
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A 10 item self-report measure of positive and negative affect, representing the affective component of subjective well-being. Items are rated from 1-never to 5-always, with separate scores for positive and negative affect (range: 5-25), with higher scores indicating greater levels of the specific affect. |
Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up
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changes in Satisfaction With Life Scale
Tidsramme: Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up
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The Satisfaction With Life Scale is a self-report measure, assessing global life satisfaction. Each of the 5 items is rated on a 7 point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree), total scores range from 5-35, higher scores indicate better life satisfaction. |
Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up
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changes in the utilization of health services
Tidsramme: Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up
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The number of doctor visits or general visits to primary care clinic within the last two weeks (collected by self-report ). |
Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up
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changes in the Subjective Health Rating
Tidsramme: Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up
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The question asked is: "In general, would you say your health is: excellent/very good/good/fair/poor?". This single item, self-rated, health measure is widely used in older adults studies and has demonstrated strong validity. |
Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up
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changes in the Bath Assessment of Subjective Quality of Life in Dementia
Tidsramme: Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up
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Subjective quality of life will be assessed using the Bath Assessment of Subjective Quality of Life in Dementia . This 14-item self-report questionnaire assesses two domains: life satisfaction and feelings of positive quality of life. Items are rated on a 5-point scale from 0 to 4. Scores are transformed to a 0-100 scale, with higher scores indicating better subjective quality of life. |
Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up
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changes in the immediate psychological wellbeing
Tidsramme: The intervention will include 10 group sessions, each session 60-90 minutes long, (twice a week). Outcome will be measured before and after sessions 2, 4, 7 and 9 .
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The Canterbury Wellbeing Scale is a short, self-report, visual analogue scale to assessing subjective wellbeing 'in the moment' of people with cognitive decline. It consists of five subscales (happy/sad, well/unwell, interested/bored, confident/not confident, optimistic/not optimistic) rated 0-100, with a total score ranging from0 to 500). Higher scores means better wellbeing. |
The intervention will include 10 group sessions, each session 60-90 minutes long, (twice a week). Outcome will be measured before and after sessions 2, 4, 7 and 9 .
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changes in the perceived Group Processes
Tidsramme: The intervention will include 10 group sessions, each session 60-90 minutes long (twice a week). Outcome will be measured after sessions 2, 4, 7 and 9.
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Perceived group processes will be assessed using a 7-item questionnaire developed for this study, based on existing measures of group cohesion, therapeutic alliance, and Yalom's therapeutic factors in group psychotherapy. The questionnaire assesses participants' perceptions of relationships with other group members and the facilitator, emotional sharing, interpersonal learning, and sense of belonging. Each item is rated on a 5-point agreement scale, from strongly disagree (1) to strongly agree (5). Higher scores indicate more positive perceptions of group processes. |
The intervention will include 10 group sessions, each session 60-90 minutes long (twice a week). Outcome will be measured after sessions 2, 4, 7 and 9.
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Demographic and functional data
Tidsramme: Baseline
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A study-specific questionnaire will collect demographic and functional information, including age, sex, country of birth, marital status, education, living arrangements, and previous occupation. Additional questions address self-reported vision, hearing, mobility, independence in basic activities of daily living, and using formal care support. Two questions assess subjective memory decline and related concerns. |
Baseline
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The Montreal Cognitive Assessment
Tidsramme: baseline
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The assessment will be used as an objective cognitive screening tool; scores of 26 and above will indicate Subjective Cognitive Impairment, whereas scores ranging from 19-25 will be considered Mild Cognitive Impairment and scores of 18 and below will be considered severe cognitive deficit. |
baseline
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Participant Satisfaction and Perceived Benefits of the Group Intervention
Tidsramme: At post-intervention (following completion of 10-sessions, each session 60-90 minutes long).
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Participant satisfaction and perceived benefits will be assessed using a questionnaire developed for this study. It includes 13 items rated on a 5-point scale, assessing overall satisfaction, comfort with emotional sharing, perceived changes in mood and confidence, sense of belonging, interpersonal connections, perceived reduction in loneliness, facilitator support, and the contribution of creative arts to emotional expression. Additional open-ended questions explore participants' experiences, preferences, and suggestions for improvement. |
At post-intervention (following completion of 10-sessions, each session 60-90 minutes long).
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
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Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0013191-2
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