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Not yet recruitingNCT07933029Dynamic-ArtsUpdated Nov 12, 2026

Dynamic Creative Arts Group Intervention to Alleviate Loneliness and Support Well-Being in Older Adults With Cognitive Changes

An interventional study of Dynamic Creative Arts Group in Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI) and Older Adults (65 Years and Older), sponsored by Tel Aviv University. Not yet recruiting at 1 site in Israel. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Tel Aviv University · Not applicable, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 54 studies in Cognitive Dysfunction with a site in Israel — 6 open to participants now, 8 under way, none of them phase 3. Cognitive Dysfunction · Israel.

Planned enrollment
16th of 34
50 · median 50
Started
2026
the only one that year
No phase
23 of 54
3 open now
Registered
54th of 54
by date
Lead sponsor
3 of 54
Tel Aviv University

Among the 54 studies in Cognitive Dysfunction with a site in Israel, this one is the 16th largest by planned enrollment of the 34 interventional ones that give a count, is the only one that started in 2026, is one of 23 with no phase, and was the 54th registered.

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

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Open to participants now

6 of the 54 studies in Cognitive Dysfunction with a site in Israel are open now. Recruiting first, the newest first:

All 6 open studies →

A study can be open while its sites in Israel have not opened yet or have stopped. Only those recruiting at a site in Israel →

Who these studies take

Of the 750 Cognitive Dysfunction studies recruiting now, 362 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 259 take healthy volunteers.

This study: 65 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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.

Read the detailed description

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.

03

Conditions studied

  • Subjective Cognitive Decline (SCD)
  • Mild Cognitive Impairment (MCI)
  • Older Adults (65 Years and Older)

Keywords

  • Dynamic group
  • Creative Arts
  • Cognitive Decline
  • Psychological Well-Being
  • Therapeutic Factors
04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. age 65 or older
  2. who live in the community
  3. independent or need only supervision in basic activities of daily living
  4. with sufficient communicative and expressive abilities in Hebrew to allow them to participate in the group.
  5. with intact or corrected hearing and vision
  6. With Subjective or Mild Cognitive Impairment.
  7. scorse in the (MoCA) 20 and above.

Exclusion criteria

Exclusion Criteria:

1) Participants with scores ≤ 19 in the , will not be included.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Dynamic Creative Arts Group

Interventions

  • BehavioralDynamic Creative Arts Group

    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.

    Also known as: Dynamic group with creative arts

06

What researchers measure

Primary outcomes

  1. changes in scores of the Three-Item Loneliness Scale

    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.

    Time frame: Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up

Secondary outcomes

  1. changes in the lubben social network scale

    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.

    Time frame: Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up

  2. changes in the Actual social interaction

    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.

    Time frame: Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up

  3. changes in the Positive and Negative Affect Schedule short form

    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.

    Time frame: Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up

  4. changes in Satisfaction With Life Scale

    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.

    Time frame: Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up

  5. changes in the utilization of health services

    The number of doctor visits or general visits to primary care clinic within the last two weeks (collected by self-report ).

    Time frame: Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up

  6. changes in the Subjective Health Rating

    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.

    Time frame: Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up

  7. changes in the Bath Assessment of Subjective Quality of Life in Dementia

    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.

    Time frame: Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up

  8. changes in the immediate psychological wellbeing

    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.

    Time frame: 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 .

  9. changes in the perceived Group Processes

    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.

    Time frame: 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.

Other outcomes

  1. Demographic and functional data

    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.

    Time frame: Baseline

  2. The Montreal Cognitive Assessment

    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.

    Time frame: baseline

  3. Participant Satisfaction and Perceived Benefits of the Group Intervention

    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.

    Time frame: At post-intervention (following completion of 10-sessions, each session 60-90 minutes long).

07

Study locations

1 site
  • Azar Savion Day Center
    Kfar Saba, Israel
    • Efrat Occupational Therapiest, BA · Contacteg@savionkfs.org · +972526403186
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for May 2028, 19 months later.

Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 19 months is below that.

Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 28, 2026
First posted
Nov 12, 2026
StartEst.
Oct 19, 2026
Primary completionEst.
May 2028
CompletionEst.
May 2028
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07933029
Responsible party
Debbie Rand (Full Professor, Department of Occupational Therapy, Gray Faculty of Medical and Health Sciences, Tel Aviv University) — Principal investigator
First posted
Nov 12, 2026
Start date
Oct 19, 2026 (estimated)
Primary completion
May 2028 (estimated)
Completion
May 2028 (estimated)
Last update
Nov 12, 2026

Study contacts

Noga Avni Orenstein, Doctoral student
Contact
nogaavni@gmail.com
+972544433773
Debbie Rand, Prof.
Contact
drand@tauex.tau.ac.il
+972549490715

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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