Dynamic Creative Arts Group Intervention to Alleviate Loneliness and Support Well-Being in Older Adults With Cognitive Changes
NCT07933029, Not applicable, Not yet recruiting, Tel Aviv University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Dynamic Creative Arts Group Intervention to Alleviate Loneliness and Support Well-Being in Older Adults With Cognitive Changes | ClinicalTrials.gov |
| NCT number | NCT07933029 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Tel Aviv University | ClinicalTrials.gov |
| Conditions | Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI), Older Adults (65 Years and Older) | ClinicalTrials.gov |
| Interventions | Dynamic Creative Arts Group | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | changes in scores of the Three-Item Loneliness Scale | Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up | 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. | ClinicalTrials.gov |
| Secondary | changes in the lubben social network scale | Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up | 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. | ClinicalTrials.gov |
| Secondary | changes in the Actual social interaction | Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up | 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. | ClinicalTrials.gov |
| Secondary | changes in the Positive and Negative Affect Schedule short form | Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up | 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. | ClinicalTrials.gov |
| Secondary | changes in Satisfaction With Life Scale | Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up | 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. | ClinicalTrials.gov |
| Secondary | changes in the utilization of health services | Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up | The number of doctor visits or general visits to primary care clinic within the last two weeks (collected by self-report ). | ClinicalTrials.gov |
| Secondary | changes in the Subjective Health Rating | Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up | 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. | ClinicalTrials.gov |
| Secondary | changes in the Bath Assessment of Subjective Quality of Life in Dementia | Baseline, pre-intervention ( 4 weeks after Baseline), post-intervention (5 weeks later) - and 4-week follow-up | 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. | ClinicalTrials.gov |
| Secondary | changes in the immediate psychological 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 . | 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. | ClinicalTrials.gov |
| Secondary | changes in the perceived 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. | 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. | ClinicalTrials.gov |
| Other | Demographic and functional data | Baseline | 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. | ClinicalTrials.gov |
| Other | The Montreal Cognitive Assessment | baseline | 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. | ClinicalTrials.gov |
| Other | Participant Satisfaction and Perceived Benefits of the Group Intervention | At post-intervention (following completion of 10-sessions, each session 60-90 minutes long). | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)