- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06645652
Visual Arts Interventions With Older Adults
Feasibility and Preliminary Effects of a Drawing-based Intervention on Cognition and Wellbeing of Community-Dwelling Adults at Risk for ADRD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A two-arm randomized controlled study will be conducted to obtain within-group ratings of feasibility and acceptability, as well as between-group differences in drawing skills after training. In the drawing intervention, participants will learn and train drawing skills through exercises that target attention, perception, and visuospatial reasoning. In the active control condition, participants will navigate virtual art galleries. Both interventions will be completed remotely and at home. Participants will complete in-lab assessment sessions before and after the training.
Each intervention consists of 6 weeks of training for up to 2 hours a week, including up to 1 hour of a self-guided lesson and prompted daily drawing practice adding up to 1 hour in the drawing intervention and 2 1-hour sessions of virtual gallery exploring per week in the arts appreciation intervention. The pre-test is administered within one week of the start of training and the post-test is administered within one week of training completion.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mariya Vodyanyk, MA
- Phone Number: 608-628-4820
- Email: vodyanyk.m@northeastern.edu
Study Contact Backup
- Name: Audrey Carrillo, MA
- Email: a.carrillo@northeastern.edu
Study Locations
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-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Recruiting
- Northeastern University
-
Contact:
- Audrey Carrillo
- Phone Number: 626-482-8091
- Email: a.carrillo@northeastern.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 55-85 years of age
- Able to understand and speak English and follow study procedures
- Does not have a psychological or neurological condition that would prevent from being able to give consent to participate
- Less than 2 years of formal visual arts training
Exclusion Criteria:
- Formal diagnosis of dementia or other neurological disease, including Mild Cognitive Impairment
- A final score below 17 on the Montreal Cognitive Assessment - Blind (phone) version
- Abnormal visual acuity prohibitive of tablet-based training
- Physical handicap (motor or perceptual) that would impede training procedures
- Medical illness requiring treatment and/or significant absences during the study timeline
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participatory Arts
Participants will develop drawing skills through learning specific techniques and deliberately engaging cognitive domains such as perception, visuospatial reasoning, attention, and processing speed.
The intervention is completed in a hybrid format where lessons are completed online and practice is completed in a sketchbook and drawing things from life.
Prompts are provided to guide daily practice sessions.
Techniques learned include contour drawing, gesture drawing, negative space drawing.
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|
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Active Comparator: Receptive Arts
Participants will learn about different art periods and browse online galleries.
The materials will be available online through a website through which participants will access and browse online galleries.
Weekly topics include genres, subjects, or specific mediums.
Prompts and vocabulary will accompany the galleries to guide their learning.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability - clarity
Time Frame: Throughout training and post-test 6-8 weeks later
|
Perceived clarity on the course content, likert scale 1-5
|
Throughout training and post-test 6-8 weeks later
|
|
Acceptability - engagement
Time Frame: Throughout training and post-test 6-8 weeks later
|
Level of engagement with the course materials, likert scale 1-5
|
Throughout training and post-test 6-8 weeks later
|
|
Acceptability - value
Time Frame: Throughout training and post-test 6-8 weeks later
|
Perceived value of the course content, likert scale 1-5
|
Throughout training and post-test 6-8 weeks later
|
|
Feasibility - completion rate
Time Frame: Throughout training and post-test 6-8 weeks later
|
% of participants who completed both testing sessions
|
Throughout training and post-test 6-8 weeks later
|
|
Feasibility - adherence
Time Frame: Throughout training and post-test 6-8 weeks later
|
% of lessons that participants completed, from 0-6
|
Throughout training and post-test 6-8 weeks later
|
|
Feasibility - frequency
Time Frame: Throughout training and post-test 6-8 weeks later
|
Frequency: times a week that participants completed training, 0-7 for days practiced each week
|
Throughout training and post-test 6-8 weeks later
|
|
Feasibility - attrition
Time Frame: Throughout training and post-test 6-8 weeks later
|
Attrition reason: participants withdrawing will select from one of 5 options or 'other' to record the reason for withdrawing
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Throughout training and post-test 6-8 weeks later
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Change in Drawing skills
Time Frame: Pre-test (baseline) and post-test 6-8 weeks later
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Participants will have 5 minutes to draw a photograph.
Accuracy is scored using two methods: angle error at defined points of intersection and a rubric assessing accuracy on global and local features.
Both ratings are averaged into a composite z-score, as well as looked at separately.
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Pre-test (baseline) and post-test 6-8 weeks later
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Perception - contour integration
Time Frame: Pre-test (baseline) and post-test 6-8 weeks later
|
Participants tap on circles of aligned Gabors embedded in a scene of randomly oriented Gabors.
A circle will be present for 3 seconds and switch to the next trial if it is not seen.
Number of circles spotted, reaction times on spotted circle, and lowest level of alignment will be recorded.
Z-scores will be calculated.
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Pre-test (baseline) and post-test 6-8 weeks later
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Change in Perception - visual disembedding
Time Frame: Pre-test (baseline) and post-test 6-8 weeks later
|
Participants search for a target shape in 3 complex gestalts of overlapping shapes.
Participants select the complex shape containing the target.
Response times and accuracy are measured.
Z-scores will be calculated.
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Pre-test (baseline) and post-test 6-8 weeks later
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Change in Visuospatial Reasoning - construction and memory
Time Frame: Pre-test (baseline) and post-test 6-8 weeks later
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Complex Figures Copy and Recall will assess visuospatial construction and memory (10 min).
Participants will complete three sets of drawing complex shapes from observation and memory after a block of word learning.
Accuracy will be scored using a validated rubric.
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Pre-test (baseline) and post-test 6-8 weeks later
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Change in Visuospatial Reasoning - mental transformation
Time Frame: Pre-test (baseline) and post-test 6-8 weeks later
|
3D Mental Rotation (3 min) will test mental transformation.
Participants will be briefly shown two figures and asked to determine whether the figures are the same or mirror reversed.
Mean and SD reaction time per angular disparity and errors per angular disparity will be extracted.
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Pre-test (baseline) and post-test 6-8 weeks later
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Change in Attention
Time Frame: Pre-test (baseline) and post-test 6-8 weeks later
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A Rule switch task will measure set shifting.
Participants will sort shapes by color or shape.
Performance will be calculated as the response times on accurate switch trials.
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Pre-test (baseline) and post-test 6-8 weeks later
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Change in Mindfulness
Time Frame: Pre-test (baseline) and post-test 6-8 weeks later
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Participants complete a version Solloway Mindfulness Survey adapted to drawing.
The questionnaire includes 30 questions on a 7-point scale on the degree to which engaging in drawing is related to different aspects of mindful attention.
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Pre-test (baseline) and post-test 6-8 weeks later
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Change in Mental Wellbeing
Time Frame: Pre-test (baseline) and post-test 6-8 weeks later
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Mental Wellbeing is assessed by the WEMWBS, which includes 14 questions on a 5 point scale about positive mental wellbeing.
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Pre-test (baseline) and post-test 6-8 weeks later
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily progress log
Time Frame: After every training session (weeks 1-6 of training, up to 7 times a week)
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Participants will record the time spent and the content practiced during their sessions.
The survey includes selecting all the choices that apply, questions on a likert scale, and short response questions.
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After every training session (weeks 1-6 of training, up to 7 times a week)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susanne Jaeggi, PhD, Northeastern University
- Principal Investigator: Aaron Seitz, PhD, Northeastern University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NU-DS-20241011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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