NCT06645652

Brief Summary

The present study investigates the feasibility, acceptability, and preliminary effects of a novel visual arts-based intervention in an older adult population. In a randomized controlled design, two arts-based interventions will be evaluated with a group of 50 participants.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Oct 2025Sep 2026

First Submitted

Initial submission to the registry

October 11, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
12 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

October 11, 2024

Last Update Submit

April 15, 2026

Conditions

Keywords

CognitionPerceptionAgedHealthy VolunteersLearning

Outcome Measures

Primary Outcomes (8)

  • Acceptability - clarity

    Perceived clarity on the course content, likert scale 1-5

    Throughout training and post-test 6-8 weeks later

  • Acceptability - engagement

    Level of engagement with the course materials, likert scale 1-5

    Throughout training and post-test 6-8 weeks later

  • Acceptability - value

    Perceived value of the course content, likert scale 1-5

    Throughout training and post-test 6-8 weeks later

  • Feasibility - completion rate

    % of participants who completed both testing sessions

    Throughout training and post-test 6-8 weeks later

  • Feasibility - adherence

    % of lessons that participants completed, from 0-6

    Throughout training and post-test 6-8 weeks later

  • Feasibility - frequency

    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

    Attrition reason: participants withdrawing will select from one of 5 options or 'other' to record the reason for withdrawing

    Throughout training and post-test 6-8 weeks later

  • Change in Drawing skills

    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.

    Pre-test (baseline) and post-test 6-8 weeks later

Secondary Outcomes (7)

  • Change in Perception - contour integration

    Pre-test (baseline) and post-test 6-8 weeks later

  • Change in Perception - visual disembedding

    Pre-test (baseline) and post-test 6-8 weeks later

  • Change in Visuospatial Reasoning - construction and memory

    Pre-test (baseline) and post-test 6-8 weeks later

  • Change in Visuospatial Reasoning - mental transformation

    Pre-test (baseline) and post-test 6-8 weeks later

  • Change in Attention

    Pre-test (baseline) and post-test 6-8 weeks later

  • +2 more secondary outcomes

Other Outcomes (1)

  • Daily progress log

    After every training session (weeks 1-6 of training, up to 7 times a week)

Study Arms (2)

Participatory Arts

EXPERIMENTAL

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.

Behavioral: Training in observational drawing

Receptive Arts

ACTIVE COMPARATOR

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.

Behavioral: Arts engagement through digital galleries

Interventions

* 6 weeks of online gallery browsing based on different topics * Daily practice drawing from observation with training adding up to 1 hour a week * Documenting progress and reflection writing

Participatory Arts

* 6 weeks of online gallery browsing based on different topics * 2 hours of weekly activities consist of reading and navigating technology * Reflection writing

Receptive Arts

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

RECRUITING

Study Officials

  • Susanne Jaeggi, PhD

    Northeastern University

    PRINCIPAL INVESTIGATOR
  • Aaron Seitz, PhD

    Northeastern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariya Vodyanyk, MA

CONTACT

Audrey Carrillo, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2024

First Posted

October 17, 2024

Study Start

October 1, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Intervention materials and individual participant data (anonymized)

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available persistently at the conclusion of the study.
Access Criteria
There are no access criteria.

Locations