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 40 participants.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

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

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Completed
Last Updated

August 7, 2026

Status Verified

August 1, 2026

Enrollment Period

10 months

First QC Date

October 11, 2024

Last Update Submit

August 4, 2026

Conditions

Keywords

CognitionPerceptionAgedHealthy VolunteersLearning

Outcome Measures

Primary Outcomes (8)

  • Acceptability - Age appropriateness

    Perceived age-appropriateness of the course content, likert scale 0-5

    Throughout training (weeks 1-6 of training)

  • Acceptability - engagement

    Level of engagement with the course materials, likert scale 0-5

    Throughout training (weeks 1-6 of training)

  • Acceptability - Welcoming

    How welcoming participants perceived the activities, likert scale from 0-5

    Throughout training (weeks 1-6 of training)

  • Feasibility - completion rate

    % of participants who completed both testing sessions

    At the post-test 6-8 weeks later

  • Feasibility - adherence

    Number of lessons that participants completed, from 0-6

    At the post-test 6-8 weeks later or when a participant decided to drop out

  • Feasibility - Frequency

    Total number of times participants logged their progress

    Throughout training (weeks 1-6 of training)

  • Feasibility - Attrition

    List of common reasons for drop-out and the number of times a reason was mentioned

    At the post-test 6-8 weeks later or when a participant decided to drop out

  • Change in Drawing skills

    Participants will have 7 minutes to draw a still life from observation. Accuracy is scored using a rubric assessing accuracy on global and local features.

    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 - flow

    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

* Learning about and practicing drawing from observation with training adding up to 2 hours 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

You may not qualify if:

  • Formal diagnosis of dementia or other neurological disease, including Mild Cognitive Impairment
  • 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

Location

Study Officials

  • Susanne Jaeggi, PhD

    Northeastern University

    PRINCIPAL INVESTIGATOR
  • Aaron Seitz, PhD

    Northeastern University

    PRINCIPAL INVESTIGATOR

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

July 31, 2026

Study Completion

September 30, 2026

Last Updated

August 7, 2026

Record last verified: 2026-08

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