Clinical trial NCT06645652: Visual Arts Interventions With Older Adults
Official title: Feasibility and Preliminary Effects of a Drawing-based Intervention on Cognition and Wellbeing of Community-Dwelling Adults at Risk for ADRD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Feasibility Study
Keywords: Cognition
Perception
Aged
Healthy Volunteers
Learning
Lead sponsor: Northeastern University
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability - clarity
timeFrame: Throughout training and post-test 6-8 weeks later
measure: Acceptability - engagement
timeFrame: Throughout training and post-test 6-8 weeks later
measure: Acceptability - value
timeFrame: Throughout training and post-test 6-8 weeks later
measure: Feasibility - completion rate
timeFrame: Throughout training and post-test 6-8 weeks later
measure: Feasibility - adherence
timeFrame: Throughout training and post-test 6-8 weeks later
measure: Feasibility - frequency
timeFrame: Throughout training and post-test 6-8 weeks later
measure: Feasibility - attrition
timeFrame: Throughout training and post-test 6-8 weeks later
measure: Change in Drawing skills
timeFrame: Pre-test (baseline) and post-test 6-8 weeks later
Secondary outcomes:
measure: Change in Perception - contour integration
timeFrame: Pre-test (baseline) and post-test 6-8 weeks later
measure: Change in Perception - visual disembedding
timeFrame: Pre-test (baseline) and post-test 6-8 weeks later
measure: Change in Visuospatial Reasoning - construction and memory
timeFrame: Pre-test (baseline) and post-test 6-8 weeks later
measure: Change in Visuospatial Reasoning - mental transformation
timeFrame: Pre-test (baseline) and post-test 6-8 weeks later
measure: Change in Attention
timeFrame: Pre-test (baseline) and post-test 6-8 weeks later
measure: Change in Mindfulness
timeFrame: Pre-test (baseline) and post-test 6-8 weeks later
measure: Change in Mental Wellbeing
timeFrame: Pre-test (baseline) and post-test 6-8 weeks later
Other outcomes:
measure: Daily progress log
timeFrame: After every training session (weeks 1-6 of training, up to 7 times a week)
Locations:
Study officials:
affiliation: Northeastern University
name: Susanne Jaeggi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northeastern University
name: Aaron Seitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: