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CompletedNCT06725251Updated Dec 10, 2024

The Impact of Art Therapy on the Relationships Between Individuals Diagnosed With Alzheimer's Disease and Their Care Partners

An interventional study of Art Therapy in Dementia, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-10.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 8 years 3 months after the study started (first participant enrolled Aug 2016, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the impact of a 4-week art therapy intervention on the relationships between individuals diagnosed with Alzheimer's disease and their care partners, on the self-esteem of diagnosed individuals, and on care partner attitudes towards persons with Alzheimer's disease.

Read the detailed description

The aim is to develop and implement an art therapy intervention for dyads - each consisting of an individual diagnosed with mild Alzheimer's disease and his/her care partner - with the goals of improving patients' and care partners' sense of their relationship, increasing patients' self-esteem and improving care partner attitudes towards individuals with Alzheimer's disease. The specific intervention will be a portrait-making project utilizing a collage approach. Each participant (i.e. diagnosed individuals and care partners) will be instructed to create a portrait of him/herself. Participants will be provided with a sample portrait as well as bins of materials (e.g. words, images, markers). The intervention will be administered for 1 ½ hours weekly, at the same day/time, for 4 consecutive weeks.

02

Conditions studied

  • Dementia

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Keywords

  • self esteem
  • caregiver
  • art therapy
03

In context

Dementia

2,231 studies on the registry are indexed under Dementia; 549 are open to participants now.

This study's enrollment of 82 is close to the median of 83 across 1,669 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 199 are open to participants now.

Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion criteria for patients include:

  • A diagnosis of Alzheimer's disease, based on the NIA/AA Diagnostic Guidelines for Alzheimer's Disease (McKhann et al., 2011)
  • MMSE of 18-26, inclusive, administered within 6 month prior to screening or at screening
  • Awareness of diagnosis and/or memory impairment, as determined by semi-structured interview with clinician (see Appendix B)
  • Availability and willingness to participate in all 4 sessions of the intervention
  • A care partner with whom the patient has regular weekly contact and who is available and willing to participate in all 4 sessions of the intervention
  • Sufficient visual acuity to read 12-point font
  • Sufficient manual dexterity to use scissors
  • Ability to hear instructions in a classroom setting
  • Ability to read English
  • Age 18 years old or greater

Exclusion criteria for patients include:

  • Any uncontrolled medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause of the subject's cognitive impairment (e.g., substance abuse, vitamin B12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, Lewy body dementia, fronto-temporal dementia, head trauma).
  • Current active psychiatric illness (e.g., major depression, schizophrenia, etc.)
  • Current active seizure disorder.
  • Malignancy or carcinoma currently requiring active treatment or progressing off of treatment.
  • Recent history (within 1 year) of alcohol abuse or drug abuse.
  • Active tobacco use that interferes with visits (e.g., if the patient would need to smoke during the therapy session).
  • Use of medications (e.g., narcotics, sedatives, etc.) that lead to drowsiness during the therapy sessions
  • Inability to comply with the instructions of the art therapist.
  • Other unspecified reasons that, in the opinion of the Investigator make the subject unsuitable for enrollment.
  • Prisoners

Inclusion criteria for care partners include:

  • Adult 18 years of age or older
  • Ability to consent
  • Regular weekly contact with the subject diagnosed with Alzheimer's disease
  • Availability and willingness to participate in all 4 sessions of the intervention
  • Sufficient visual acuity to read 12-point font
  • Sufficient manual dexterity to use scissors
  • Ability to hear instructions in a classroom setting
  • Ability to read English

Exclusion criteria for care partners include:

  • Any uncontrolled medical or neurological/neurodegenerative condition sufficient to cause cognitive impairment
  • Current active psychiatric illness (e.g., major depression, schizophrenia, etc.)
  • Current active seizure disorder.
  • Malignancy or carcinoma currently requiring active treatment or progressing off of treatment.
  • Recent history (within 1 year) of alcohol abuse or drug abuse.
  • Active tobacco use that interferes with visits (e.g., if the care partner would need to smoke during the therapy session).

Use of medications (e.g., narcotics, sedatives, etc.) that lead to drowsiness during the therapy sessions

  • Inability to comply with the instructions of the art therapist.
  • Other unspecified reasons that, in the opinion of the Investigator make the care partner unsuitable for enrollment.
  • Prisoners
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Dementia Participants and Care Partners

    Dyads including a participant diagnosed with dementia and the care partner

    Behavioral: Art Therapy

Interventions

  • BehavioralArt Therapy

    Dyads will take part in a portrait-making project utilizing a collage approach. Each participant (i.e. dementia diagnosed individuals and care partners) will be instructed to create a portrait of him/herself. Participants will be provided with a sample portrait as well as bins of materials. \]The intervention will be administered for 1 ½ hours weekly, at the same day/time, for 4 consecutive weeks.

06

What researchers measure

Primary outcomes

  1. Impact of Art Therapy on Quality of Dyadic Relationship

    Impact of art therapy on quality of dyadic relationship will be determined using the Dyadic Relationship Scale. The survey consists of 10 questions with a total score range of 10-40. The score is a measure of patient and care partner perceptions of their relationship. Lower scores indicate the perception of a poorer relationship (i.e. greater strain, lower positive interactions) and higher scores indicate a perceived better relationship (i.e. lower strain, greater positive interactions).

    Time frame: Week 1

  2. Impact of Art Therapy on Quality of Dyadic Relationship

    Impact of art therapy on quality of dyadic relationship will be determined using the Dyadic Relationship Scale. The survey consists of 10 questions with a total score range of 10-40. The score is a measure of patient and care partner perceptions of their relationship. Lower scores indicate the perception of a poorer relationship (i.e. greater strain, lower positive interactions) and higher scores indicate a perceived better relationship (i.e. lower strain, greater positive interactions).

    Time frame: Week 4

Secondary outcomes

  1. Impact of Art Therapy on Dementia Individuals' Self-esteem

    The impact of art therapy on the dementia diagnosed individuals' self-esteem will be determined by the Rosenberg Self-Esteem Scale. The survey consists of 10 questions with a total score range of 0-30. The score is a measure of patient self-esteem, with lower scores meaning lower self-esteem and higher scores meaning higher self-esteem.

    Time frame: Week 1

  2. Impact of Art Therapy on Dementia Individuals' Self-esteem

    The impact of art therapy on the dementia diagnosed individuals' self-esteem will be determined by the Rosenberg Self-Esteem Scale. The survey consists of 10 questions with a total score range of 0-30. The score is a measure of patient self-esteem, with lower scores meaning lower self-esteem and higher scores meaning higher self-esteem.

    Time frame: Week 4

  3. Impact of Art Therapy on Dementia Individuals' Sense of Stigma

    The impact of art therapy on diagnosed individuals' sense of stigma will be determined by the Stigma Impact Scale. The survey consists of 20 questions with a total score range of 0-80. The score is a measure of the patient's perception of stigma, with lower scores indicating lower perceived stigma and higher scores indicating greater perceived stigma.

    Time frame: Week 1

  4. Impact of Art Therapy on Dementia Individuals' Sense of Stigma

    The impact of art therapy on diagnosed individuals' sense of stigma will be determined by the Stigma Impact Scale. The survey consists of 20 questions with a total score range of 0-80. The score is a measure of the patient's perception of stigma, with lower scores indicating lower perceived stigma and higher scores indicating greater perceived stigma.

    Time frame: Week 4

  5. Impact of Art Therapy on Care Partner Attitudes Towards Persons with Dementia

    The impact of art therapy on care partner attitudes towards persons with dementia will be determined by the Dementia Attitudes Scale. The survey consists of 20 questions with a total score range of 20-140. The score is a measure of care partner attitudes towards patients with dementia. Lower scores indicate lower knowledge and social comfort with persons with dementia and a higher score indicates greater knowledge and social comfort with persons with dementia.

    Time frame: Week 1

  6. Impact of Art Therapy on Care Partner Attitudes Towards Persons with Dementia

    The impact of art therapy on care partner attitudes towards persons with dementia will be determined by the Dementia Attitudes Scale. The survey consists of 20 questions with a total score range of 20-140. The score is a measure of care partner attitudes towards patients with dementia. Lower scores indicate lower knowledge and social comfort with persons with dementia and a higher score indicates greater knowledge and social comfort with persons with dementia.

    Time frame: Week 4

07

Study locations

1 site
  • Advocate Memory Center
    Park Ridge, Illinois 60068, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2016 to primary completion in Aug 2022, 71 months.

Of 835 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 71 months is above that.

Counting every sponsor, half of 875 studies reached it within 24 months; a quarter within 11 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2024
First posted
Dec 10, 2024
StartActual
Aug 26, 2016
Primary completionActual
Aug 2, 2022
CompletionActual
Aug 2, 2022
Last update
Dec 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06725251
Collaborators
James R. and Helen D. Russell Center for Research and Innovation
Responsible party
Sponsor
First posted
Dec 10, 2024
Start date
Aug 26, 2016
Primary completion
Aug 2, 2022
Completion
Aug 2, 2022
Last update
Dec 10, 2024

Study contacts

Darren Gitelman, MD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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