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Completed

NCT Number: NCT06725251

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advocate Memory Center

Park Ridge, Illinois, 60068, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Art Therapy

Behavioral

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.

Primary outcomes

  1. Impact of Art Therapy on Quality of Dyadic Relationship

    Time frame: Week 1

    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).

  2. Impact of Art Therapy on Quality of Dyadic Relationship

    Time frame: Week 4

    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).

Secondary outcomes

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

    Time frame: Week 1

    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.

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

    Time frame: Week 4

    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.

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

    Time frame: Week 1

    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.

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

    Time frame: Week 4

    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.

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

    Time frame: Week 1

    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.

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

    Time frame: Week 4

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • James R. and Helen D. Russell Center for Research and Innovation

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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