Clinical trial NCT06725251: The Impact of Art Therapy on the Relationships Between Individuals Diagnosed With Alzheimer's Disease and Their Care Partners
Official title: The Impact of Art Therapy on the Relationships Between Individuals Diagnosed With Alzheimer's Disease and Their Care Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: self esteem
caregiver
art therapy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: James R. and Helen D. Russell Center for Research and Innovation
First posted: 2024-12-10
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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

Primary outcomes:
measure: Impact of Art Therapy on Quality of Dyadic Relationship
timeFrame: Week 1
measure: Impact of Art Therapy on Quality of Dyadic Relationship
timeFrame: Week 4
Secondary outcomes:
measure: Impact of Art Therapy on Dementia Individuals' Self-esteem
timeFrame: Week 1
measure: Impact of Art Therapy on Dementia Individuals' Self-esteem
timeFrame: Week 4
measure: Impact of Art Therapy on Dementia Individuals' Sense of Stigma
timeFrame: Week 1
measure: Impact of Art Therapy on Dementia Individuals' Sense of Stigma
timeFrame: Week 4
measure: Impact of Art Therapy on Care Partner Attitudes Towards Persons with Dementia
timeFrame: Week 1
measure: Impact of Art Therapy on Care Partner Attitudes Towards Persons with Dementia
timeFrame: Week 4
Other outcomes:
Locations:
city: Park Ridge
country: United States
facility: Advocate Memory Center
state: Illinois
Study officials:
affiliation: Wake Forest University Health Sciences
name: Darren Gitelman, MD
role: PRINCIPAL_INVESTIGATOR
References: