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Clinical Trials/NCT06725251
NCT06725251CompletedNot Applicable

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

Wake Forest University Health Sciences1 site in 1 country82 target enrollmentStarted: August 26, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
82
Locations
1
Primary Endpoint
Impact of Art Therapy on Quality of Dyadic Relationship

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Dementia Participants and Care Partners

Experimental

Dyads including a participant diagnosed with dementia and the care partner

Intervention: Art Therapy (Behavioral)

Outcomes

Primary Outcomes

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).

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).

Secondary Outcomes

  • Impact of Art Therapy on Dementia Individuals' Self-esteem(Week 4)
  • Impact of Art Therapy on Dementia Individuals' Sense of Stigma(Week 4)
  • Impact of Art Therapy on Care Partner Attitudes Towards Persons with Dementia(Week 4)
  • Impact of Art Therapy on Dementia Individuals' Self-esteem(Week 1)
  • Impact of Art Therapy on Dementia Individuals' Sense of Stigma(Week 1)
  • Impact of Art Therapy on Care Partner Attitudes Towards Persons with Dementia(Week 1)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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