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

NCT ID: NCT06725251

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-26
• Study Completion Date: 2022-08-02

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.

Conditions

Dementia

Keywords

self esteem; caregiver; art therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Dementia Participants and Care Partners

Dyads including a participant diagnosed with dementia and the care partner

Group Type: EXPERIMENTAL

Art Therapy

Intervention Type: 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.

Interventions

Art 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Darren Gitelman, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Advocate Memory Center

Park Ridge, Illinois, United States

Countries

United States

Other Identifiers

6409

Identifier Type: OTHER

Identifier Source: secondary_id

2016-102

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00106942

Identifier Type: -

Identifier Source: org_study_id