NCT06725251

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2022

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

5.9 years

First QC Date

December 5, 2024

Last Update Submit

December 5, 2024

Conditions

Keywords

self esteemcaregiverart therapy

Outcome Measures

Primary Outcomes (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).

    Week 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).

    Week 4

Secondary Outcomes (6)

  • Impact of Art Therapy on Dementia Individuals' Self-esteem

    Week 1

  • Impact of Art Therapy on Dementia Individuals' Self-esteem

    Week 4

  • Impact of Art Therapy on Dementia Individuals' Sense of Stigma

    Week 1

  • 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 1

  • +1 more secondary outcomes

Study Arms (1)

Dementia Participants and Care Partners

EXPERIMENTAL

Dyads including a participant diagnosed with dementia and the care partner

Behavioral: Art Therapy

Interventions

Art TherapyBEHAVIORAL

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.

Dementia Participants and Care Partners

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advocate Memory Center

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Conditions

Dementia

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Darren Gitelman, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 10, 2024

Study Start

August 26, 2016

Primary Completion

August 2, 2022

Study Completion

August 2, 2022

Last Updated

December 10, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations