- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04963114
Art Therapy Program in the Chronic Phase of Stroke
Art Therapy Program in the Chronic Phase of Stroke: A Feasibility Pilot Study
INTRODUCTION: After stroke, perceptual impairments, such as negative body perception, contribute to social isolation and depression. In the subacute poststroke phase, art therapy is effective in improving depression, self-esteem, and community integration. Yet, no study has explored the effectiveness of art therapy at the chronic stage of a stroke; where motor recovery is slowed, and body image and self-esteem are deeply challenged.
OBJECTIVES: Primary; to assess the feasibility of an art therapy program (ATP) in the chronic phase of stroke. Secondary; to explore the effects of ATP on perceptual impairment (body image/self-esteem), mood and community integration.
METHOD: Nine adults (stroke ≥6 months) will participate in the ATP consisting of a thematic group visit to the Montreal Museum of Fine Arts followed by an art workshop, supervised by an art therapist (7 visits over 4 months). Feasibility will be evaluated by triangulating data from interviews and subject assessment questionnaires and by assessing retention and attendance. The effects of the ATP will be assessed by changes in perceptual and mood impairment questionnaires (Body Image States, Self-Esteem scales, Beck Depression Inventory-Short-Form) and community integration questionnaire (The Community Integration Questionnaire).
EXPECTED RESULTS AND OUTCOMES: The project will confirm the feasibility of ATP to improve perceptual impairment and community integration post-stroke.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Quebec
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Montréal, Quebec, Canada
- McGill University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- be in the chronic stroke phase (≥ 6 months since diagnosis)
- present a low score on the self-esteem scale (score < 32/40 on the French-Canadian Self Esteem Scale)
- present mild to moderate degree of depression (score 4 to 15 in the Beck Depression Abbreviated Inventory)
Exclusion Criteria:
- unable to move autonomously and safely on their own
- present aphasia (score < 28/35 in the communication section of the Stroke Impact Scale)
- present severe hemineglect (score > 70% in the Line Cancelation Test)
- present severe spasticity of the hemi-body (score ≥ 3 on the modified Ashworth scale)
- present cognitive impairment (score ≤ 2/5 in the Mini-Cog)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Art therapy
art therapy in the form of a one-hour guided tour of art works followed by a two-hour guided creative painting workshop on specific themes such as beauty and wonder and colors and emotions
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guided art tour and workshop
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retention rate to the art therapy program
Time Frame: within 7 days after completion of the art therapy program
|
the number of participants enrolled at the end of the study divided by the number of participants recruited at the beginning of the study
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within 7 days after completion of the art therapy program
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Adherence to the art therapy program
Time Frame: within 7 days after completion of the art therapy program
|
the number of art therapy sessions that participants took part in on a total of 7 visits
|
within 7 days after completion of the art therapy program
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Participants' acceptability and perceptions of the effects of the art therapy program
Time Frame: within 7 days after completion of the art therapy program
|
Individualized semi-structured 50-minute interviews and a 2-hour focus group interview, conducted by a research assistant, gathered information on the participants acceptability of the art therapy program and its effects on their perceptual problems, mood and level of activity
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within 7 days after completion of the art therapy program
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self esteem assessed with the Rosenberg Self-Esteem Scale
Time Frame: baseline and within 7 days after completion of the art therapy program
|
The Rosenberg Self-Esteem Scale: The scale comprises 10 items scored on a 4-point Likert scale ranging from strongly agree to strongly disagree.
Scoring ranges from zero to 40, with higher scores indicating higher self-esteem
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baseline and within 7 days after completion of the art therapy program
|
Change in mood assessed with the Beck Depression Abbreviated Inventory
Time Frame: baseline and within 7 days after completion of the art therapy program
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Beck Depression Abbreviated Inventory : The scale comprises 13 items scored on a 4-point continuum scale (0 = least, 3 = most), with a total summed score ranging from 0 to 39. Higher scores correspond to greater depressive severity
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baseline and within 7 days after completion of the art therapy program
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Change in body image assessed with the Body Image States Scale
Time Frame: baseline and within 7 days after completion of the art therapy program
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Body Image States Scale: This 6-item questionnaire assesses, among other things, the persons dissatisfaction or satisfaction (from extremely dissatisfied with to extremely satisfied with) their physical appearance, body size, body shape and weight.
The measure is the composite mean of the six 9-point items whereas low scores reflect more negative body image states and high scores reflect more positive states
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baseline and within 7 days after completion of the art therapy program
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Change in community integration assessed with the Community Integration Questionnaire
Time Frame: baseline and within 7 days after completion of the art therapy program
|
Community Integration Questionnaire: It is a 15-item questionnaire that aims to identify participants' level of integration into home, family life, social activity, and productive activity.
The overall score, which represents a summation of the scores from individual questions, ranges from 0 to 29 whereas a higher score indicates greater integration, and a lower score reflects less integration.
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baseline and within 7 days after completion of the art therapy program
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP-31-2019-3003 - ART
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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