Art Therapy Program in the Chronic Phase of Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
art therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring art therapy, perceptual impairment, depression
Eligibility Criteria
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)
Sites / Locations
- McGill University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Art therapy
Arm Description
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
Outcomes
Primary Outcome Measures
Retention rate to 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
Adherence to the art therapy program
the number of art therapy sessions that participants took part in on a total of 7 visits
Participants' acceptability and perceptions of the effects 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
Secondary Outcome Measures
Change in self esteem assessed with the Rosenberg Self-Esteem Scale
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
Change in mood assessed with the Beck Depression Abbreviated Inventory
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
Change in body image assessed with the Body Image States Scale
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
Change in community integration assessed with the Community Integration Questionnaire
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.
Full Information
NCT ID
NCT04963114
First Posted
June 16, 2021
Last Updated
July 5, 2021
Sponsor
Université de Sherbrooke
Collaborators
McGill University, Laval University, Concordia University, Montreal, Université de Montréal
1. Study Identification
Unique Protocol Identification Number
NCT04963114
Brief Title
Art Therapy Program in the Chronic Phase of Stroke
Official Title
Art Therapy Program in the Chronic Phase of Stroke: A Feasibility Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 9, 2018 (Actual)
Primary Completion Date
December 6, 2019 (Actual)
Study Completion Date
December 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
Collaborators
McGill University, Laval University, Concordia University, Montreal, Université de Montréal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
art therapy, perceptual impairment, depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Art therapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
art therapy
Intervention Description
guided art tour and workshop
Primary Outcome Measure Information:
Title
Retention rate to the art therapy program
Description
the number of participants enrolled at the end of the study divided by the number of participants recruited at the beginning of the study
Time Frame
within 7 days after completion of the art therapy program
Title
Adherence to the art therapy program
Description
the number of art therapy sessions that participants took part in on a total of 7 visits
Time Frame
within 7 days after completion of the art therapy program
Title
Participants' acceptability and perceptions of the effects of the art therapy program
Description
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
Time Frame
within 7 days after completion of the art therapy program
Secondary Outcome Measure Information:
Title
Change in self esteem assessed with the Rosenberg Self-Esteem Scale
Description
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
Time Frame
baseline and within 7 days after completion of the art therapy program
Title
Change in mood assessed with the Beck Depression Abbreviated Inventory
Description
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
Time Frame
baseline and within 7 days after completion of the art therapy program
Title
Change in body image assessed with the Body Image States Scale
Description
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
Time Frame
baseline and within 7 days after completion of the art therapy program
Title
Change in community integration assessed with the Community Integration Questionnaire
Description
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.
Time Frame
baseline and within 7 days after completion of the art therapy program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
McGill University
City
Montréal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Art Therapy Program in the Chronic Phase of Stroke
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