Art Therapy Program in the Chronic Phase of Stroke

Stroke Clinical Trial

Official title:

Art Therapy Program in the Chronic Phase of Stroke: A Feasibility Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04963114
• Other study ID #: MP-31-2019-3003 - ART
• Status: Completed
• Phase: N/A
• Start date: August 9, 2018
• Est. completion date: December 6, 2019

Study information

• Verified date: July 2021
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 6, 2019
• Est. primary completion date: December 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• art therapy
guided art tour and workshop

Locations

Country	Name	City	State
Canada	McGill University	Montréal	Quebec

Sponsors (5)

Lead Sponsor	Collaborator
Université de Sherbrooke	Concordia University, Montreal, Laval University, McGill University, Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	within 7 days after completion of the art therapy program
Primary	Adherence to 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
Primary	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	within 7 days after completion of the art therapy program
Secondary	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	baseline and within 7 days after completion of the art therapy program
Secondary	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	baseline and within 7 days after completion of the art therapy program
Secondary	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	baseline and within 7 days after completion of the art therapy program
Secondary	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.	baseline and within 7 days after completion of the art therapy program