Art Therapy Program in the Chronic Phase of Stroke

Sponsor
Université de Sherbrooke (Other)
Overall Status
Completed
CT.gov ID
NCT04963114
Collaborator
McGill University (Other), Laval University (Other), Concordia University, Montreal (Other), Université de Montréal (Other)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: art therapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Art Therapy Program in the Chronic Phase of Stroke: A Feasibility Pilot Study
Actual Study Start Date :
Aug 9, 2018
Actual Primary Completion Date :
Dec 6, 2019
Actual Study Completion Date :
Dec 6, 2019

Arms and Interventions

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

Behavioral: art therapy
guided art tour and workshop

Outcome Measures

Primary Outcome Measures

  1. Retention rate to the art therapy program [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

  2. Adherence to the art therapy program [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

  3. Participants' acceptability and perceptions of the effects of the art therapy program [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

Secondary Outcome Measures

  1. Change in self esteem assessed with the Rosenberg Self-Esteem Scale [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

  2. Change in mood assessed with the Beck Depression Abbreviated Inventory [baseline and within 7 days after completion of the art therapy program]

    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

  3. Change in body image assessed with the Body Image States Scale [baseline and within 7 days after completion of the art therapy program]

    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

  4. Change in community integration assessed with the Community Integration Questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 McGill University Montréal Quebec Canada

Sponsors and Collaborators

  • Université de Sherbrooke
  • McGill University
  • Laval University
  • Concordia University, Montreal
  • Université de Montréal

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marie-Hélène Milot, researcher and principal investigator, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT04963114
Other Study ID Numbers:
  • MP-31-2019-3003 - ART
First Posted:
Jul 15, 2021
Last Update Posted:
Jul 15, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marie-Hélène Milot, researcher and principal investigator, Université de Sherbrooke
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 15, 2021