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Completed

NCT Number: NCT04963114

Art Therapy Program in the Chronic Phase of Stroke

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.

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Key information

Age range

65 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University

Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Art Therapy

Behavioral

guided art tour and workshop

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. Change in mood assessed with the Beck Depression Abbreviated Inventory

    Time frame: 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

    Time frame: 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

    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.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 15, 2021
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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