StrokeNCT04963114
Art Therapy Program in the Chronic Phase of Stroke
A study testing art therapy in people with Stroke, run by Université de Sherbrooke at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 65 to 79 years
- Conditions the study is for
- Stroke
- What is being tested?
- art therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 9 Aug 2018to 6 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 79 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Stroke
- Being tested
- art therapy
- Keywords
- art therapy, perceptual impairment, depression
- Medical subject headings
- Stroke, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
art therapyBehavioural
guided art tour and workshop
| Study group | Role | What they receive |
|---|---|---|
| Art therapy | Experimental | 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 Receives: Behavioral: art therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 7 days after completion of the art therapy program
Adherence to the art therapy program
the number of art therapy sessions that participants took part in on a total of 7 visits
Measured: within 7 days after completion of the art therapy program
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
Measured: within 7 days after completion of the art therapy program
Secondary outcomes (4)
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
Measured: baseline and within 7 days after completion of the art therapy program
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
Measured: baseline and within 7 days after completion of the art therapy program
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
Measured: baseline and within 7 days after completion of the art therapy program
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.
Measured: baseline and within 7 days after completion of the art therapy program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start9 Aug 2018
- Primary completion6 Dec 2019
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, Laval University, Concordia University, Montreal, Université de Montréal
- Responsible party
- Principal investigator, Marie-Hélène Milot, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963114
- Sponsor's protocol ID
- MP-31-2019-3003 - ART
- Status last verified
- Jul 2021
- First submitted
- 16 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Art Therapy Program in the Chronic Phase of Stroke: A Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT04963114
- Acronym / sponsor ID
- MP-31-2019-3003 - ART
- Conditions
- Stroke
- Keywords
- art therapy, perceptual impairment, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- McGill University, Laval University, Concordia University, Montreal, Université de Montréal
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Art therapy | Experimental | Behavioral: art therapyart 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 |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| art therapyguided art tour and workshop | Behavioural | Art therapy |
Primary outcome
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
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
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
4 secondary outcomes
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
Change in mood assessed with the Beck Depression Abbreviated Inventory
Time frame: baseline and within 7 days after completion of the art therapy program
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
Change in community integration assessed with the Community Integration Questionnaire
Time frame: baseline and within 7 days after completion of the art therapy program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: No
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Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing art therapy in people with Stroke, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate to the art therapy program (time frame: within 7 days after completion of the art therapy program). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.