NCT04963114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

1.3 years

First QC Date

June 16, 2021

Last Update Submit

July 5, 2021

Conditions

Keywords

art therapyperceptual impairmentdepression

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

  • Change in self esteem assessed with the Rosenberg Self-Esteem Scale

    baseline and within 7 days after completion of the art therapy program

  • Change in mood assessed with the Beck Depression Abbreviated Inventory

    baseline and within 7 days after completion of the art therapy program

  • Change in body image assessed with the Body Image States Scale

    baseline and within 7 days after completion of the art therapy program

  • Change in community integration assessed with the Community Integration Questionnaire

    baseline and within 7 days after completion of the art therapy program

Study Arms (1)

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

Behavioral: art therapy

Interventions

art therapyBEHAVIORAL

guided art tour and workshop

Art therapy

Eligibility Criteria

Age65 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

StrokeDepression

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher and principal investigator

Study Record Dates

First Submitted

June 16, 2021

First Posted

July 15, 2021

Study Start

August 9, 2018

Primary Completion

December 6, 2019

Study Completion

December 6, 2019

Last Updated

July 15, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations