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Expressive Arts-based Intervention for Young and Pre-elderly Stroke Survivors

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ClinicalTrials.gov Identifier: NCT03729648
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Brief Summary:
Stroke is a devastating illness that induces numerous impairments of body function and structure, and limitations to activities in all aspects of life, thus imposing multi-faceted restrictions on one's participation in daily living. It also has detrimental impacts on one's mental health, social relationship, and quality of life. Existing research focuses primarily on older adults stroke survivors; this study is set out to contribute to current knowledge of the effectiveness of arts-based rehabilitation on younger stroke survivors. Both psychological and physiological outcomes will be examined for a comprehensive understanding on the biological, psychological, social, and spiritual changes after participating in a non-pharmacological, engaging, safe and enjoyable multi-modal expressive arts-based intervention approach of rehabilitation.This current study will adopt a 2-arm randomized controlled design with treatment-as-usual control. Upon screening for inclusion exclusion criteria, baseline data will be collected; and eligible participants will be randomized into either an 8-week Expressive Arts-based intervention group or Treatment-As-Usual control group.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Expressive Arts Therapy Not Applicable

Detailed Description:

Stroke is a devastating illness that induces numerous impairments of body function and structure, and limitations to activities in all aspects of life, thus imposing multi-faceted restrictions on one's participation in daily living. It also has detrimental impacts on one's mental health, social relationship, and quality of life. Stroke survivors often face challenges arising from the illness and its disabilities, as well as the resulting deterioration of occupational functioning. They also suffer from the psycho-spiritual sequels of loss in functioning, sense of worthlessness and hopelessness, and fear of relapse, all of which could result in mental health distress such as depression, anxiety, stress, isolation, and impaired quality of life. Though the risk of stroke increases with age, statistics have documented an increasing trend of a younger age of onset. The issues faced by younger and pre-elderly stroke survivors (<65 years old) will be even more severe due to longer term of survival, problems of resuming their occupations, and lacking of social welfare and resources for their pre-elderly age.

Existing research focuses primarily on older adults stroke survivors; this study is set out to contribute to current knowledge of the effectiveness of arts-based rehabilitation on younger stroke survivors. Both psychological and physiological outcomes will be examined for a comprehensive understanding on the biological, psychological, social, and spiritual changes after participating in a non-pharmacological, engaging, safe and enjoyable multi-modal expressive arts-based intervention approach of rehabilitation.

Examination on the relationships among bio-psycho-social-spiritual variables may help understand the complex relationships among these factors after stroke and during rehabilitation, which will contribute to the development of holistic care for stroke survivors.

This current study will adopt a 2-arm randomized controlled design with treatment-as-usual control. Upon screening for inclusion exclusion criteria, baseline data will be collected; and eligible participants will be randomized into either an 8-week Expressive Arts-based intervention group or Treatment-As-Usual control group. The control group will continue with routine rehabilitation service and have the option to participate in the Expressive Arts-based Intervention Group upon study completion. Participants will be assessed 3 times at baseline (T0), post-intervention (8th week, T1), and 6-month post-intervention (T2). The participants will complete the study in about 8 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Randomized Controlled Trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Psycho-physiological & Social-spiritual Effects of Expressive Arts-based Intervention on Young and Pre-elderly Stroke Survivors: A Randomized Controlled Study
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Intervention
This arm of participants will be receiving Expressive Arts Therapy as intervention
Behavioral: Expressive Arts Therapy
The intervention brings together the strengths of different art modalities, such as visual art, music, movement, dance, drama and writing to assist reflect and response in individuals to their personal issues. Such variety of art forms multiplies the avenues by which a person in therapy may seek meaning, clarity, insight and healing.

No Intervention: Control
This arm of participants will not receive any intervention and are allocated as a wait-list control group



Primary Outcome Measures :
  1. Change from Baseline Depression and Anxiety level at 2 months and 8 months [ Time Frame: Baseline, Month 2, and Month 8 ]

    Administration of the Chinese translated version of Hospital Anxiety and Depression Scale

    • This scale is adopted to measure the level of Depression and Anxiety.
    • Two scores, Depression score and Anxiety score, are generated.
    • The minimum score is 0 and the maximum score is 21.
    • Scores ranging from "0-7" represents "Normal", ranging from "8-10" represents "Borderline abnormal", and ranging from "11-21" represents "Abnormal".

  2. Change of Baseline Perceived Stress level at 2 months and 8 months [ Time Frame: Baseline, Month 2, and Month 8 ]

    Administration of Chinese translated version of Perceived Stress Scale

    • This scale is adopted to measure the level of perceived stress
    • The total score of Perceived Stress Scale is summing all the scores from each item, with Q4, Q5, Q7, and Q8 are reverse items.
    • The minimum score is 0 and the maximum score is 40.
    • Scores ranging from "0-13" represents low stress, ranging from "14-26" represents moderate stress, and "27-40" represents high perceived stress.

  3. Change of Baseline Perceived Social Support level at 2 months and 8 months [ Time Frame: Baseline, Month 2, and Month 8 ]

    Administration of the Chinese version of the Multidimensional Scale of Perceived Social Support

    • This scale has adopted the measure the level of perceived social support from family, friends, or significant other.
    • The mean score of perceived social support from "family" is calculated by summing across Q3, Q4, Q8, and Q11, then divide by 4.
    • The mean score of perceived social support from "friends" is calculated by summing across Q6, Q7, Q9, and Q12, then divide by 4.
    • The mean score of perceived social support from "significant other" is calculated by summing across Q1, Q2, Q5, and Q10, then divide by 4.
    • The mean total score is calculated by summing across all 12 items, then divide by 12.
    • The minimum mean score of each sub-score and the total score is 1 and the maximum mean score is 7.

  4. Change of Baseline Hope level at 2 months and 8 months [ Time Frame: Baseline, Month 2, and Month 8 ]

    Administration of the Chinese version of the Adult State Hope Scale

    • This scale is adopted to measure the level of hope.
    • Pathways sub-scale score is calculated by summing across Q1, Q3, and Q5.
    • Agency sub-scale score is calculated by summing across Q2, Q4, and Q6.
    • Total hope score is calculated by summing all items.
    • The minimum score of the sub-scales is 3 and the maximum score of the sub-scales is 24.
    • The minimum score of the total score is 6 and the maximum score of the total score is 48.
    • The higher the scores in sub-scales represents higher levels of pathways thinking or higher agency thinking respectively. The higher total score represents higher hope levels.

  5. Change of Baseline Spiritual well-being level at 2 months and 8 months [ Time Frame: Baseline, Month 2, and Month 8 ]

    Administration of the Chinese version of 3-item spiritual care sub-scale of the Body-Mind-Spirit Holistic Well-being Scale

    • This sub-scale is adopted to measure the level of spiritual well-being.
    • The sub-scale score is calculated by summing across all the three items.
    • The minimum score of this sub-scale is 3 and the maximum score of this sub-scale is 30.
    • The higher the score represents higher level of spiritual well-being.

  6. Change of Baseline Stroke-specific quality of life at 2 months and 8 months [ Time Frame: Baseline, Month 2, and Month 8 ]

    Administration of the Chinese version of the Stroke-specific Quality of Life Short Form

    • This scale is adopted to measure the level of stroke-specific Quality of Life.
    • The score is calculated by summing across all the twelve items.
    • The minimum score of this scale is 12 and the maximum score of this scale is 60.
    • The higher the score represents higher level of stroke-specific quality of life.

  7. Change of Baseline general quality of life at 2 months and 8 months [ Time Frame: Baseline, Month 2, and Month 8 ]

    Administration of the Chinese version of the 12-item Short Form Health Survey

    • This scale is adopted to measure the level of health-related Quality of life.
    • Q1, Q8, Q9, and Q10 are reversed items.
    • Physical and Mental Health Composite Scale scores are calculated.

  8. Change of Baseline Physical stress level and cortisol rhythm at 2 months and 8 months [ Time Frame: Baseline, Month 2, and Month 8 ]
    Collection of saliva samples for analysis

  9. Change of Baseline Blood Pressure at 2 months and 8 months [ Time Frame: Baseline, Month 2, and Month 8 ]
    Measuring both systolic and diastolic blood pressure

  10. Change of Baseline Heart Rate at 2 months and 8 months [ Time Frame: Baseline, Month 2, and Month 8 ]
    Measuring heart rate (beats per minute)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of a single-lesion stroke in the left or right, temporal, frontal, parietal or subcortical brain region
  • Being in the early-phase of stroke (i.e. not more than 12 months after an initial stroke) at the time of group participation
  • Diagnosis of either (a) ischemic or (b) hemorrhage stroke
  • Disability grade 2 to 4 on Modified Rankin Scale
  • Residual function of the affected extremity (i.e. the ability to move the affected arm and the index finger without help from the healthy side)
  • The ability to understand instructions, both verbal and written in Chinese
  • Ages between 18 to 64*

(*considering that participants need 8 more months to complete the study)

Exclusion Criteria:

  • Prior to concurrent diagnosis of major medical or psychiatric disorders other than stroke
  • Currently receiving hospital treatment and care
  • Presence of hearing or visual deficits, even with aids
  • Total paralysis of the upper limbs
  • Amputation of one of the limbs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729648


Contacts
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Contact: Rainbow Ho (852)28315181 tinho@hku.hk

Locations
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Hong Kong
Centre on Behavioral Health HKU Recruiting
Hong Kong, Hong Kong
Contact: Temmy Lo    (852)28315161    temllt@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Rainbow Ho Director/Professor
  Study Documents (Full-Text)

Documents provided by The University of Hong Kong:

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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03729648     History of Changes
Other Study ID Numbers: 17609417
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The University of Hong Kong:
Younger Stroke survivors
Expressive Arts Therapy
Rehabilitation
Randomized Controlled Trial
Salivary Cortisol

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases