The Psycho-physiological & Social-spiritual Effects of Expressive Arts-based Intervention on Young and Pre-elderly Stroke Survivors: A Randomized Controlled Study
Phase: NA
Conditions: Stroke
Sponsor: The University of Hong Kong

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Study Protocol and Statistical Analysis Plan  
 
 
Unique Protocol ID: 17609417 
 
Brief Title: Expressive Arts-based Intervention on Young and Pre-elderly Stroke Survivors 
 
Official Title: The Psycho-physiological & Social-spiritual Effects of Expressive Arts-based 
Intervention on Young and Pre-elderly Stroke Survivors: A Randomized Controlled Study 
 
Document Creation Date: April 13, 2023 
 
Version: 3 
 
 
 

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Overview of the research study 
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 [1]. 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 [2], as well as the resulting deterioration of occupational functioning [3]. 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, isolation, 
and impaired quality of life. Though the risk of stroke increases with age [4], statistics have 
documented an increasing trend of a younger age of onset [5, 6]. The issues faced by young and pre-
elderly stroke survivors (<65 years old) will be even more severe due to longer term of survival, 
problems in resuming their occupations, and a lack of social welfare and resources for their pre-elderly 
age. 
 
With an increasing survival rate following stroke and a younger age of onset, reducing morbidity 
and achieving better quality of life after stroke become a pressing aim during survivorship [7]. Along 
with regaining the ability to perform daily activities satisfactorily, literature highlights the importance 
of reestablishing connection with others and the ability to affirm life through a relationship with the 
deity, self, community, and environment that nurtures wholeness [8, 9]. Although ischemic stroke and 
hemorrhagic stroke differ in terms of risk factors, case fatality, recurrence rates, and treatment options, 
survivors of both types of stroke share common psychosocial consequences and similar coping 
trajectories [10-12]. Residual psychosocial-spiritual post-stroke consequence has been found to be 
decisive in survivors’ compliance to rehabilitation and recovery outcomes [8]. To help younger stroke 
survivors cope with the bio-psychosocial-spiritual concerns, there is a need for holistic rehabilitation 
program, in particular, non-pharmacological, as adjuvant to conventional occupational rehabilitation 
regimens to buffer against mental health issues, reduce psychosocial stress, resume social connections, 
and reinstall hope [7, 13].  
 
Understanding the application of expressive arts in stroke rehabilitation 
Evidence supporting the effectiveness of arts-based activities, such as drawing, music, dance, drama, 
and movement, in stroke rehabilitation has been proliferating over the past five years [14-17]. Out 
team has several completed and ongoing research projects using expressive arts-based intervention for 
diverse populations [18, 19]. Positive outcomes have been observed and intervention has been widely 
welcomed. Although studies on the effectiveness of interventions using single or two arts modalities 
(i.e. art, dance, movement, and music therapy) have shown promising results [19, 20], evidence for 
multi-model expressive arts-based intervention, bringing together the strengths of different art 
modalities is relatively limited locally and internationally. Expressive Arts-based Intervention utilizes 
all arts modalities such as visual art, music, movement, dance, drama, and writing [21]. It focuses not 

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on the artistic outcomes but on the process of creating and the capacity of arts to reflect and respond 
to human sufferings. Such variety of art forms multiples the avenues by which a person in therapy may 
seek meaning, clarity, insight, and healing [21, 22]. Creating arts contributes to feelings of autonomy 
and dignity when other aspects of life seem out of control [23]. Through the creative self-expression, 
the person may uncover strengths, gain insight, and reclaim aspects of self-identity and worthiness of 
life [24].  
 
 

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Background of the study 
 
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 normal daily living. The issues faced by young (<45 years old) [4] and pre-elderly 
stroke survivors (46-65 years old) [11] will be even more severe due to longer term of survival and 
possible problems in resuming their functioning for independent living. And this group of people will 
not be eligible for medical care services, social welfare and resources which are specifically designated 
to the elderly population (>65 years old). In Hong Kong, stroke is the fourth most common cause of 
mortality (accounting for 7.5% of all registered deaths) [25]. The illness is considered one of the health 
conditions with the highest burden of disease worldwide; about 60% of all strokes results in disability, 
physical dependency and impairments [5]. Despite a decreasing trend in annual stroke mortality rates, 
stroke remains a significant health concern in Hong Kong. The prevalence rate of stroke increased 
from 2.8% in 1988 to 4.9% in 2008, and will continue to increase following the global aging trend [4]. 
Local statistics showed an alarmingly younger age of onset (<65 years old) [4]; during 1999-2007, the 
incidence of stroke and its related risks have increased in the young age cohort (25-44 years) [5]. 
Although ischemic and hemorrhagic stroke have different etiology and treatment options, [26]; coping 
trajectories for survivors of both types of stroke might be similar in some ways [12]. All stroke 
survivors experience common irreversible psychosocial consequences among the survivors [3, 12]. In 
Hong Kong, post-stroke depression occurs in 17.2% of stroke survivors, and quality of life is reported 
to deteriorate steadily over the 12-month period post-stroke in spite of recovery in physical function 
[4], which results in increased dependency, life dissatisfaction, reduced confidence [7, 27], social 
isolation, and compromised quality of life 2 years following initial stroke onset [28]. 
 
Stroke rehabilitation and psychophysiological stress 
  Management of psychosocial stress is an important aspect in post-stroke management. Prolonged 
psychosocial stress is an established risk factor of mortality and stroke-related complications [13]. 
Depression and psychosocial stress are risk factors for stroke; while stroke is known to be a strong risk 
factor for depression and stress [29]. Cortisol is a stress biomarker and an objective measure of 
psychological stress that reflects the hypothalamic-pituitary-adrenal (HPA) axis functioning. A 
previous study has showed that elevated cortisol is correlated with increased stroke severity; and such 
distortion in diurnal cortisol profile is linked with longer hospital stay for inpatients, higher dependency, 
greater risk of depression and delirium for outpatient stroke survivors [30]. Given the important 
implication of psychological distress and cortisol on stroke severity and rehabilitation outcome, it is 
important to examine the changes in psychological distress as well as cortisol profiles during the 
rehabilitation period. 
 
The need for a holistic, arts-based approach to stroke rehabilitation 

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  With the increasing post-stroke survival rates and a younger age of onset, reduction of morbidity 
and achieving a better quality of life after stroke becomes a more pressing aim during survivorship [7]. 
Along with regaining the ability to perform daily activities properly, literature highlights the 
importance of reestablishing connection with others and the ability to affirm life though a rehabilitation 
with the deity, self, community, and environment that nurtures wholeness, which in turn improves 
compliance to rehabilitation and recovery outcomes [31]. 
 
  Aligning with these needs, interdisciplinary rehabilitation programs addressing the psychosocial-
spiritual dimensions of needs of stroke survivors have been accumulating in the field [2, 14, 41]. 
Among them, Arts-based interventions have drawn increasing attention due to its non-pharmacological, 
strength-based, positive orientation with an enjoyable and safe process in stroke rehabilitation [23]. 
Therapeutic use of arts has been found to be effective in facilitating emotion expression and improving 
mood, mobility, social relationship and quality of life of stroke survivors [32]. As opposed to a single 
modality intervention, an Expressive Arts-based Intervention utilizes all arts modalities such as visual 
art, music, movement, dance, drama, and writing [21]. Such variety multiplies the avenues by which a 
person in therapy may seek meaning, clarity, insight and healing [21, 22]. Creating arts contributes to 
feelings of autonomy and dignity when other aspects of life seem out of control [23]. Through the 
creative self-expression, the person may uncover strengths, gain insight, and reclaim aspects of self-
identity and worthiness of life [24]. It also allows survivors to move away from illness-related 
preoccupations and derive greater satisfaction and self-esteem as they witness the quality of their 
artwork and gain positive feedback from others [34]. The non-verbal communication and symbolic 
expression through arts media during the process will further enhance engagement and help articulate 
feelings or thoughts that are difficult to be expressed through verbal means. The use of arts can be a 
joyful, engaging, and safe alternative to traditional therapies for management of stroke and its psycho-
social-spiritual comorbidities. 
 
Nevertheless, systematic study related to arts-based intervention has not yet been conducted, in 
particular for younger stroke survivors, who may face bigger and longer-term impacts in the 
psychophysiological and social-spiritual outcomes. The present study primarily examines the 
effectiveness of an Expressive Arts-based Intervention on bio-psychosocial-spiritual outcomes in 
younger Chinese stroke survivors as compared with the treatment-as-usual control group across 
different time points. It also aims to explore the associations between the psycho-social-spiritual 
variables and cortisol profiles as well as the changes of such association across time. Besides, this 
study also targets at understanding younger stroke survivors’ first person body perception and the 
body-mind mechanism among them. Moreover, participants’ nature of ischemic or hemorrhagic stroke 
will be accounted for using statistical methods to explore common and differential effects of 
Expressive Arts-based Intervention on both types of stroke. 
 

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Study Aims 
Primary objectives: 
To investigate the short and longer-term effects of an Expressive Arts-based Intervention on younger 
and pre-elderly Chinese stroke survivors on: 
(a) Depressive and anxiety symptoms 
(b) Perceived stress 
(c) Perceived social support 
(d) Self-esteem 
(e) Hope 
(f) Subjective and spiritual well-being 
(g) Stroke-related and general related quality of life 
(h) Salivary cortisol level 
Secondary objectives: 
(a) To examine the associations between cortisol levels, diurnal cortisol profiles and psycho-
social-spiritual variables in participants 
(b) To examine the changes of the associations between cortisol levels, diurnal cortisol profiles 
and psycho-social-spiritual variables across the time points.  
 
Study hypotheses 
1. Expressive Arts-based Intervention is more effective than treatment-as-usual control in  
(a) reducing depressive and anxiety symptoms 
(b) reducing stress 
(c) enhancing perceived social support 
(d) enhancing self-esteem 
(e) fostering hope 
(f) cultivating subjective and spiritual well-being 
(g) enhancing stroke-related and general quality of life 
2. Expressive Arts-based Intervention group will be different from control group in altering salivary 
cortisol levels and profiles 
3. The associations between cortisol profiles and psychosocial-spiritual variables and the changes of 
such associations across the time points are exploratory in this study.  
 
 
 

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Methodology 
Research design 
  The study will adopt a 2-arm randomized controlled design with treatment-as-usual control. 
Appendix A depicts the conceptual model of the study. 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. 
 
Sample size determination, participant eligibility and recruitment 
  To achieve a statistical power of 80% with a medium effect size (Cohen d = 0.63) at a significance 
level of 0.05 in regression modeling (latent growth modeling) under the proposed 2-arm, 3-time point 
design, a sample size of 116 is needed according to Monte Carlo simulation. Assuming an attrition rate 
of 25%, based on prior trials on stroke survivors using arts-based therapies [14], a total of 154 
participants are required (i.e. 77 per arm). Eligible participants are Chinese, aged 18 to 64, having an 
acute stroke episode no more than 120 months before by the time of group participation; both ischemic 
and hemorrhage stroke survivors will be recruited. Since stroke survivors who are under 65 years old 
are not qualified to receive any elderly services and welfare, there is a lack of resources and support 
for these individuals. The targeted age range of 18 to below 65 years old in the present study is 
specifically set for filling the service gap in local situation as well as for practical reason to ensure 
recruitment of sufficient participants for the study sample. 
 
Recruitment information will be delivered via posters, pamphlets, newsletters, and website of the 
Community Rehabilitation Network of the Hong Kong Society for Rehabilitation, Department of 
Social Work and Social Administration, Centre on Behavioral Health of the University of Hong Kong, 
and Department of Rehabilitation Sciences, The Hong Kong Polytechnic University. The recruitment 
process will also take part in Queen Mary Hospital and Tung Wah Hospital. Once the stroke cases 
discharged from the hospitals, responsible research assistant will contact and invite them to participate 
in this research study. Screening will be performed after recruitment by a trained research assistant 
based on the inclusion-exclusion criteria (Appendix B). 
 
Intervention group(s) 
The Expressive Arts-based Intervention group will consist of 8 weekly 90-minute sessions, with a 
total of 12 contact hours. The intervention will be delivered in small group format with 6-8 participants 
each and led by a registered Expressive Arts Therapist and an expressive arts therapy trainee/student 
helper. The program follows the structure of a typical arts-based intervention program which has been 

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applied to Chinese populations with various ages, abilities, and conditions [20]. The content of the 
program also takes reference from previous expressive arts-based intervention programs which have 
been used for adults with trauma, mental health issues, and chronic illness [20, 37, 43] to suit the needs 
of stroke survivors and the purposes of the intervention (Appendix C). The program includes gentle 
movement warm-up with the body parts, simple musical rhythm improvisation to encourage creativity 
and social interactions, arts-making process with themes of strength, stress coping, care and love, piece 
of joy, exploration of hope and meaning, and followed by sharing of arts-making experiences to 
enhance intrapersonal and interpersonal connections. To cater to different conditions of the participants, 
activities can be done in standing or sitting positions, or in a wheelchair. The structure and schedule of 
each session will be kept similar while the content can be appropriately adjusted to suit the immediate 
needs and dynamics of the group. The program has been tested with a group of stroke survivors and 
demonstrated to be feasible and well-received.  
 
The Treatment-As-Usual Control group will continue with routine healthcare and rehabilitation 
services. They would be given the option to participate in the Expressive Arts-based Intervention after 
the 8-month study period. 
 
Ethical consideration 
  The study is reviewed by the Human Research Ethics Committee (HREC) and the Institutional 
Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA 
HKW IRB). Written informed consent will be obtained from the participants before screening, 
assessment and randomization. To ensure confidentiality, participant codes will be assigned to 
represent the participants. All data collected will be stored in locked storage and destroyed 3 years 
upon study completion.  
 
Outcome measurements 
  Assessments pertain to areas of psycho-social-spiritual well-being of stroke survivors, including (a) 
emotional distress, (b) psychosocial functioning, (c) quality of life, (d) physiological biomarkers, and 
(e) demographics and clinical details. Self-related questionnaires and salivary cortisol are administered 
by the participants while blood pressure, heart rate, will be measured by a trained research assistant 
blinded to the randomization. All measurements are taken at all study time points except for 
demographics and clinical details. Since the impairment levels of stroke survivors vary and may affect 
rehabilitation progress and intervention outcomes, a disability assessment will be used as a screening 
tool to understand the physical condition of the participants and for recruitment of the participants into 
the trial.  
 
 
 

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Screening 
Disability. The Modified Rankin Scale is a clinician-reported rating scale for measuring the degree 
of disability of the stroke participants. The scale is rated on an ordinal scale of 0 to 6, with a higher 
score denoting higher level of disability post-stroke [47]. 
 
Outcome measures 
 
Emotional distress 
Depression and anxiety. The Chinese version of the Hospital Anxiety and Depression Scale [48] 
captures anxiety and depressive symptoms. The 14-item, 4-point scale measures anxiety (7-item) and 
depression (7-item) subscales. The measure will be used as an outcome measure on mental health 
distress. 
Perceived stress. Perceived stress will be assessed by the Chinese Perceived Stress Scale [49]. Using 
a 5-point Likert scale (0-4), the scale consists of 10 items about the degree to which life events are 
appraised as stressful. 
 
Psychosocial functioning 
Perceived social support. Perceived social support is captured by the Chinese version of the 
Multidimensional Scale of Perceived Social Support [50]. The 12-item scale composes of subscales 
for perceived social support from the family, friends, and significant others, rated on a 7-point Likert 
scale. 
  Self-Esteem. Self-esteem is documented by the Chinese version of the Rosenberg Self-esteem Scale 
[51]. The 10-item scale, rated on an 4-point scale, yields a total score of self-esteem.  
Hope. The Chinese version of the Adult State Hope Scale [52] is used to measure hope. The 6-item 
scale, rated on an 8-point scale, yields an aggregate score of hope, as well as the agency and pathway 
subscales. 
Spiritual well-being. Participants’ intention to find peace and to take care of their own spiritual needs 
will be measured by the 3-item spiritual care subscale of the Body-Mind-Spirit Holistic Well-being 
Scale, rated on an 11-point anchored scale. The scale measures different dimensions of subjective well-
being in the context of afflictions and equanimity [53]. 
 
Quality of life 
Stroke-specific quality of life. The Chinese version of the Stroke-specific Quality of Life (SS-QoL-
CH), Short Form is a 12-item disease-specific health-related quality of life measure widely applied in 
stroke research. The scale yields 2 QoL subscales in physical and psychosocial components rated on a 
5-point scale. 
Health-related quality of life. The Chinese 12-item Short Form (SF-12) Health Survey [54] is used 
to measure the health-related quality of life on the dimensions of physical and emotional well-being. 

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Psychophysiological biomarkers 
Salivary Cortisol. Saliva samples will be collected by the participants at five prescribed time points 
(awakening, 45-minute post-awakening, 12 noon, 5pm, and 9pm) on two consecutive days using the 
collection device package, Salivette, which includes a cotton swab to place under the tongue. A trained 
research assistant with prior experience in using the Salivette kit will explain the collection procedures 
to the participants in details. A record sheet will also be included in the package to document the 
participants’ health behaviors and activities on the day of saliva collection that might affect the diurnal 
cortisol rhythm, including (a) smoking habit, (b) consumption of alcohol/coffee drinking on that day, 
and (c) subjective evaluation of sleep quality, total sleep duration, stress levels on a scale of 1 to 10. 
All of these measures may affect the diurnal cortisol rhythm and will be controlled in the analysis. 
 
Demographics and clinical details 
Demographics. Socio-demographic, such as age, gender, education level, employment and 
financial status, and marital status will be documented based on self-report questionnaires. 
Clinical data. Participants’ clinical profile including the type of stroke, time lapse from first 
occurrence, onset and history of psychiatric disturbance, presence of comorbidity if any (such as 
physical disabilities, hypertension, diabetes mellitus, or any other form of vascular disease), treatment 
and medication record, and psychosocial support and/ or rehabilitation service utilization will be 
documented. 
 
Data analyses 
Effectiveness of Expressive Arts-based Intervention group: Analysis of variance and chi-square 
independence tests will be carried out using SPSS to compare the demographic profile of the two 
groups. Latent growth modeling in Mplus will be used to explore the effectiveness of the intervention 
over the assessment points in comparison with the control group. All variables including the 
demographic variables (e.g. age, gender, education etc.) will be accounted for in the analysis. 
 
Analysis of Salivary Cortisol Data: Saliva sample will be centrifuged at 3,000 rpm for 10 minutes 
at room temperature. Cortisol level will be determined with an enzyme-linked immunoabsortbent assay 
kit (EIA, Salimetrics, Inc). The assay sensitivity is 0.193 nmol/l and the intra-assay and inter-assay 
coefficients of variation are 3% and 10% respectively. The mean cortisol level across the day, total 
cortisol level indexed by the area under the curve, and the diurnal cortisol slope will be calculated. To 
explore individual trajectories of changes in cortisol level over time and the complex relationships 
between different variables, a two-level individual growth curve model using Mplus software will be 
adopted since cortisol measures at 5 daily time points are nested within participants. The method is an 
appropriate variant of multiple regression modeling for the nested structure of cortisol data. 
 
 

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APPENDIX A: A Conceptual Model of the Proposed Study  
 
 
 
 
 

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APPENDIX B: Inclusion-Exclusion Criteria  
 
 
 

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APPENDIX C: Session content of Expressive Arts-based Intervention 
 
 
 

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