Investigation of the Effect of Acceptance and Commitment Therapy and Exercise in Older Adults With Chronic Pain: A Randomized Controlled Trial
Phase: NA
Conditions: Chronic Pain, Older Adults, Acceptance and Commitment Therapy, Exercise, Psychosocial Intervention, Art
Sponsor: The University of Hong Kong

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Investigation of the Effect of Acceptance and Commitment Therapy and Exercise in 
Older Adults with Chronic Pain: A Randomized Controlled Trial 
 
IDENTIFIERS: NCT05528536 
UNIQUE PROTOCOL ID: EA200132 
 
PROTOCOL DATE: February 7th, 2022 
 
INVESTIGATORS 
Terry YS Lum (Principal Investigator) 
Department of Social Work and Social Administration, HKU 
Gloria HY Wong (Co-Principal Investigator) 
Department of Social Work and Social Administration, HKU 
Dr. Tianyin Liu 
Department of Social Work and Social Administration, HKU 
Dr. Dara KY Leung 
Department of Social Work and Social Administration, HKU 
Ms. Wai Wai Kwok 
Department of Social Work and Social Administration, HKU 
Ms. Angie Shum 
Department of Social Work and Social Administration, HKU 
Ms. Annabelle PC Fong 
Department of Social Work and Social Administration, HKU 
 
PARTNERING ORGANIZATIONS 
The Hong Kong Jockey Club Charities Trust 
Aberdeen Kai-fong Welfare Association 
Caritas Medical Centre, Hong Kong 
Hong Kong Sheng Kung Hui Welfare Council Limited 
Hong Kong Young Women’s Christian Association 
The Neighbourhood Advice-Action Council 

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BACKGROUND 
Chronic pain is one of the common problems in older adults, affecting their physical 
ability, treatment satisfaction, quality of life and psychosocial functioning. Various 
types of exercises have shown to have a positive impact on physical well-being, but 
more improvements on pain outcomes is observed with psychological interventions. 
Among the different behavioural therapies, Acceptance and Commitment Therapy 
(ACT) holds the key behaviours in the adaption and prolonged effect in chronic pain. 
Previous study has shown benefits of combining ACT and Exercise, but the 
effectiveness is yet unknown. We aim to examine the effectiveness of this method with 
the intention of enhancing the overall well-being of older adults with chronic pain. 
 
OBJECTIVES 
The objective is to establish evidence of Acceptance and Commitment Therapy (ACT) 
in combination with exercise in: 
Primary Outcomes 
1) Reducing pain intensity and interference;  
2) Reducing depression; 
Secondary Outcomes 
3) Reducing anxiety; 
4) Increasing psychological flexibility; 
5) Increasing pain-related self-efficacy; 
6) Increasing quality of life; 
7) Increasing physical functioning 
 
METHODS 
Design 
This study adopts a cluster randomized trial design comparing older adults with chronic 
pain receiving ACT and exercise intervention to two arms: 1) art and exercise; and 2) 
treatment as usual (control group). 15-20 elderly from 10 different mental health service 
centres will be randomized to the experimental, sham, or active control group. 

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Participants 
The effect size from previous literature and pilot data (0.25), an alpha=0.05, 
and power=0.8 was used to derive the total sample size of 135 participants. Assuming 
10% attrition, total sample size = 150. Older adults with chronic pain (n=150) recruited 
from collaborating NGOs will be randomized into 3 different arms: 1) ACT and 
exercise; 2) art and exercise; and 3) treatment as usual. 
 
Inclusion criteria are: 
- age 60 years or above; and 
- have depressive symptoms of mild level or above (PHQ > 5) 
- have chronic pain (>3 months) 
- able to give informed consent to participate 
 
Exclusion Criteria: 
- known history of autism, intellectual disability, schizophrenia-spectrum disorder, 
bipolar disorder, Parkinson’s disease, or dementia 
- (temporary exclusion criteria) imminent suicidal risk difficulty in communication 
- have had stroke, fracture, cardiovascular disease, cardiovascular surgery, artery 
disease, surgery on vertebrae, and knee replacement in the past 6 months 
- physical activity prohibited by a medical professional 
 
Assessment Procedures 
After basic screening, assessments will be conducted by trained social services staff 
and trained research assistants employed by the University of Hong Kong for the 
intervention group. 
 
Assessments will be conducted for all 3 arms at baseline (T0/Intake), completion of 
intervention (2 months, depending on individual condition) or drop-out (T1/Exit), and 
follow-up at 3 months (T2/FU) from discharge. Assessment will last for around 60 
minutes for all participants. 

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Intervention 
ACT and Exercise: 
Participants with chronic pain will participate in an intervention program given twice a 
week for 8 weeks. ACT designed for chronic pain will be conducted by register Clinical 
Psychologist, and co-facilitated by registered social workers who are trained by this 
project and employed by the NGOs. The trained peer supporters will be matched to 
individual older adults to walk them through the process with regular follow-up. 
Exercise training program would be designed and instructed by an Exercise Specialist 
and trained exercise coach. 
 
Art and Exercise: 
Similar to the experimental group, participants with chronic pain will participate in the 
sham program twice a week for 8 weeks. The Art program, conducted by an art therapist 
and research assistants, and will be co-facilitated by the project officers who are trained 
by this project and employed by the NGOs. Trained peer supporters will be matched to 
individual older adults to walk them through the process with regular follow-up if 
necessary. Exercise training program would be designed and instructed by an Exercise 
Specialist and trained exercise coach. 
 
Measurements 
Basic demographics including age, gender will be collected. 
 
Primary Outcomes 
1. Feeling and Function in existence of pain: Brief Pain Inventory (BPI) (Cleeland, 
1994) aims to evaluate the individual’s pain experience and its effect on physical 
function on daily activities. The tool consists of 11 items, using an 11-point rating, 
of which 0 indicates not interference and 10 as interferes completely. The 
Cronbach’s alpha coefﬁcients for interference and severity subscales were .88 and 
0.80 respectively (Cleeland, 1991). A validation on the Taiwanese population of 
BPI (BPI-T) was done by Ger et al in 1999. 
 
2. Depression: The Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & 
Williams, 2001): a 9-item instrument that incorporates depression diagnostic 
criteria with other leading major depressive symptoms, and rates the frequency of 
the symptoms which factors into the scoring severity index. PHQ-9 scores of 5-9, 

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10-14, 15-19, 20 and above represent mild, moderate, moderately severe, and severe 
depression. The Cronbach’s alpha coefﬁcients for Primary Care Study and Ob-Gyn 
Study were .89 and 0.86 respectively. A validation on the Chinese version of PHQ- 9 was 
done by Yeung, Y. in 2010. 
 
Secondary Outcomes 
3. Anxiety: Generalized anxiety disorder scale (GAD-2) (Plummer et al., 2016; Seo & 
Park, 2015): a 2-items self-report to determine the person’s level of anxiety. Each 
item is rated on a 4-point scale ranging from 0 (not at all) to 3 (nearly everyday), 
where higher scores indicate higher anxiety levels. This scale has a Cronbrach’s 
alpha of 082 (Seo & Park, 2015). A validated Chinese version was done by Luo et 
al in 2019. 
 
4. Psychological Flexibility: CompACT-SF (Morris, 2019), also known as 
CompACT-8 aims to evaluate the individual’s psychological flexibility. The tool 
consists of 8 items, using a 7-point rating of which 0 represents strongly disagree 
and 6 as strongly agree, of which higher score represents higher psychological 
flexibility. The scale demonstrated internal reliability of (α > .73). 
 
5. Pain Self-Efficacy-2 (PSEQ-2) (Nicholas et al., 2015): a 2-items self-report to 
evaluate the individual’s confidence level in performing each of the activities 
despite of their pain. Each item is rated on a 7-point scale ranging from 0 (not at all 
confident) to 6 (completely confident), of which higher scores indicate stronger 
self-efficacy. This instrument has a Cronbach’s alpha coefﬁcient of 0.76. A 
validation on the Chinese version of PSEQ-2 was done by Yang et al. in 2019. 
 
6. Quality of life: SF-12 Health Survey (Luo, 2003): a 12-items self-report to evaluate 
the person’s quality of life based on the scores of 2 subscales: Physical component 
score (PCS) and Mental component score (MCS). The scale has a Cronbach alpha 
coefficient of 0.77 for PCS-12 and 0.80 for MCS. A validation on Hong Kong 
Chinese was done by Lam et al in 2005. 
 
 
 
 

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Physical Assessment 
The purpose of a physical assessment of physical functioning of the elderly prior 
entering an exercise program is to identify the individuals at risk and 
effectiveness of the program design. 
 
1. The participant will have their heart rate and blood pressured measured to 
determine if they are at risk of high blood pressure, of which was one of the 
leading cause of death and disability in 2010 usually due to unhealthy diet 
habits, higher percentage of body fat, and physical inactivity (Whelton, P.K. et 
al, 2018). This can further be supported by the measurements from the 
Bioelectrical Impedance Analysis (BIA) scale (Kabiri et al, 2015) to determine 
the individuals body composition. 
 
2. As mentioned previously, risk of falling is closely associated with physical 
disability and chronic pain. Hence the participant will be assessed on mobility, 
lower body muscle strength, and balance ability to determine the effectiveness 
of the intervention: 
a. Timed Up and Go (TUG) (Podsiadlo and Richardson 1991): a chair 
with handle is placed 3m away from an obstacle. The individual is 
instructed to rise from the chair without touching the handles, walk to 
the point then return to the chair in a seated position as quickly as 
possible. The rating is based on the number of seconds it takes for the 
individual to return to initial position where: less than 10 sec. is 
normal, less than 20 sec. is independent and can displace without aid, 
and lastly, less than 30 sec. demonstrates that that individual has 
difficulty walking and requires assistance with daily activity. 
 
b. 4-Stage Balance Test “modified” (Phelan et al, 2015): requires the 
individual to stand in 4 different positions progressively for 10 sec. 
each. The 4 positions include: stand with feet side-by-side, place the 
instep of one foot next to the other foot’s big toe, tandem stand, and 
stand with one foot. If the tandem stand cannot be held for 10 sec. 
indicates that the elderly is at risk of falling. 
 
c. 30 seconds sit to stand test (Rikli, R.E. & Jones, C.J., 2001): the 

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individual is instructed to sit in the middle of the chair (17 inches from 
the ground) with hand across the chest and both feet flat on the ground. 
With back straight, the individual is to rise from the chair to a standing 
position then return to sitting position for 30 seconds. The score is 
compared with the norm to evaluate on the risk of fall. This test is 
chosen over other sit to stand tests because of its ability to differentiate 
the lower strength ability among wider range of older adults with a 
intraclass correlation coefficient and valid measurement for lower body 
strength is 0.89 and 0.77 respectively (Rikli, R.E. & Jones, C.J., 1999). 
 
3. Physical functioning is also assessed to determine their capability in 
performing daily activities involving the upper body: 
a. Grip strength (Lino et al, 2016) is commonly used as a biomarker for 
elderly’s health status (Bohannon, 2019): The individual is asked to sit 
with their back straight arms straight on the side. The dynamometer set 
at the second handle will be squeezed as hard as possible alternating 
hands after trial. 2 trials will be taken on each hand and the sum of it 
will be calculated. 
4. Aerobic is assessed using the 2-Minute Step Test (Johnston et al, 1999) : The 
individual is instructed to lift their knee to the height halfway between iliac 
crest to patella for a total of 2 minutes. The score is the number achieved with 
the right knee throughout 2 minutes at the given height. 
 
Data Analysis 
Data will be analysed using a pre-post analysis based on different time points. For the 
main outcome measures of depressive symptoms/risks, wellbeing, and personal 
recovery, mixed ANOVA will be used to assess changes from T0/Intake to T1/exit 
between the two groups. To test for sustained effect after completion of intervention, 
mixed ANOVA will be used to assess depressive symptoms/risks, wellbeing, pain 
acceptance, physical ability, and symptoms of pain from T1/Exit to T2/FU within- and 
between- subjects. All results will be reported with the appropriate effect sizes, along 
with statistical significance and confidence intervals. 

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