Acceptance and Commitment Therapy and Exercise for Older Adults With Chronic Pain

Study Overview
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Brief Summary
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The objective is to investigate on the effectiveness of Acceptance and Commitment Therapy and Exercise in: (Primary outcomes) Increasing psychological flexibility Reducing pain interference Increasing quality of life Increasing physical functioning (Secondary outcomes) Reducing psychological distress - depression & anxiety

Detailed Description
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Chronic pain is classified as persistent or recurrent pain for more than 3 months associated with physical disability, depression and poor psychosocial functioning among older adults; causing a dependence on medication and decreasing their quality of life. There are various treatment options from chronic pain, but the benefits on pain outcomes are minimal and rather short term. Psychological interventions, such as acceptance and commitment therapy (ACT), have shown positive effect on older adults with chronic pain. Using the three core elements of psychological flexibility, older adults are encouraged to establish a different relationship with pain: 1) be present; 2) do what matters; and 3) open up. Growing studies are exploring the application of biopsychosocial model in pain management, using multidisciplinary interventions. This RCT aims to explore the effectiveness of combining ACT and exercise with two arms: 1) art and exercise; and 2) treatment as usual.

Official Title
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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

Conditions
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Art, Exercise, Psychosocial Intervention, Chronic Pain, Older Adults, Acceptance and Commitment Therapy

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy (ACT)
* Other: Art
* Other: Exercise
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acceptance and Commitment Therapy (ACT) and Exercise<br>This group receives eight weeks' Acceptance and Commitment Therapy (ACT) and exercise intervention. | Behavioral: Acceptance and Commitment Therapy (ACT)<br>* A two-hour ACT will focus on enhancing participant's psychological flexibility towards pain. All sessions will be delivered face-to-face within their local community centre.<br>Other: Exercise<br>* An hour of low-to-moderate resistance exercise aims to increase their strength and balance. All sessions will be delivered face-to-face within their local community centre.<br>|
| Sham Comparator: Art and Exercise<br>This group receives eight weeks' art workshops (skill-based) and exercise intervention. | Other: Art<br>* To be comparable with the experimental group, the Art session will be a two-hour long session which aims to share different art techniques, without any active components. All sessions will be delivered face-to-face within their local community centre.<br>Other: Exercise<br>* An hour of low-to-moderate resistance exercise aims to increase their strength and balance. All sessions will be delivered face-to-face within their local community centre.<br>|
| Active Comparator: Treatment as usual<br>This group receives treatment as usual in the local community setting. | Other: Treatment as usual<br>* treatment as usual within their community centres<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline pain intensity and interference at 8 weeks | Brief pain inventory (BPI) is used to measure pain intensity and interference, it is a 11 items scale, using an 11-point rating, of which 0 indicates not interference and 10 as interferes completely. The higher the numbers, the greater the pain intensity and pain interference. | Baseline(T0) and 8 weeks after baseline (T1) | 
| Change from baseline psychological flexibility at 8 weeks | The Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT-SF) scale is used to measure psychological flexibility, it is an 8-items scale, using a 7-point rating of which 0 represents strongly disagree and 6 as strongly agree. Higher scores represent higher psychological flexibility. 3 subscales: Value Action Subscale, Openness to Experience, Behavioural Awareness, of which questions 2,3,4,7 are reverse scored. | Baseline(T0) and 8 weeks after baseline (T1) | 
| Change from baseline health-related quality of life at 8 weeks | The 12-Item Short-Form Survey (SF-12) is used to measure health-related quality of life, it is a 12 items scale, consisting of 2 subscales: Physical component score (PCS) and Mental component score (MCS). Max. score 100, higher scores indicate better physical functioning and mental health. | Baseline(T0) and 8 weeks after baseline (T1) | 
| Change from baseline gait speed at 8 weeks | Time up and go (TUG) is used to measure gait speed. A chair with handles is placed 3m away from an obstacle, participants are 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 the 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. | Baseline(T0) and 8 weeks after baseline (T1) | 
| Change from baseline physical balance at 8 weeks | A modified 4-Stage balanced test is used to measure physical balance, it requires the individual to stand in 4 different positions progressively for 10 seconds 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. | Baseline(T0) and 8 weeks after baseline (T1) | 
| Change from baseline lower body strength at 8 weeks | 30 seconds sit to stand test is used to measure lower body strength. The participants are instructed to sit in the middle of the chair (17 inches from the ground) with hands across the chest and both feet flat on the ground. With the back straight, the participants are to rise from the chair to a standing position and then return to the sitting position for 30 seconds. The score is compared with the norm to evaluate the risk of falls. | Baseline(T0) and 8 weeks after baseline (T1) | 
| Change from baseline upper body functioning at 8 weeks | Grip Strength is used to measure upper body functioning. The individual is asked to sit with their back straight and 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. The results will be compared to the norms to determine the participant's level of upper body functioning | Baseline(T0) and 8 weeks after baseline (T1) | 
| Change from baseline aerobic fitness at 8 weeks | 2-min step test is used to test aerobic fitness. The individual is instructed to lift their knee to the height halfway between the iliac crest and to the patella for a total of 2 minutes. The score is the number achieved with the right knee throughout 2 minutes at the given height. The scores will then be compared to norms to determine the participant's level of aerobic fitness | Baseline(T0) and 8 weeks after baseline (T1) | 
| Change from baseline pain self-efficacy at 8 weeks | The Pain Self-Efficacy Questionnaire (PSEQ-2) is used to measure pain self-efficacy. It is a 2-items self-report, 7-point scale ranging from 0 (not at all confident) to 6 (completely confident), of which higher scores indicate stronger self-efficacy. Max score 12 | Baseline(T0) and 8 weeks after baseline (T1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline depression at 8 weeks | The Patient Health Questionnaire (PHQ-9) is used to measure depression, it is a 9-item instrument, PHQ-9 scores of 5-9, 10-14, 15-19, 20 and above represent mild, moderate, moderately severe, and severe depression. Scores range between 0 and 27. | Baseline(T0) and 8 weeks after baseline (T1) | 
| Change from baseline anxiety at 8 weeks | The Generalised Anxiety Disorder (GAD-2) is used to measure anxiety, it is a 2-item scale, each item is rated on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day), where higher scores indicate higher anxiety levels. Scores range between 0 and 21. | Baseline(T0) and 8 weeks after baseline (T1) |