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

Investigation of the Effect of Acceptance and Commitment Therapy and Exercise in Older Adults With Chronic Pain: A Randomized Controlled Trial

The objective is to investigate on the effectiveness of Acceptance and Commitment Therapy and Exercise in:

(Primary outcomes)

1. Increasing psychological flexibility
2. Reducing pain interference
3. Increasing quality of life

4. Increasing physical functioning

   (Secondary outcomes)

5. Reducing psychological distress - depression & anxiety

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Exercise; Older Adults; Acceptance and Commitment Therapy; Psychosocial Intervention; Art
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy (ACT); Other: Exercise; Other: Art; Other: Treatment as usual

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tianyin (Bridget) Liu, PhD; Phone Number: (+852) 39170081; Email: tianyin@hku.hk
• Study Contact Backup: Name: Annabelle P.C. Fong, Bsc; Phone Number: (+852) 39102113; Email: annabellef@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The University of Hong Kong
    • Contact: Tianyin Liu, PhD; Phone Number: (+852) 39170081; Email: tianyin@hku.hk
    • Principal Investigator: Terry Y.S. Lum, PhD
    • Principal Investigator: Gloria Wong, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acceptance and Commitment Therapy (ACT) and Exercise; This group receives eight weeks' Acceptance and Commitment Therapy (ACT) and exercise intervention.	Behavioral: Acceptance and Commitment Therapy (ACT); 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.; Other: Exercise; 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.
Sham Comparator: Art and Exercise; This group receives eight weeks' art workshops (skill-based) and exercise intervention.	Other: Exercise; 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.; Other: Art; 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.
Active Comparator: Treatment as usual; This group receives treatment as usual in the local community setting.	Other: Treatment as usual; treatment as usual within their community centres

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity and interference at 3-month follow up	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.	3-month follow-up after T1
Psychological flexibility at 3-month follow up	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.	3-month follow-up after T1
Health-related quality of life at 3-month follow up	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.	3-month follow-up after T1
Gait speed at 3-month follow up	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.	3-month follow-up after T1
Physical balance at 3-month follow up	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.	3-month follow-up after T1
Lower body strength at 3-month follow up	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.	3-month follow-up after T1
Upper body functioning at 3-month follow up	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	3-month follow-up after T1
Aerobic fitness at 3-month follow up	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	3-month follow-up after T1
Pain self-efficacy at 3-month follow up	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	3-month follow-up after T1
Depression at 3-month follow up	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.	3-month follow-up after T1
Anxiety at 3-month follow up	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.	3-month follow-up after T1

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: The Hong Kong Jockey Club Charities Trust; Hong Kong Young Women's Christian Association; Caritas Medical Centre, Hong Kong; Hong Kong Sheng Kung Hui Welfare Council Limited; The Neighbourhood Advice-Action Council; Aberdeen Kai-fong Welfare Association
• Investigators: Principal Investigator: Terry Y.S. Lum, PhD, Department of Social Work and Social Administration, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: EA200132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No