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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05528536
• Other study ID #: EA200132
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2022
• Source: The University of Hong Kong
• Contact: Tianyin (Bridget) Liu, PhD
• Phone: (+852) 39170081
• Email: tianyin[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

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:
• 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.
• 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.
• Treatment as usual
treatment as usual within their community centres

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (7)

Lead Sponsor	Collaborator
The University of Hong Kong	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 (YWCA), The Hong Kong Jockey Club Charities Trust, The Neighbourhood Advice-Action Council

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)