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

Primary Purpose

Chronic Pain, Older Adults, Acceptance and Commitment Therapy

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy (ACT)
Art
Exercise
Treatment as usual
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

Acceptance and Commitment Therapy (ACT) and Exercise

Art and Exercise

Treatment as usual

Arm Description

This group receives eight weeks' Acceptance and Commitment Therapy (ACT) and exercise intervention.

This group receives eight weeks' art workshops (skill-based) and exercise intervention.

This group receives treatment as usual in the local community setting.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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
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
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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 11, 2022
Last Updated
August 31, 2022
Sponsor
The University of Hong Kong
Collaborators
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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1. Study Identification

Unique Protocol Identification Number
NCT05528536
Brief Title
Acceptance and Commitment Therapy and Exercise for Older Adults With Chronic Pain
Official Title
Investigation of the Effect of Acceptance and Commitment Therapy and Exercise in Older Adults With Chronic Pain: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Older Adults, Acceptance and Commitment Therapy, Exercise, Psychosocial Intervention, Art

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acceptance and Commitment Therapy (ACT) and Exercise
Arm Type
Experimental
Arm Description
This group receives eight weeks' Acceptance and Commitment Therapy (ACT) and exercise intervention.
Arm Title
Art and Exercise
Arm Type
Sham Comparator
Arm Description
This group receives eight weeks' art workshops (skill-based) and exercise intervention.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
This group receives treatment as usual in the local community setting.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy (ACT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Art
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
treatment as usual within their community centres
Primary Outcome Measure Information:
Title
Change from baseline pain intensity and interference at 8 weeks
Description
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.
Time Frame
Baseline(T0) and 8 weeks after baseline (T1)
Title
Change from baseline psychological flexibility at 8 weeks
Description
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.
Time Frame
Baseline(T0) and 8 weeks after baseline (T1)
Title
Change from baseline health-related quality of life at 8 weeks
Description
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.
Time Frame
Baseline(T0) and 8 weeks after baseline (T1)
Title
Change from baseline gait speed at 8 weeks
Description
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.
Time Frame
Baseline(T0) and 8 weeks after baseline (T1)
Title
Change from baseline physical balance at 8 weeks
Description
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.
Time Frame
Baseline(T0) and 8 weeks after baseline (T1)
Title
Change from baseline lower body strength at 8 weeks
Description
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.
Time Frame
Baseline(T0) and 8 weeks after baseline (T1)
Title
Change from baseline upper body functioning at 8 weeks
Description
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
Time Frame
Baseline(T0) and 8 weeks after baseline (T1)
Title
Change from baseline aerobic fitness at 8 weeks
Description
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
Time Frame
Baseline(T0) and 8 weeks after baseline (T1)
Title
Change from baseline pain self-efficacy at 8 weeks
Description
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
Time Frame
Baseline(T0) and 8 weeks after baseline (T1)
Secondary Outcome Measure Information:
Title
Change from baseline depression at 8 weeks
Description
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.
Time Frame
Baseline(T0) and 8 weeks after baseline (T1)
Title
Change from baseline anxiety at 8 weeks
Description
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.
Time Frame
Baseline(T0) and 8 weeks after baseline (T1)
Other Pre-specified Outcome Measures:
Title
Pain intensity and interference at 3-month follow up
Description
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.
Time Frame
3-month follow-up after T1
Title
Psychological flexibility at 3-month follow up
Description
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.
Time Frame
3-month follow-up after T1
Title
Health-related quality of life at 3-month follow up
Description
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.
Time Frame
3-month follow-up after T1
Title
Gait speed at 3-month follow up
Description
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.
Time Frame
3-month follow-up after T1
Title
Physical balance at 3-month follow up
Description
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.
Time Frame
3-month follow-up after T1
Title
Lower body strength at 3-month follow up
Description
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.
Time Frame
3-month follow-up after T1
Title
Upper body functioning at 3-month follow up
Description
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
Time Frame
3-month follow-up after T1
Title
Aerobic fitness at 3-month follow up
Description
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
Time Frame
3-month follow-up after T1
Title
Pain self-efficacy at 3-month follow up
Description
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
Time Frame
3-month follow-up after T1
Title
Depression at 3-month follow up
Description
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.
Time Frame
3-month follow-up after T1
Title
Anxiety at 3-month follow up
Description
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.
Time Frame
3-month follow-up after T1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tianyin (Bridget) Liu, PhD
Phone
(+852) 39170081
Email
tianyin@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Annabelle P.C. Fong, Bsc
Phone
(+852) 39102113
Email
annabellef@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Y.S. Lum, PhD
Organizational Affiliation
Department of Social Work and Social Administration, The University of Hong Kong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gloria Wong, PhD
Organizational Affiliation
Department of Social Work and Social Administration, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianyin Liu, PhD
Phone
(+852) 39170081
Email
tianyin@hku.hk
First Name & Middle Initial & Last Name & Degree
Terry Y.S. Lum, PhD
First Name & Middle Initial & Last Name & Degree
Gloria Wong, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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