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| Name | Class |
|---|---|
| The Hong Kong Jockey Club Charities Trust | OTHER |
| Aberdeen Kai-fong Welfare Association | OTHER |
| Caritas Medical Centre, Hong Kong | OTHER |
| Hong Kong Sheng Kung Hui Welfare Council Limited |
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The goal of this trial is to learn if combining Acceptance and Commitment Therapy (ACT) and exercise works to reduce pain intensity, pain interference, and depressive symptoms in older adults with chronic pain and depressive symptoms.
Researchers will compare ACT + exercise intervention (ACEx) to ACT + art intervention (Art+Ex) and usual care to see if ACT + exercise intervention works to reduce pain intensity, pain interference, and depressive symptoms.
Participants will receive ACEx program, Art+Ex program, or usual care for 8 weeks and complete tests before and after the programs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance and Commitment Therapy (ACT) and Exercise | Experimental | This group receives eight weeks' Acceptance and Commitment Therapy (ACT) and exercise intervention. |
|
| Art and Exercise | Sham Comparator | This group receives eight weeks' art workshops (skill-based) and exercise intervention. |
|
| Treatment as usual | Active Comparator | This group receives treatment as usual in the local community setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Behavioral | 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. |
| 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 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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. | 20 weeks after baseline (T2) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terry Y.S. Lum, PhD | Department of Social Work and Social Administration, The University of Hong Kong | Principal Investigator |
| Gloria Wong, PhD | School of Psychology and Clinical Language Sciences, University of Reading | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Hong Kong | Hong Kong | Hong Kong |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 7, 2022 | Mar 25, 2025 |
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| OTHER |
| Hong Kong Young Women's Christian Association | OTHER |
| Neighbourhood Advice-Action Council | OTHER |
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| Art | Other | 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 | Other | 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 | Other | treatment as usual within their community centres |
|
| 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 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) |
| 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) |
| 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. | 20 weeks after baseline (T2) |
| 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. | 20 weeks after baseline (T2) |
| 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. | 20 weeks after baseline (T2) |
| 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 | 20 weeks after baseline (T2) |
| 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. | 20 weeks after baseline (T2) |
| 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. | 20 weeks after baseline (T2) |
| 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. | 20 weeks after baseline (T2) |
| 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. | 20 weeks after baseline (T2) |
| 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 | 20 weeks after baseline (T2) |
| 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 | 20 weeks after baseline (T2) |
| Prot_001.pdf |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| D027724 | Reproductive Techniques, Assisted |
| D015444 | Exercise |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D012099 | Reproductive Techniques |
| D008919 | Investigative Techniques |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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