Acceptance and Commitment Therapy, Art, Chronic Pain, Exercise, Older Adults, Psychosocial Intervention
Conditions
Brief summary
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.
Interventions
BEHAVIORALAcceptance 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.
OTHERArt
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.
OTHERExercise
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.
OTHERTreatment as usual
treatment as usual within their community centres
Sponsors
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
Neighbourhood Advice-Action Council
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline pain intensity and interference at 8 weeks | Baseline(T0) and 8 weeks after baseline (T1) | 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 depression at 8 weeks | Baseline(T0) and 8 weeks after baseline (T1) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline anxiety at 8 weeks | Baseline(T0) and 8 weeks after baseline (T1) | 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. |
| Change from baseline psychological flexibility at 8 weeks | Baseline(T0) and 8 weeks after baseline (T1) | 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 pain self-efficacy at 8 weeks | Baseline(T0) and 8 weeks after baseline (T1) | 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 |
| Change from baseline health-related quality of life at 8 weeks | Baseline(T0) and 8 weeks after baseline (T1) | 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 | Baseline(T0) and 8 weeks after baseline (T1) | 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 | Baseline(T0) and 8 weeks after baseline (T1) | 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 | Baseline(T0) and 8 weeks after baseline (T1) | 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 | Baseline(T0) and 8 weeks after baseline (T1) | 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 | Baseline(T0) and 8 weeks after baseline (T1) | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity and interference at 3-month follow up | 20 weeks after baseline (T2) | 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. |
| Anxiety at 3-month follow up | 20 weeks after baseline (T2) | 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. |
| Depression at 3-month follow up | 20 weeks after baseline (T2) | 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. |
| Psychological flexibility at 3-month follow up | 20 weeks after baseline (T2) | 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. |
| Pain self-efficacy at 3-month follow up | 20 weeks after baseline (T2) | 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 |
| Health-related quality of life at 3-month follow up | 20 weeks after baseline (T2) | 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. |
| Gait speed at 3-month follow up | 20 weeks after baseline (T2) | 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. |
| Physical balance at 3-month follow up | 20 weeks after baseline (T2) | 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. |
| Lower body strength at 3-month follow up | 20 weeks after baseline (T2) | 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. |
| Upper body functioning at 3-month follow up | 20 weeks after baseline (T2) | 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 |
| Aerobic fitness at 3-month follow up | 20 weeks after baseline (T2) | 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 |
Countries
Hong Kong
Outcome results
None listed