Chronic PainNCT05528536
Acceptance and Commitment Therapy and Exercise for Older Adults With Chronic Pain
A study testing Acceptance and Commitment Therapy (ACT), Art and Exercise in people with Chronic Pain and Older Adults, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Pain, Older Adults, Acceptance and Commitment Therapy
- What is being tested?
- Acceptance and Commitment Therapy (ACT), Art and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 May 2022to 19 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Acceptance and Commitment Therapy and Exercise in Older Adults With Chronic Pain: A Randomized Controlled Trial
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.
- Conditions
- Chronic Pain, Older Adults, Acceptance and Commitment Therapy, Exercise, Psychosocial Intervention, Art
- Being tested
- Acceptance and Commitment Therapy (ACT), Art, Exercise, Treatment as usual
- Medical subject headings
- Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
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.
ArtOther
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.
ExerciseOther
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 usualOther
treatment as usual within their community centres
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) and Exercise | Experimental | This group receives eight weeks' Acceptance and Commitment Therapy (ACT) and exercise intervention. Receives: Behavioral: Acceptance and Commitment Therapy (ACT); Other: Exercise |
| Art and Exercise | Sham comparator | This group receives eight weeks' art workshops (skill-based) and exercise intervention. Receives: Other: Art; Other: Exercise |
| Treatment as usual | Active comparator | This group receives treatment as usual in the local community setting. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline(T0) and 8 weeks after baseline (T1)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline(T0) and 8 weeks after baseline (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start15 May 2022
- Primary completion31 Dec 2023
- Study completion19 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- 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, Neighbourhood Advice-Action Council
- Responsible party
- Principal investigator, Professor Terry Y.S. Lum, The University of Hong Kong
- Investigators
- Terry Y.S. Lum, PhD, Principal investigator, Department of Social Work and Social Administration, The University of Hong KongGloria Wong, PhD, Principal investigator, School of Psychology and Clinical Language Sciences, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528536
- Sponsor's protocol ID
- EA200132
- Status last verified
- Jul 2025
- First submitted
- 11 Feb 2022
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Acceptance and Commitment Therapy and Exercise in Older Adults With Chronic Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05528536
- Acronym / sponsor ID
- EA200132
- Conditions
- Chronic Pain, Older Adults, Acceptance and Commitment Therapy, Exercise, Psychosocial Intervention, Art
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- 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, Neighbourhood Advice-Action Council
- Study start
- 15 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) and Exercise | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT), Other: ExerciseThis group receives eight weeks' Acceptance and Commitment Therapy (ACT) and exercise intervention. |
| Art and Exercise | Sham comparator | Other: Art, Other: ExerciseThis group receives eight weeks' art workshops (skill-based) and exercise intervention. |
| Treatment as usual | Active comparator | Other: Treatment as usualThis group receives treatment as usual in the local community setting. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Acceptance and Commitment Therapy (ACT) and Exercise |
| ArtTo 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. | Other | Art and Exercise |
| ExerciseAn 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 | Acceptance and Commitment Therapy (ACT) and Exercise, Art and Exercise |
| Treatment as usualtreatment as usual within their community centres | Other | Treatment as usual |
Primary outcome
Change from baseline pain intensity and interference at 8 weeks
Time frame: 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
Time frame: 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.
9 secondary outcomes
Change from baseline anxiety at 8 weeks
Time frame: Baseline(T0) and 8 weeks after baseline (T1)
Change from baseline psychological flexibility at 8 weeks
Time frame: Baseline(T0) and 8 weeks after baseline (T1)
Change from baseline pain self-efficacy at 8 weeks
Time frame: Baseline(T0) and 8 weeks after baseline (T1)
Change from baseline health-related quality of life at 8 weeks
Time frame: Baseline(T0) and 8 weeks after baseline (T1)
Change from baseline gait speed at 8 weeks
Time frame: Baseline(T0) and 8 weeks after baseline (T1)
Change from baseline physical balance at 8 weeks
Time frame: Baseline(T0) and 8 weeks after baseline (T1)
Change from baseline lower body strength at 8 weeks
Time frame: Baseline(T0) and 8 weeks after baseline (T1)
Change from baseline upper body functioning at 8 weeks
Time frame: Baseline(T0) and 8 weeks after baseline (T1)
Change from baseline aerobic fitness at 8 weeks
Time frame: Baseline(T0) and 8 weeks after baseline (T1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Y.S. Lum, PhD principal investigator
Department of Social Work and Social Administration, The University of Hong Kong
Gloria Wong, PhD principal investigator
School of Psychology and Clinical Language Sciences, University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT), Art and Exercise in people with Chronic Pain and Older Adults, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pain intensity and interference at 8 weeks (time frame: Baseline(T0) and 8 weeks after baseline (T1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.