Clinical trial NCT05528536: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Older Adults
Acceptance and Commitment Therapy
Exercise
Psychosocial Intervention
Art
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Jockey Club Charities Trust
name: Aberdeen Kai-fong Welfare Association
name: Caritas Medical Centre, Hong Kong
name: Hong Kong Sheng Kung Hui Welfare Council Limited
name: Hong Kong Young Women's Christian Association
name: Neighbourhood Advice-Action Council
First posted: 2022-09-06
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

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

Primary outcomes:
measure: Change from baseline pain intensity and interference at 8 weeks
timeFrame: Baseline(T0) and 8 weeks after baseline (T1)
measure: Change from baseline psychological flexibility at 8 weeks
timeFrame: Baseline(T0) and 8 weeks after baseline (T1)
measure: Change from baseline health-related quality of life at 8 weeks
timeFrame: Baseline(T0) and 8 weeks after baseline (T1)
measure: Change from baseline gait speed at 8 weeks
timeFrame: Baseline(T0) and 8 weeks after baseline (T1)
measure: Change from baseline physical balance at 8 weeks
timeFrame: Baseline(T0) and 8 weeks after baseline (T1)
measure: Change from baseline lower body strength at 8 weeks
timeFrame: Baseline(T0) and 8 weeks after baseline (T1)
measure: Change from baseline upper body functioning at 8 weeks
timeFrame: Baseline(T0) and 8 weeks after baseline (T1)
measure: Change from baseline aerobic fitness at 8 weeks
timeFrame: Baseline(T0) and 8 weeks after baseline (T1)
measure: Change from baseline pain self-efficacy at 8 weeks
timeFrame: Baseline(T0) and 8 weeks after baseline (T1)
Secondary outcomes:
measure: Change from baseline depression at 8 weeks
timeFrame: Baseline(T0) and 8 weeks after baseline (T1)
measure: Change from baseline anxiety at 8 weeks
timeFrame: Baseline(T0) and 8 weeks after baseline (T1)
Other outcomes:
measure: Pain intensity and interference at 3-month follow up
timeFrame: 3-month follow-up after T1
measure: Psychological flexibility at 3-month follow up
timeFrame: 3-month follow-up after T1
measure: Health-related quality of life at 3-month follow up
timeFrame: 3-month follow-up after T1
measure: Gait speed at 3-month follow up
timeFrame: 3-month follow-up after T1
measure: Physical balance at 3-month follow up
timeFrame: 3-month follow-up after T1
measure: Lower body strength at 3-month follow up
timeFrame: 3-month follow-up after T1
measure: Upper body functioning at 3-month follow up
timeFrame: 3-month follow-up after T1
measure: Aerobic fitness at 3-month follow up
timeFrame: 3-month follow-up after T1
measure: Pain self-efficacy at 3-month follow up
timeFrame: 3-month follow-up after T1
measure: Depression at 3-month follow up
timeFrame: 3-month follow-up after T1
measure: Anxiety at 3-month follow up
timeFrame: 3-month follow-up after T1
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: Department of Social Work and Social Administration, The University of Hong Kong
name: Terry Y.S. Lum, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Social Work and Social Administration, The University of Hong Kong
name: Gloria Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: