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Clinical Trials/NCT05528536
NCT05528536
Completed
Not Applicable

Investigation of the Effect of Acceptance and Commitment Therapy and Exercise in Older Adults With Chronic Pain: A Randomized Controlled Trial

The University of Hong Kong1 site in 1 country163 target enrollmentMay 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
The University of Hong Kong
Enrollment
163
Locations
1
Primary Endpoint
Change from baseline pain intensity and interference at 8 weeks
Status
Completed
Last Updated
9 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2022
End Date
January 19, 2024
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Professor Terry Y.S. Lum

Henry G. Leong Professor in Social Work and Social Administration; Principal Investigator of the JC JoyAge project

The University of Hong Kong

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change from baseline anxiety at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))
  • Change from baseline psychological flexibility at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))
  • Change from baseline pain self-efficacy at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))
  • Change from baseline health-related quality of life at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))
  • Change from baseline gait speed at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))
  • Change from baseline physical balance at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))
  • Change from baseline lower body strength at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))
  • Change from baseline upper body functioning at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))
  • Change from baseline aerobic fitness at 8 weeks(Baseline(T0) and 8 weeks after baseline (T1))

Study Sites (1)

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