Acceptance and Commitment Therapy and Exercise for Older Adults With Chronic Pain

Not Applicable

• Conditions: Chronic Pain; Acceptance and Commitment Therapy; Exercise; Psychosocial Intervention; Older Adults; Art
• Interventions: Behavioral: Acceptance and Commitment Therapy (ACT); Other: Treatment as usual; Other: Art; Other: Exercise

• Registration Number: NCT05528536
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2022-02-11
• Study Start: 2022-05-15
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-31
• Last Update Submitted: 2022-08-31
• Study First Posted: 2022-09-06
• Last Update Posted: 2022-09-06
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acceptance and Commitment Therapy (ACT) and Exercise	Acceptance and Commitment Therapy (ACT)	This group receives eight weeks' Acceptance and Commitment Therapy (ACT) and exercise intervention.
Acceptance and Commitment Therapy (ACT) and Exercise	Exercise	This group receives eight weeks' Acceptance and Commitment Therapy (ACT) and exercise intervention.
Treatment as usual	Treatment as usual	This group receives treatment as usual in the local community setting.
Art and Exercise	Art	This group receives eight weeks' art workshops (skill-based) and exercise intervention.
Art and Exercise	Exercise	This group receives eight weeks' art workshops (skill-based) and exercise intervention.

Primary Outcome Measures

Name	Time	Method
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 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 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 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
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 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 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 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

Secondary Outcome Measures

Name	Time	Method
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 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.

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong