The Feasibility, Potential Efficacy, and Experiences of Using a Group-based Acceptance and Commitment Therapy Among Older People With Chronic Low Back Pain

Study Overview
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Brief Summary
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No study has investigated the effects of ACT on community-dwelling Chinese older adults. Given that clinical practice guidelines have recommended exercise therapy for treating people with CLBP, a combination of ACT and exercise therapy may yield better clinical outcomes than exercise alone among community-dwelling older adults with CLBP. A double-blinded (participants and statistician) pilot randomized controlled trial (RCT) will be conducted to evaluate the feasibility and the relative effects of ACT plus back exercise training as compared to exercise alone in improving psychological flexibility, physical wellbeing, and quality of life of community-dwelling older people with CLBP. Further, a qualitative research study will be conducted to understand the experiences of participating in ACT and back exercise training in older people with CLBP (including identifying facilitators and barriers to participation).

Detailed Description
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Participants will be recruited from rehabilitation clinics, or community centres by posters posted in these locations. A total of 30 older people with LBP will be recruited and randomized into either a 4-week ACT plus back exercise group, or a back exercise control group. Immediately after the 4-week treatment, participants will be invited to complete another set of questionnaires that are identical to their baseline questionnaires to evaluate the effects of interventions on their pain, physical function, psychological wellbeing, and quality of life. At 3-month post-treatment, participants will be invited to complete the identical questionnaires again.

Official Title
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The Feasibility, Potential Efficacy, and Experiences of Using a Group-based Acceptance and Commitment Therapy Among Older People With Chronic Low Back Pain: a Pilot Randomized Controlled Trial

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Behavioral: Acceptance and commitment therapy (ACT)
* Behavioral: back exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have non-specific LBP in or near the lumbosacral spine with or without leg pain that lasts for at least 3-months in the last 12 months have sought some medical or healthcare professional treatments for CLBP able to read and write at an adequate level of proficiency in Chinese Mini-Mental Status Examination (MMSE) scores 23 or above Exclusion Criteria: people with malignant pain or lumbar spinal stenosis confirmed dementia severe cognitive impairment serious psychiatric or psychological disorders Mini-Mental Status Examination (MMSE) scores below 23

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Older people with ACT intervention<br>4 week ACT plus back exercise group | Behavioral: Acceptance and commitment therapy (ACT)<br>* Each session in the ACT group will include the first hour of ACT intervention followed by 1 hour of back exercise class. The ACT group will be led by a trained ACT counsellor and a trained exercise trainer.<br>Behavioral: back exercise<br>* The control group will undergo 1 hour of back exercise class, while the control group will be led by a trained exercise trainer.<br>|
| Other: Older people without ACT intervention<br>4-week back exercise control group | Behavioral: back exercise<br>* The control group will undergo 1 hour of back exercise class, while the control group will be led by a trained exercise trainer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of psychological flexibility at immediately after the 4-week treatments | The 7-item Chinese version of the Acceptance and Action Questionnaire II (AAQ-II) will be used to measure participants' psychological flexibility. It comprises 7 statements, which are rated on a 7-point scale, where 1 means never true and 7 means always true. The maximum total score is 49. Higher total scores mean less flexibility. AAQ-II has been cross-culturally adapted and validated among local adolescents and has demonstrated satisfactory internal consistency and test-retest reliability. | Baseline and at immediately after the 4-week treatments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of LBP intensity | An 11-point numeric pain rating scale will be used to measure LBP intensity, where 0 means no pain and 10 means the worst imaginable pain. Participants need to report their back pain in the current moment, in the last 24 hours and the last 3 months. | Baseline, immediately after the 4-week treatments, and at 3-month post-treatment | 
| Change of LBP-related disability | The Chinese version of 24-item Roland Morris Disability Index will be used to evaluate the LBP-related disability in older adults.30 It consists of 24 yes/no items related to LBP-related functional limitations. The summation of the scores of items with yes answer indicates the severity of LBP-related disability. The maximum score is 24. | Baseline, immediately after the 4-week treatments, and at 3-month post-treatment | 
| Change of health-related quality of life | The Chinese version of EQ-5D-5L will be used to measure health-related quality of life (HRQOL) in our participants. It comprises 5 items related to mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each item has 5 options (no problem, slight problems, moderate problems, severe problems, extreme problems/unable to). It has been found to useful in monitoring HRQOL responses to treatment. | Baseline, immediately after the 4-week treatments, and at 3-month post-treatment | 
| Change of depression, anxiety, and stress | The Chinese version of 21-item Depression, Anxiety Stress Scales (DASS) will be used to evaluate depression (7 items), anxiety (7 items), and stress (7 items) in older adults. Each item is rated on a 4-point scale ranging from 0 (not at all) to 3 (most of the time). Higher scores imply more mental health issues. It has been cross-culturally adapted to Hong Kong settings. DASS has demonstrated excellent internal consistency for depression, anxiety, and stress subscales. | Baseline, immediately after the 4-week treatments, and at 3-month post-treatment | 
| Overall perceived changes in symptom severity, treatment response and the efficacy of treatment | Global impression of change scale will be used to evaluate the overall perceived changes in symptom severity, treatment response and the efficacy of treatment immediately after the 4 week interventions. | Baseline, immediately after the 4-week treatments, and at 3-month post-treatment | 
| Change from baseline of psychological flexibility at 3-month post-treatment | The 7-item Chinese version of the Acceptance and Action Questionnaire II (AAQ-II) will be used to measure participants' psychological flexibility. It comprises 7 statements, which are rated on a 7-point scale, where 1 means never true and 7 means always true. The maximum total score is 49. Higher total scores mean less flexibility. AAQ-II has been cross-culturally adapted and validated among local adolescents and has demonstrated satisfactory internal consistency and test-retest reliability. | Baseline and at 3-month post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Low-back Pain (CLBP), Acceptance and commitment therapy (ACT), psychological flexibility