Feasibility, Effectiveness, and Patient Experience of Online Acceptance and Commitment Therapy Plus Exercises for Older People With Chronic Low Back Pain
- Conditions
- Chronic Low-back Pain
- Interventions
- Behavioral: back exerciseBehavioral: Acceptance and Commitment Therapy (ACT)Behavioral: back care education
- Registration Number
- NCT06576414
- Lead Sponsor
- The Hong Kong Polytechnic University
- Brief Summary
No study has investigated the effects of online ACT on community-dwelling 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 online ACT plus back exercise training as compared to exercise alone in improving psychological flexibility, physical well-being, and quality of life of community-dwelling older people with CLBP at different time points. The clinical outcomes will be measured at baseline, immediately after the 4-week treatment, and at the 3- and 6-month post-treatment follow-ups. Further, a qualitative research study will be conducted to understand the experiences of participating in online ACT and back exercise training in older people with CLBP (including identifying facilitators and barriers to participation).
- Detailed Description
Recruitment posters will be displayed in five Hong Kong community centers. A total of 40 older people with LBP will be recruited and randomized to either a 4-week online ACT-plus-back-exercise group or a 4-week online spine care education-back-exercise control group. All participants will be screened for eligibility.
After providing the informed consent, participants will undergo baseline assessments. Then they will be randomized into either group. Immediately after the 4-week treatment and at 3- and 6-month post-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 well-being, and quality of life.
Semi-structured interviews will be conducted to collect the user experience of participants in both groups by purposive sampling. The interviews will be conducted immediately post-treatment and at the 6-month post-treatment follow-up to evaluate the perspectives at different time points.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Older people without ACT intervention back care education 4-week back exercise control group Older people without ACT intervention back exercise 4-week back exercise control group Older people with online ACT intervention Acceptance and Commitment Therapy (ACT) 4 week ACT plus back exercise group Older people with online ACT intervention back exercise 4 week ACT plus back exercise group
- Primary Outcome Measures
Name Time Method Change from baseline of psychological flexibility at immediately after the 4-week treatments Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment (All these time points are consistent with the description) 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. AAQII has been cross-culturally adapted and validated among local adolescents and has demonstrated satisfactory internal consistency and test-retest reliability.
- Secondary Outcome Measures
Name Time Method Overall perceived changes in symptom severity, treatment response and the efficacy of treatment Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-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.
Change of LBP-related disability Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment 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.
Change of health-related quality of life Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment The Chinese version of EuroQol-5 Dimensions-levels (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.
Change of depression, anxiety, and stress Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment 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.
Change of LBP intensity Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment 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.
Trial Locations
- Locations (1)
Arnold YL Wong
🇭🇰Hong Kong, None Selected, Hong Kong