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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

Primary Purpose

Chronic Low-back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Acceptance and commitment therapy (ACT)
back exercise
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Low-back Pain focused on measuring Chronic Low-back Pain (CLBP), Acceptance and commitment therapy (ACT), psychological flexibility

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Older people with ACT intervention

Older people without ACT intervention

Arm Description

4 week ACT plus back exercise group

4-week back exercise control group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 30, 2023
Last Updated
June 16, 2023
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT05919446
Brief Title
The Feasibility, Potential Efficacy, and Experiences of Using a Group-based Acceptance and Commitment Therapy Among Older People With Chronic Low Back Pain
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
July 30, 2025 (Anticipated)
Study Completion Date
July 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Chronic Low-back Pain (CLBP), Acceptance and commitment therapy (ACT), psychological flexibility

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double-blinded (participants and statistician)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Older people with ACT intervention
Arm Type
Experimental
Arm Description
4 week ACT plus back exercise group
Arm Title
Older people without ACT intervention
Arm Type
Other
Arm Description
4-week back exercise control group
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and commitment therapy (ACT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
back exercise
Intervention Description
The control group will undergo 1 hour of back exercise class, while the control group will be led by a trained exercise trainer.
Primary Outcome Measure Information:
Title
Change from baseline of psychological flexibility at immediately after the 4-week treatments
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. AAQ-II has been cross-culturally adapted and validated among local adolescents and has demonstrated satisfactory internal consistency and test-retest reliability.
Time Frame
Baseline and at immediately after the 4-week treatments
Secondary Outcome Measure Information:
Title
Change of LBP intensity
Description
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.
Time Frame
Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Title
Change of LBP-related disability
Description
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.
Time Frame
Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Title
Change of health-related quality of life
Description
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.
Time Frame
Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Title
Change of depression, anxiety, and stress
Description
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.
Time Frame
Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Title
Overall perceived changes in symptom severity, treatment response and the efficacy of treatment
Description
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.
Time Frame
Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Title
Change from baseline of psychological flexibility at 3-month post-treatment
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. AAQ-II has been cross-culturally adapted and validated among local adolescents and has demonstrated satisfactory internal consistency and test-retest reliability.
Time Frame
Baseline and at 3-month post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnold Wong, PhD
Phone
27666741
Email
arnold.wong@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnold Wong, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

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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

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