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

NCT05919446 | Recruiting

• 1 other identifier: HSEARS20230104002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Low-back Pain

Keywords

Chronic Low-back Pain (CLBP); Acceptance and commitment therapy (ACT); psychological flexibility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change of LBP intensity

  Baseline, immediately after the 4-week treatments, and at 3-month post-treatment

• Change of LBP-related disability

  Baseline, immediately after the 4-week treatments, and at 3-month post-treatment

• Change of health-related quality of life

  Baseline, immediately after the 4-week treatments, and at 3-month post-treatment

• Change of depression, anxiety, and stress

  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

  Baseline, immediately after the 4-week treatments, and at 3-month post-treatment

Study Arms (2)

Older people with ACT intervention

EXPERIMENTAL

4 week ACT plus back exercise group

Behavioral: Acceptance and commitment therapy (ACT); Behavioral: back exercise

Older people without ACT intervention

OTHER

4-week back exercise control group

Behavioral: back exercise

Interventions

Acceptance and commitment therapy (ACT) BEHAVIORAL

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.

Older people with ACT intervention

back exercise BEHAVIORAL

The control group will undergo 1 hour of back exercise class, while the control group will be led by a trained exercise trainer.

Older people with ACT intervention; Older people without ACT intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Arnold Wong, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnold Wong, PhD

CONTACT

27666741; arnold.wong@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blinded (participants and statistician)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 26, 2023
• Study Start: August 1, 2023
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

HK (1)