Feasibility, Effectiveness, and Patient Experience of Online Acceptance and Commitment Therapy Plus Exercises for Older People With Chronic Low Back Pain

NCT06576414 | Recruiting

• 1 other identifier: HSEARS20240503001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Low-back Pain

Keywords

Chronic Low-back Pain (CLBP); Acceptance and commitment therapy (ACT); Psychological flexibility; Online intervention

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. AAQII has been cross-culturally adapted and validated among local adolescents and has demonstrated satisfactory internal consistency and test-retest reliability.

  Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment (All these time points are consistent with the description)

Secondary Outcomes (5)

• Change of LBP intensity

  Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment

• Change of LBP-related disability

  Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment

• Change of health-related quality of life

  Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment

• Change of depression, anxiety, and stress

  Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment

• 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

Study Arms (2)

Older people with online ACT intervention

EXPERIMENTAL

4 week ACT plus back exercise group

Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: back exercise

Older people without ACT intervention

ACTIVE COMPARATOR

4-week back exercise control group

Behavioral: back exercise; Behavioral: back care education

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

the first hour of ACT intervention followed by 1 hour of back exercise class, which led by a trained ACT counsellor and a trained exercise trainer

Older people with online ACT intervention

back exercise BEHAVIORAL

1 hour of back exercise class led by a trained exercise trainer

Older people with online ACT intervention; Older people without ACT intervention

back care education BEHAVIORAL

1 hour long interactive lesson to participants about LBP-related pathology, disability, psychology, and pain management skills.

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)

Arnold YL Wong

Hong Kong, None Selected, Hong Kong

RECRUITING

MeSH Terms

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Arnold YL Wong

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 13, 2024
• First Posted: August 28, 2024
• Study Start: July 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

HK (1)