Delivering an Optimised Behavioural Intervention (OBI) to people with low back pain with high psychological risk; results and lessons learnt from a feasibility randomised controlled trial of Contextual Cognitive Behavioural Therapy (CCBT) vs. physiotherapy
Open accessAbstract
BACKGROUND: Low Back Pain (LBP) remains a common and costly problem. Psychological obstacles to recovery have been identified, but psychological and behavioural interventions have produced only moderate improvements. Reviews of trials have suggested that the interventions lack clear theoretical basis, are often compromised by low dose, lack of fidelity, and delivery by non-experts. In addition, interventions do not directly target known risk mechanisms. We identified a theory driven intervention (Contexual Cognitive Behavioural Therapy, CCBT) that directly targets an evidence-based risk mechanism (avoidance and ensured dose and delivery were optimised. This feasibility study was designed to test the credibility and acceptability of optimised CCBT against physiotherapy for avoidant LBP patients, and to test recruitment, delivery of the intervention and response rates prior to moving to a full definitive trial. METHODS: A randomised controlled feasibility trial with patients randomised to receive CCBT or physiotherapy. CCBT was delivered by trained supervised psychologists on a one to one basis and comprised up to 8 one-hour sessions. Physiotherapy comprised back to fitness group exercises with at least 60 % of content exercise-based. Patients were eligible to take part if they had back pain for more than 3 months, and scored above a threshold indicating fear avoidance, catastrophic beliefs and distress. RESULTS: 89 patients were recruited. Uptake rates were above those predicted. Scores for credibility and acceptability of the interventions met the set criteria. Response rates at three and six months fell short of the 75 % target. Problems associated with poor response rates were identified and successfully resolved, rates increased to 77 % at 3 months, and 68 % at 6 months. Independent ratings of treatment sessions indicated that CCBT was delivered to fidelity. Numbers were too small for formal analysis. Although average scores for acceptance were higher in the CCBT group than in the group attending physiotherapy (increase of 7.9 versus 5.1) and change in disability and pain from baseline to 6 months were greater in the CCBT group than in the physiotherapy group, these findings should be interpreted with caution. CONCLUSIONS: CCBT is a credible and acceptable intervention for LBP patients who exhibit psychological obstacles to recovery. TRIAL REGISTRATION: ISRCTN43733490 , registered 15/12/2010.
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In Pincus 2015, ACT compared to active control (AC) recorded that no adverse events were reported by participants.
“The first delivered ACT compared to AC and recorded that no AEs were reported by participants (Pincus 2015).”
From Psychological therapies for the management of chronic pain (excluding headache) in adults (2020) · cites this paper as Pincus 2015
The ‘Fit with other studies’ section says ACT formed the basis of the CCBT intervention, and the ‘Discussion’ identifies physiotherapy as the control treatment. The cited trial therefore supports the comparison, but our copy does not report that participants reported no adverse events; searches for adverse events and harms found no such result. Page numbers were not available in our copy. (LLM, conf=0.83)
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- Authors
- on behalf of the OBI Trial Management Team, Pincus, T., Anwar, S., McCracken, L. M., McGregor, A., Graham, L., Collinson, M., McBeth, J., Watson, P., Morley, S., Henderson, J., & Farrin, A. J.
- Affiliations
- University of London (GB)
- University of Leeds (GB)
- King's College London (GB)
- University of Leicester (GB)
- Corresponding author
- Pincus, Tamar
- ORCID
- Venue
- BMC Musculoskeletal Disorders
- Published
- 2015-06-16
- Volume
- 16
- Issue
- 1
- Pages
- 147-147
- ISSN
- 1471-2474 (ISSN-L)
- PMC
- PMC4468803
- OpenAlex
- W2124016273
- Cited by
- 49
- References
- 21
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 4 · 2023: 4 · 2022: 6 · 2021: 5 · 2020: 4 · 2019: 5 · 2018: 5 · 2017: 3 · 2016: 3 · 2015: 2
- FWCI
- 3.13
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- BMC Musculoskeletal Disorders (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- ePrints Soton (University of Southampton) (acceptedVersion)
- Keele Research Repository (Keele University) (submittedVersion, cc-by)
- Research Portal (King's College London) (submittedVersion)
- Funders
- Solent NHS Trust
- University College London
- University College London Hospitals NHS Foundation Trust
- Versus Arthritis (19401)
- Topics
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Treatment
- Keywords
- fear avoidance, psychological risk, physiotherapy, intervention optimization, acceptability, treatment response rate, intervention fidelity
- MeSH terms
- Adult, Affect, Disability Evaluation, England, Feasibility Studies, Humans, Health Knowledge, Attitudes, Practice, Male, Middle Aged, Pain Measurement, Quality of Life, Time Factors, Cognitive Behavioral Therapy, Treatment Outcome, Low Back Pain, Physical Therapy Modalities, Illness Behavior, Chronic Pain
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