Trial reportEuropean journal of pain (London, England)2017
Applying causal mediation methods to clinical trial data: What can we learn about why our interventions (don't) work?
Trial report in European journal of pain (London, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prevention of Injuries Among Nurses and Nursing Aides Using Eastern Principles Acceptance and Commitment Therapy: Clinical Trial and Dissemination Research
Adolescent Surgery Roadmap Feasibility and Acceptability Study
Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 56 citations in OpenAlex.
- Behaviour change techniques used in lifestyle interventions that aim to reduce cancer-related fatigue in cancer survivors: a systematic review.The international journal of behavioral nutrition and physical activity · 2023Pooled it
- Toward a mechanistic understanding of LGBTQ-affirmative cognitive-behavioral therapy: Testing treatment mediators in a randomized controlled trial with young gay and bisexual men.Behaviour research and therapy · 2026Trial
- Yoga-based lifestyle intervention for healthy ageing in older adults: a two-armed, waitlist randomized controlled trial with multiple primary outcomes.GeroScience · 2024Trial
- Statins Do Not Significantly Affect Oxidative Nitrosative Stress Biomarkers in the PREVENT Randomized Clinical Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024Trial
- Trial
- Mediators of Effects on Physical Activity and Sedentary Time in an Activity Tracker and Behavior Change Intervention for Adolescents: Secondary Analysis of a Cluster Randomized Controlled Trial.JMIR mHealth and uHealth · 2022Trial
- Do Physical Therapy and Yoga Improve Pain and Disability through Psychological Mechanisms? A Causal Mediation Analysis of Adults with Chronic Low Back Pain.The Journal of orthopaedic and sports physical therapy · 2022Trial
- A Web-Based and In-Person Risk Reframing Intervention to Influence Mothers' Tolerance for, and Parenting Practices Associated With, Children's Outdoor Risky Play: Randomized Controlled Trial.Journal of medical Internet research · 2021Trial
- Improved Child Mental Health Following Brief Relationship Enhancement and Co-Parenting Interventions During the Transition to Parenthood.International journal of environmental research and public health · 2020Trial
- Mechanisms for reducing low back pain: a mediation analysis of a multifaceted intervention in workers in elderly care.International archives of occupational and environmental health · 2019Trial
- Identification of Indirect Effects in a Cognitive Patient Education (COPE) Intervention for Low Back Pain.Physical therapy · 2017Trial
- Ozone exposure is positively correlated with the occurrence of Kawasaki disease in Chinese children.Pediatric research · 2026Article
- Article
- A six-week group program of emotion focused family therapy for parents of children with mental health challenges: protocol for a randomized controlled trial.BMC psychiatry · 2025Article
- From ICU Syndromes to ICU Subphenotypes: Consensus Report and Recommendations for Developing Precision Medicine in the ICU.American journal of respiratory and critical care medicine · 2024Review
- Article
- A cognitive-behavioral suicide prevention treatment for adults with schizophrenia spectrum disorders in community mental health: Preliminary findings of an open pilot study.Social work in mental health · 2023Article
- Breathing-Focused Yoga Intervention on Respiratory Decline in Chronically Pesticide-Exposed Farmers: A Randomized Controlled Trial.Frontiers in medicine · 2022Article
- Choosing what works for whom: towards a better use of mechanistic knowledge in clinical practice.Archives of physiotherapy · 2021Article
- Identifying neural signatures mediating behavioral symptoms and psychosis onset: High-dimensional whole brain functional mediation analysis.NeuroImage · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMany randomized controlled trials (RCTs) of psychosocial interventions for low back pain (LBP) have been found to have only small effects on disability outcomes. Investigations of the specific mechanisms that may lead to an improvement in outcome have therefore been called for.
methodsWe present an application of the causal inference approach to mediation analysis using the example of a cluster RCT in a primary care population with (sub)acute LBP randomized to either usual GP care (n = 171) or a minimal psychosocial intervention (n = 143). Mediation analysis explored the causal pathway between treatment allocation and disability at 3 months by considering pain catastrophizing, fear-avoidance beliefs, distress and receiving and following advice as potential mediators, all measured at 6 weeks. We have attempted to explain this approach to mediation analysis in a step-by-step manner to help clinical researchers apply this method more easily.
resultsIn unadjusted mediation analyses, fear-avoidance beliefs were identified as a mediator of treatment on disability, with an indirect effect of -0.30 (95% CI: -0.86, -0.03), although this relationship was found to be non-significant after adjusting for age, gender and baseline scores. This finding supports the trial authors' hypothesis that while fear-avoidance beliefs are important, this intervention may not have targeted them strongly enough to lead to change.
conclusionThe use of mediation analysis to identify what factors may be part of the causal pathway between intervention and outcome, regardless of whether the intervention was successful, can provide useful information and insight into how to improve future interventions. SIGNIFICANCE: This study presents a step-by-step approach to mediation analysis using the causal inference framework to investigate why a psychosocial intervention for LBP was unsuccessful. Fear-avoidance beliefs were found to mediate the relationship between treatment and disability, although not when controlling for baseline scores.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.