P-061 - Psycho-Social Predictors of Treatment Effectiveness From Skills-Based VR-Delivered Therapy? Secondary Analysis of a Randomized Controlled Trial in Chronic Low Back Pain

Abstract Title: Psycho-Social Predictors of Treatment Effectiveness From Skills-Based VR-Delivered Therapy? Secondary Analysis of a Randomized Controlled Trial in Chronic Low Back Pain


Background: Chronic low back pain (cLBP) is the most prevalent chronic pain condition worldwide.1 Chronic pain experts recommend pain education and cognitive behavior therapy (CBT) as effective first-line treatments for cLBP. 2, 3, 4 The Centers for Disease Control (CDC) and Health and Human Services (HHS) 5, 6 concur, but also cite the need to improve patient access to effective treatments. CBT and other behavior interventions often require multiple sessions with a trained therapist. Thus access to care remains poor due to barriers such as few trained and available local therapists, health insurance limits, and burdens associated with travel and treatment time.7 There is an urgent need for effective, accessible, in-home, low-risk treatments that are available to people with cLBP.5, 6 Skills-Based virtual reality (VR)-delivered therapy, self-administered in-home may provide a solution. We recently completed a decentralized double-blinded randomized controlled trial that compared a 56-session Skills-Based VR-delivered program against an active ShamVR and showed clinically meaningful reductions in pain intensity and pain interference that were statistically larger than for Sham.8

Purpose/Objectives: While the Maddox et al8 results suggest that the Skills-Based VR program leads to clinically meaningful reductions in pain intensity and pain interference in the aggregate, clinicians must make patient-centric treatment choices on a daily basis and appreciate that unique characteristics may lead to better outcomes. Relevant factors may include patients’ perceptions about their pain, interoceptive awareness and locus of control. Pain catastrophizing, refering to an exaggerated negative orientation toward pain, can negatively affect treatment outcomes9. Similarly, interoceptive awareness, the perception of internal bodily sensations, has also been linked to chronic pain treatment effectiveness with self-regulation and trusting bodily senses enhancing therapeutic response10,11. Finally, locus of control, reflecting beliefs about the controllability of events, impacts pain experiences, with an internal locus of control leading to better treatment outcomes12. The purpose of this work is to understand the interplay between these psychosocial factors relative to comprehensive chronic pain management strategies.


Methods: A national sample of N=1093 individuals with self-reported non-malignant low back pain > 3 months duration and with average pain intensity and pain interference > 4/10 were enrolled and randomized 1:1 to one of two 56-session VR-delivered programs: (1) Skills-Based VR (immersive pain relief skills); or (2) Sham VR (two-dimensional (2D) nature content). The fixed-sequence Skills-Based VR-delivered program is an immersive multi-modal pain self-management program that incorporates evidence-based principles of CBT, mindfulness, and pain neuroscience education. Consistent with VR-CORE trial guidelines, we selected an active control using non-immersive 2D content within a VR headset as the most rigorous VR placebo.13 Self-reported data were collected pre-treatment, and immediately following treatment. Relevant validated instruments are the Brief Pain Inventory (BPI; quantifying pain intensity and pain interference), Concerns About Pain (CAP; quantifying pain catastrophizing), Multidimensional Health Locus of Control (MHLC; quantifying internal and external locus of control), and Multidimensional Assessment of Interoceptive Awareness (MAIA; quantifying 5 core aspects of interoceptive awareness). Two backward linear regressions were conducted. One included baseline CAP, MHLC and MAIA as predictors of pain intensity reduction. The second included baseline CAP, MHLC and MAIA as predictors of pain interference reduction.


Results: Predicting Pain Intensity Reduction: The baseline CAP, MAIA Trusting Bodily Senses, MHLC External Locus of Control: Doctors, MAIA Awareness of Mind-Body Integration: Self-Regulation, and MHLC Internal Locus of Control were all significant predictors of the RelieVRx group reduction in pain intensity from baseline to end-of-treatment [F(5, 452) = 6.21, p < .0001], with an adjusted R2 of .054. We focus on the three strongest predictors. Baseline CAP was the strongest predictor of pain intensity reduction (Standardized β = .173) with greater levels of pain catastrophizing associated with larger reductions in pain intensity (F = 13.13, p < .0001). Baseline MAIA Trusting Bodily Senses was the second strongest predictor (Standardized β = .132) with increased trust in one’s bodily senses associated with larger reductions in pain intensity (F = 5.32, p = .012). Baseline MHLC External Locus of Control: Doctors was the third strongest predictor (Standardized β = -.116) with increased belief that one's health is determined by doctors or health professionals (increased external locus of control) associated with smaller reductions in pain intensity (F = 5.50, p = .019). Predicting Pain Interference Reduction: The Baseline CAP, MAIA Trusting Bodily Senses, MAIA Awareness of Mind-Body Integration: Emotional Awareness, and MHLC External Locus of Control: Doctors were all significant predictors of the reduction in pain interference from baseline to end-of-treatment [F(4, 453) = 9.10, p < .0001], with an adjusted R2 of .066. We focus on the three strongest predictors. Baseline CAP was the strongest predictor of pain interference reduction (Standardized β = .190) with greater levels of pain catastrophizing associated with larger reductions in pain interference (F = 16.02, p < .0001). Baseline MAIA Trusting Bodily Senses was the second strongest predictor (Standardized β = .129) with increased trust in one’s bodily senses associated with larger reductions in pain interference (F = 6.02, p = .015). Baseline MAIA Awareness of Mind-Body Integration: Emotional Awareness was the third strongest predictor (Standardized β =.128) with an increased awareness of the connection between body sensations and emotional states associated with larger reductions in pain interference (F = 7.22, p = .007).

Conclusions/Implications for future research and/or clinical care: The most interesting finding is that catastrophizing is the strongest predictor for reductions in both pain intensity and interference, contrary to recognition it can reduce treatment effectiveness of cognitive and behavioral interventions 14. While there is still much to be learned about VR-delivered therapies, the skills-based immersive program trains skills and habits through emotional and behavioral learning centers in the brain which may dampen the negative effects of the cognitive process of catastrophizing 15. Importantly, levels of catastrophizing are likely to be easily recognized in clinician-patient interactions without reliance on validated measurement scales. Interoceptive awareness around trusting bodily senses is lower in chronic pain states 16 so it is unsurprising that higher levels are predictive of better outcomes. Similarly, internal locus of control indicating feelings of self-efficacy are predictive of better pain outcomes 17 as seen in this study. Interoceptive awareness and locus of control may not be clinically obvious.


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