An Adaptive Intervention to Improve Pain Outcomes Following Cognitive Behavioral Therapy for Insomnia in Patients with Comorbid Chronic Low Back Pain and Insomnia - Chronic low back pain (CLPB) affects over a half billion people worldwide and is the leading cause of disability. Sleep disturbance prospectively predicts increased pain, which has led to enthusiasm over the potential for cognitive behavioral therapy for insomnia (CBTi)—the gold standard insomnia treatment—to improve both sleep and pain outcomes in patients with comorbid chronic pain and insomnia. However, the majority of patients do not experience a clinically meaningful pain response (defined as at least 30% reduction in pain) following CBTi. Factors predicting who will or will not be a pain responder to CBTi are poorly understood, limiting the ability to appropriately plan treatments in this population. Existing interventions have not optimally addressed the mechanisms of sleep and pain. Therefore, the proposed study will investigate if adding a mechanistically informed adjunct intervention to CBTi improves pain outcomes among patients with comorbid CLBP/insomnia whose pain does not respond to CBTi alone. Our preliminary data from both experimental and naturalistic studies demonstrate that positive affect is a key mechanism linking sleep disturbance and pain. Positive affect both directly reduces pain and attenuates the impact of sleep disturbance on clinical pain. This suggests positive affect may be an innovative adjunctive treatment target in patients with comorbid CLBP/insomnia whose pain do not respond to CBTi. In the present study, we will enroll patients with comorbid CLBP/insomnia in CBTi, using an established and validated internet-delivered CBTi platform which has repeatedly been shown to yield similar improvements in insomnia as face-to-face CBTi. All patients will initially receive CBTi (N=300). At baseline, patients will complete questionnaires to evaluate phenotypic characteristics of sleep, pain, and affective function. After completing CBTi (at 9 weeks), pain responders (≥30% reduction in pain severity) will be discharged from treatment, while pain non-responders (< 30% reduction in pain severity) will be randomized to receive either a telehealth-delivered positive affect enhancing intervention (Savoring Meditation) or an attention control (Pain Education) over 2 weeks. The primary outcome will be pain severity, and outcomes will be tracked to 12 month follow-up for analyses of effect durability. Aim 1 is to evaluate the effect of adding Savoring Meditation as an adjunct to CBTi on pain severity for pain non-responders. Aim 2 is to investigate patient-level predictors of pain response to CBTi and Savoring Meditation. Aim 3 is exploratory, and will examine whether change in insomnia severity is a moderator of pain response to Savoring Meditation. This project offers substantial promise for impact offering a mechanistically informed intervention to patients with CLBP and insomnia who need it most: those who fail to experience pain reduction to CBTi intervention. The proposed study also offers a significant opportunity for scaling by utilizing highly accessible digital and telehealth interventions that target both sleep and positive affect as a means of reducing pain.
