At-Home Morning Bright Light Treatment for Chronic Nociplastic Pain: Protocol for a Randomized Clinical Trial (Preprint)

<sec> <title>BACKGROUND</title> Fibromyalgia, the quintessential nociplastic pain condition, affects more than 20 million Americans and results in significant disability, lost productivity, and poor quality of life, with profound individual and societal cost. As pharmacological treatment approaches offer only modest benefits and result in a high rate of discontinuation due to adverse effects, nonpharmacological interventions such as physical therapy, exercise, and cognitive behavioral therapy are recommended. However, cost and access to these treatments can create barriers to care, and engagement can be problematic. Morning bright light treatment is a promising option for improving fibromyalgia symptoms, with early studies indicating clinically meaningful improvements in fibromyalgia symptoms. </sec> <sec> <title>OBJECTIVE</title> This study aims to prospectively examine the potential benefits and active elements of morning bright light treatment and sleep timing stabilization for individuals with fibromyalgia in the largest randomized controlled trial to date. </sec> <sec> <title>METHODS</title> We will recruit 390 adults who meet diagnostic criteria for fibromyalgia and report at least mild symptoms. Participants will be randomized to one of three groups: 4 weeks of morning bright light treatment (1 hour per day, using a commercially available Re-timer device), 4 weeks of sleep timing stabilization alone (a component of morning bright light treatment, some benefit anticipated), or 4 weeks of treatment as usual, with equivalent study contact. Patient-reported outcomes of function and pain will be assessed before and after treatment, with mood, sleep quality, and morningness-eveningness examined as potential mediators of treatment effects. Social determinants of health risk will be examined as a potential moderator influencing baseline symptoms, treatment engagement, and treatment response. </sec> <sec> <title>RESULTS</title> Data collection began in September 2024 and is projected to end in March 2029. </sec> <sec> <title>CONCLUSIONS</title> Morning bright light treatment is well-positioned to be an effective nonpharmacological treatment for fibromyalgia with minimal side effects. The study findings will provide important insights relevant to the development of morning bright light treatment as an accessible treatment for chronic nociplastic pain. </sec> <sec> <title>CLINICALTRIAL</title> ClinicalTrials.gov NCT06567886; https://clinicaltrials.gov/study/NCT06567886 </sec> <sec> <title>INTERNATIONAL REGISTERED REPORT</title> DERR1-10.2196/75060 </sec>