Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 27, 2025
Date Accepted: Aug 28, 2025
Date Submitted to PubMed: Aug 29, 2025
At Home Morning Bright Light Treatment for Chronic Nociplastic Pain: A Protocol for A Randomized Clinical Trial
ABSTRACT
Background:
Fibromyalgia, the quintessential nociplastic pain condition, affects >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, non-pharmacological 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.
Objective:
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 control trial to date.
Methods:
We will recruit 390 sociodemographically diverse 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 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.
Results:
N/A
Conclusions:
Morning bright light treatment is well-positioned to be an effective non-pharmacological 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. Clinical Trial: ClinicalTrials.gov NCT06567886
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