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Targeting Hypervigilance and Autonomic Arousal: the Psycho-physiologic Model of Gastroesophageal Reflux Disease (GERD)

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later May 31, 2026 → May 31, 2028
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Record History

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  1. Notable Primary completion pushed from May 31, 2026 to May 31, 2028
    • Study completion pushed from Nov 30, 2026 to Nov 30, 2028
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 2 of 2 entries
  2. Minor 3 versions Re-verified since Apr 10, 2023, no change to tracked fieldsv3-v5
  3. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Jun 2022 to Apr 19, 2022
    • Site contacts updated at 2 of 2 sites
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
GERD affects roughly 20% of the U.S. population and the direct and indirect costs of GERD are substantial, totaling close to 50 billion dollars per year. Evidence supports that a large proportion of this cost and poor clinical outcomes in GERD are related to poor healthcare decisions by both the physician and the patient. The problem of inappropriate GERD management stems from three main issues. First, the disease is heterogeneous and requires treatment informed by a precision model. Second, the current paradigm largely ignores the important brain-gut interactions that drive symptoms and healthcare utilization. Third, there is a paucity of well-performed comparative effectiveness trials focused on assessing treatments beyond acid suppression. We will use physiomarkers defined during the previous funding cycle to phenotype the patients and use cognitive behavioral interventions to modulate hypervigilance to test the Psycho-Physiologic Model of GERD. Cognitive Behavioral Therapy (CBT) is able to improve hypervigilance and symptom specific autonomic arousal and thus, we will test our theory that CBT can improve outcomes in GERD by targeting these two important psychologic stressors. We will also continue our focus on the interplay of psychology and physiology by determining whether increased mucosal permeability is associated with reflux perception and whether this is modified by hypervigilance and autonomic disruption.
Trial Details
NCT Number NCT04960566
Lead Sponsor Northwestern University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Washington University School of Medicine, University of California, San Diego, Vanderbilt University School of Medicine
Conditions
(from sponsor)
Gastroesophageal Reflux
Related terms Gastroesophageal Reflux
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov