Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT04960566 |
Other study ID # |
STU00214532 |
Secondary ID |
R01DK092217 |
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 19, 2022 |
Est. completion date |
November 30, 2026 |
Study information
Verified date |
April 2023 |
Source |
Northwestern University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
OVERVIEW: In this randomized, sham-controlled phase II/III adaptive trial, we will randomize
250 subjects with symptoms of GERD to eCBT+ (esophageal Cognitive Behavioral Therapy) or
sham-SOC (Standard of Care) Lifestyle Coaching. Each subject will receive 6 sessions of 45
minutes each delivered by telehealth. The study will be conducted at two institutions:
Northwestern University and Washington University. The interventions will be delivered by GI
Health psychologists based at Northwestern University.
RANDOMIZATION AND BLINDING: Participants will be blinded as to the intervention they will
receive. Participants will be randomized in the following manner: In Aim 1, we will block on
site (NU or WashU) and randomize patients to eCBT+ or SOC within sites. In Aim 2, we will
block on site and whether patients have hypersensitivity. Patients within site and
hypersensitivity category (no vs. yes) will be randomized. Note that in randomizing in this
way, patients for Aim 3 who exhibit hypersensitivity will also be randomized within site. We
will allocate participants to one of 2 study arms in a blinded fashion: eCBT+ (esophageal
Cognitive Behavioral Therapy) or sham-SOC Lifestyle Coaching. Subjects will be de-briefed at
their week 25 visit.
STUDY PROCEDURES: Study procedures include mucosal impedance (MI) performed during standard
of care endoscopy, the use of questionnaires: GERD PROMIS (a measure of symptoms), EHAS
(Esophageal Hypervigilance and Anxiety Scale), NEQOL (Northwestern Esophageal Quality of
Life), GERDQ (a measure of symptom frequency), and patient satisfaction, as well as
measurement of heart rate variability both at the research site and via continuous FitBit
usage throughout the treatment period. For Aim 3, repeat endoscopy, mucosal impedance, and pH
impedance will be performed on a subset of patients 8 weeks after conclusion of intervention.
ENDPOINTS: Primary endpoints include change in symptoms and quality of life as measured by
GERDQ, GERD PROMIS and NEQOL questionnaires, change in hypervigilance and symptom-specific
anxiety as measured by EHAS and change in autonomic arousal as measured by HRV before and
after treatment with either intervention arm. Secondary endpoints include change in mucosal
impedance measurements and symptom index (as determined by pH-Impedance monitoring) before
and after treatment, as well as patient satisfaction with treatment and engagement with
treatment as defined by the number of sessions completed.
RATIONALE: We selected a parallel design study to explore the treatment effect of eCBT+
compared to a sham-SOC Lifestyle Coaching approach. Power and sample size considerations were
based on the primary aim of comparing questionnaire results and HRV measurements in the
proposed two-arm clinical trial.