Gastroesophageal RefluxNCT04960566
Targeting Hypervigilance and Autonomic Arousal: the Psycho-physiologic Model of Gastroesophageal Reflux Disease (GERD)
A study testing Cognitive Behavioral Therapy in people with Gastroesophageal Reflux, run by Northwestern University at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Cognitive Behavioral Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Apr 2022to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects (females of childbearing potential should be on highly effective contraceptive methods)
- Aged 18-80 years old
- Mentally capable to provide informed consent
- Fluent in English
- Have symptoms of GERD (heartburn, regurgitation, and non-cardiac chest pain)
- Have failed an appropriate compliant trial of PPI therapy with a GERDQ score ≥6.
- Able to undergo endoscopy, ambulatory reflux monitoring, and manometry
- Be interested in behavioral interventions for ongoing symptoms.
Who cannot join
- Participation in a concurrent clinical trial or completed another trial within past 8 weeks.
- Active severe erosive esophagitis (Los Angeles Grade C or D), Long segment Barrett's esophagus (Zap score of 4)
- Prior gastrointestinal surgery of the esophagus and/or stomach
- Current signs or symptoms of heart disease. All patients with non-cardiac chest pain are required to have a cardiologist evaluation as standard of care work up in the evaluation of non-cardiac chest pain.
- Unstable medical illness with ongoing diagnostic work-up and treatment. Patients with well-controlled hypertension, diabetes and a remote history of ischemic heart disease that is deemed stable, as judged by the investigator can be included.
- History of drug addiction, drug abuse or alcoholism.
Show all 12Show fewer
- Current neurologic or cognitive impairment, which would preclude ability to obtain informed consent.
- Pregnant patients.
- Special vulnerable populations including children, prisoners, institutionalized individuals.
- Bleeding disorder or requirement of NSAID/aspirin during monitoring period.
- Drugs that affect gastrointestinal symptoms (H2 blockers, antacids, metoclopramide, domperidone, erythromycin, anticholinergics [bentyl, levsin, belladonna etc.]). Antidepressants can be continued at stable dose.
- Patients found to have achalasia, a spastic disorder, hypercontractile disorder or functional obstruction at the esophagogastric junction will be excluded
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
Washington University
St Louis, Missouri, 63110
About this study
Official title: Targeting Hypervigilance and Autonomic Arousal: the Psycho-physiologic Model of GERD
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.
Read the detailed 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.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Cognitive Behavioral Therapy, Sham-SOC Lifestyle Coaching
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyOther
The CBT intervention is based on the theoretical framework that under stress (reflux symptoms) a person makes a rapid cognitive appraisal of the potential threat (automatic thoughts), leading to both emotional and physical responses in the body, thereby reacting behaviorally (avoidance, increased HCU) in an attempt to mitigate unpleasantness. CBT is a collaborative, present-focused treatment that utilizes a skills-based approach with home practice exercises. CBT targets automatic thoughts and appraisals of threat via education, self-monitoring of stressors and symptoms, and strategies to reframe problematic thinking patterns to more adaptive ones. Resonance frequency breathing (RFB) is achieved when a person breathes at a pace, typically 4 to 6 breaths per minute, that engages the body's baroreflex to modulate arousal. Prior research demonstrates 4 to 6 weeks of RFB training is sufficient to significantly increase baseline HRV with enduring effects for up to 6 months.
Sham-SOC Lifestyle CoachingOther
Sham-SOC Lifestyle Coaching
| Study group | Role | What they receive |
|---|---|---|
| eCBT+ | Experimental | eCBT+ participants will be enrolled in 6, 45-minute sessions delivered via a secure video platform with a GI psychologist. To reinforce concepts reviewed in the sessions, participants will complete weekly home practice exercises. The targets are 1) improved maladaptive cognitive-affective processes associated with increased hypervigilance and symptom anxiety, 2) reduced behaviors associated with EHA including avoidance, increased medication/healthcare utilization and 3) reduced autonomic nervous system (ANS) arousal by increased HRV. Participants will learn to identify, question, and modify maladaptive thoughts, beliefs, and assumptions related to their symptoms (symptom anxiety). Systematic exposure to feared events are used to reduce maladaptive coping strategies (hypervigilance, PPI overuse, HCU). Specific, paced diaphragmatic breathing exercises (Resonance Frequency Breathing) designed to increase HRV are the last component (visceral hypersensitivity, reflux physiology). Receives: Other: Cognitive Behavioral Therapy |
| Sham-SOC Lifestyle Coaching | Sham comparator | Patients randomized to the SOC condition will receive lifestyle guidance recommended for patients with GERD over a period of 6, 45-minute sessions with the GI psychologist to maintain consistency of delivery between the two intervention arms. Topics include maintaining a healthy weight, identifying triggering food and drink, making healthy food choices, eating behaviors, smoking and/or alcohol use, and timing of meals. The SOC condition will be carefully designed to not include any principles of the eCBT+ condition rather be based solely on patient education and encouragement to practice lifestyle changes on their own. Receives: Other: Sham-SOC Lifestyle Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
GERD PROMIS
25-item measure of GERD symptom severity rated on Likert scale across 4 domains. Higher scores denote more GERD symptoms.
Measured: Week 9
GERD PROMIS
25-item measure of GERD symptom severity rated on Likert scale across 4 domains. Higher scores denote more GERD symptoms.
Measured: Week 25
NEQOL
14-item measure of HRQoL related to esophageal symptoms, rated on Likert scale. Higher scores denote greater negative impacts on HRQoL.
Measured: Week 9
NEQOL
14-item measure of HRQoL related to esophageal symptoms, rated on Likert scale. Higher scores denote greater negative impacts on HRQoL.
Measured: Week 25
EHAS
15-item measure of esophageal hypervigilance and symptom specific anxiety rated on Likert scale. Higher scores indicate more hypervigilance and anxiety.
Measured: Week 9
EHAS
15-item measure of esophageal hypervigilance and symptom specific anxiety rated on Likert scale. Higher scores indicate more hypervigilance and anxiety.
Measured: Week 25
Variation in Heart Rate Variability (HRV)
HRV will be measured using the time domains RMSSD and pNN50 calculated at each time point, as well as daily averages throughout treatment period.
Measured: from the date of randomization through the treatment period, up to 9 weeks
Heart Rate Variability (HRV)
HRV will be measured using the time domains RMSSD and pNN50 calculated at each time point, as well as daily averages throughout treatment period.
Measured: Week 9
Heart Rate Variability (HRV)
HRV will be measured using the time domains RMSSD and pNN50 calculated at each time point, as well as daily averages throughout treatment period.
Measured: Week 25
Esophageal Permeability
Permeability will be measured utilizing Mucosal Impedance (MI) measurement. Higher MI value indicates lower permeability
Measured: Week 9
Symptom Index
Symptom index is defined as the number of symptoms associated with reflux divided by the total number of symptoms as determined by pH-Impedance
Measured: Week 9
Secondary outcomes (2)
Client Satisfaction Questionnaire - 8
8-item measure of patient satisfaction with treatment rated on Likert scale. Higher scores indicate greater satisfaction with treatment.
Measured: Week 9
Sessions completed
Number of sessions of intervention (either arm) completed by each subject. Higher number of sessions indicate greater engagement with treatment
Measured: Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start19 Apr 2022
- Primary completion31 May 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, John Pandolfino, Northwestern University
- Investigators
- John E Pandolfino, MD, Principal investigator, Northwestern UniversityTifffany Taft, PsyD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960566
- Sponsor's protocol ID
- STU00214532
- Other IDs
- R01DK092217
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2021
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Hypervigilance and Autonomic Arousal: the Psycho-physiologic Model of GERD
- ClinicalTrials.gov ID
- NCT04960566
- Acronym / sponsor ID
- STU00214532
- Conditions
- Gastroesophageal Reflux
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- 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
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eCBT+ | Experimental | Other: Cognitive Behavioral TherapyeCBT+ participants will be enrolled in 6, 45-minute sessions delivered via a secure video platform with a GI psychologist. To reinforce concepts reviewed in the sessions, participants will complete weekly home practice exercises. The targets are 1) improved maladaptive cognitive-affective processes associated with increased hypervigilance and symptom anxiety, 2) reduced behaviors associated with EHA including avoidance, increased medication/healthcare utilization and 3) reduced autonomic nervous system (ANS) arousal by increased HRV. Participants will learn to identify, question, and modify maladaptive thoughts, beliefs, and assumptions related to their symptoms (symptom anxiety). Systematic exposure to feared events are used to reduce maladaptive coping strategies (hypervigilance, PPI overuse, HCU). Specific, paced diaphragmatic breathing exercises (Resonance Frequency Breathing) designed to increase HRV are the last component (visceral hypersensitivity, reflux physiology). |
| Sham-SOC Lifestyle Coaching | Sham comparator | Other: Sham-SOC Lifestyle CoachingPatients randomized to the SOC condition will receive lifestyle guidance recommended for patients with GERD over a period of 6, 45-minute sessions with the GI psychologist to maintain consistency of delivery between the two intervention arms. Topics include maintaining a healthy weight, identifying triggering food and drink, making healthy food choices, eating behaviors, smoking and/or alcohol use, and timing of meals. The SOC condition will be carefully designed to not include any principles of the eCBT+ condition rather be based solely on patient education and encouragement to practice lifestyle changes on their own. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects (females of childbearing potential should be on highly effective contraceptive methods)
- Aged 18-80 years old
- Mentally capable to provide informed consent
- Fluent in English
- Have symptoms of GERD (heartburn, regurgitation, and non-cardiac chest pain)
Key exclusion criteria (12 listed)
- Participation in a concurrent clinical trial or completed another trial within past 8 weeks.
- Active severe erosive esophagitis (Los Angeles Grade C or D), Long segment Barrett's esophagus (Zap score of 4)
- Prior gastrointestinal surgery of the esophagus and/or stomach
- Current signs or symptoms of heart disease. All patients with non-cardiac chest pain are required to have a cardiologist evaluation as standard of care work up in the evaluation of non-cardiac chest pain.
- Unstable medical illness with ongoing diagnostic work-up and treatment. Patients with well-controlled hypertension, diabetes and a remote history of ischemic heart disease that is deemed stable, as judged by the investigator can be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyThe CBT intervention is based on the theoretical framework that under stress (reflux symptoms) a person makes a rapid cognitive appraisal of the potential threat (automatic thoughts), leading to both emotional and physical responses in the body, thereby reacting behaviorally (avoidance, increased HCU) in an attempt to mitigate unpleasantness. CBT is a collaborative, present-focused treatment that utilizes a skills-based approach with home practice exercises. CBT targets automatic thoughts and appraisals of threat via education, self-monitoring of stressors and symptoms, and strategies to reframe problematic thinking patterns to more adaptive ones. Resonance frequency breathing (RFB) is achieved when a person breathes at a pace, typically 4 to 6 breaths per minute, that engages the body's baroreflex to modulate arousal. Prior research demonstrates 4 to 6 weeks of RFB training is sufficient to significantly increase baseline HRV with enduring effects for up to 6 months. | Other | eCBT+ |
| Sham-SOC Lifestyle CoachingSham-SOC Lifestyle Coaching | Other | Sham-SOC Lifestyle Coaching |
Primary outcome
GERD PROMIS
Time frame: Week 9
25-item measure of GERD symptom severity rated on Likert scale across 4 domains. Higher scores denote more GERD symptoms.
GERD PROMIS
Time frame: Week 25
25-item measure of GERD symptom severity rated on Likert scale across 4 domains. Higher scores denote more GERD symptoms.
NEQOL
Time frame: Week 9
14-item measure of HRQoL related to esophageal symptoms, rated on Likert scale. Higher scores denote greater negative impacts on HRQoL.
NEQOL
Time frame: Week 25
14-item measure of HRQoL related to esophageal symptoms, rated on Likert scale. Higher scores denote greater negative impacts on HRQoL.
EHAS
Time frame: Week 9
15-item measure of esophageal hypervigilance and symptom specific anxiety rated on Likert scale. Higher scores indicate more hypervigilance and anxiety.
EHAS
Time frame: Week 25
15-item measure of esophageal hypervigilance and symptom specific anxiety rated on Likert scale. Higher scores indicate more hypervigilance and anxiety.
Variation in Heart Rate Variability (HRV)
Time frame: from the date of randomization through the treatment period, up to 9 weeks
HRV will be measured using the time domains RMSSD and pNN50 calculated at each time point, as well as daily averages throughout treatment period.
Heart Rate Variability (HRV)
Time frame: Week 9
HRV will be measured using the time domains RMSSD and pNN50 calculated at each time point, as well as daily averages throughout treatment period.
Heart Rate Variability (HRV)
Time frame: Week 25
HRV will be measured using the time domains RMSSD and pNN50 calculated at each time point, as well as daily averages throughout treatment period.
Esophageal Permeability
Time frame: Week 9
Permeability will be measured utilizing Mucosal Impedance (MI) measurement. Higher MI value indicates lower permeability
Symptom Index
Time frame: Week 9
Symptom index is defined as the number of symptoms associated with reflux divided by the total number of symptoms as determined by pH-Impedance
2 secondary outcomes
Client Satisfaction Questionnaire - 8
Time frame: Week 9
Sessions completed
Time frame: Week 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John E Pandolfino, MD principal investigator
Northwestern University
Tifffany Taft, PsyD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Gastroesophageal Reflux, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GERD PROMIS (time frame: Week 9). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.