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Cognitive Behavioral Therapy for Acid Reflux

N/A

Waitlist Available

Led By John E Pandolfino, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to undergo endoscopy, ambulatory reflux monitoring, and manometry

Aged 18-80 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 25

Awards & highlights

Study Summary

This trial will test whether Cognitive Behavioral Therapy (CBT) can improve outcomes in Gastroesophageal Reflux Disease (GERD) by targeting two important psychologic stressors.

Who is the study for?

This trial is for adults aged 18-80 with GERD symptoms who haven't improved after acid blocker therapy. They must be fluent in English, able to undergo specific digestive system tests, and interested in behavioral treatment. Excluded are those with severe esophagitis, certain esophageal conditions or surgeries, unstable illnesses, drug/alcohol abuse history, cognitive impairments, pregnancy, or taking medications affecting GI symptoms.Check my eligibility

What is being tested?

The study examines if Cognitive Behavioral Therapy (CBT) can improve GERD by reducing hypervigilance and autonomic arousal—body's stress responses. It compares CBT's effectiveness against a sham intervention that mimics standard lifestyle coaching but doesn't address these psychological factors.See study design

What are the potential side effects?

Since the interventions involve therapy and coaching rather than medication or invasive procedures, side effects may include discomfort from discussing personal issues during sessions or potential frustration if no improvement in GERD symptoms is perceived.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can have procedures to check my digestive health.

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I am between 18 and 80 years old.

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I understand the information given to me and can make decisions about my health care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 25

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 25

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 25 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

EHAS

Esophageal Permeability

GERD PROMIS

+4 more

Secondary outcome measures

Client Satisfaction Questionnaire - 8

Sessions completed

Side effects data

From 2021 Phase 4 trial • 12 Patients • NCT04135937

irritability

100%

80%

60%

40%

20%

Study treatment Arm

MESH

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: eCBT+Experimental Treatment1 Intervention

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).

Group II: Sham-SOC Lifestyle CoachingPlacebo Group1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

916,981 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,357 Previous Clinical Trials

4,314,936 Total Patients Enrolled

Washington University School of MedicineOTHER

1,931 Previous Clinical Trials

2,299,459 Total Patients Enrolled

Media Library

Cognitive Behavioral Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04960566 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could individuals aged under 45 potentially enrol in this experiment?

"This study has identified an age range of 18 to 80 as the eligibility criteria. Separately, there are 14 trials available for minors and 54 programs geared towards those aged 65 or above."

Answered by AI

What criteria must be fulfilled to participate in this experiment?

"The scope of this medical experiment is to include 250 adults, aged 18-80 years old, who suffer from gastroesophageal reflux. The following requirements must also be met: gender (females of childbearing age should use highly effective contraceptive methods), the ability to understand and provide informed consent orally in English language, presence of GERD symptoms (heartburn, regurgitation or non-cardiac chest pain) that weren't relieved by PPI therapy with a GERDQ score ≥6., endoscopic evaluation capability as well as ambulatory reflux monitoring and manometry eligibility; furthermore participants need to demonstrate interest towards"

Answered by AI

Are there any vacancies for those interested in participating in this medical trial?

"According to the latest clinicaltrials.gov update, this study is no longer enrolling patients as it was last modified on April 19th 2022. Nevertheless, there are currently 69 other trials recruiting participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

John Pandolfino 2022. "Targeting Hypervigilance and Autonomic Arousal: the Psycho-physiologic Model of Gastroesophageal Reflux Disease (GERD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04960566.

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