Cognitive Behavioral Therapy for Acid Reflux

Enrolling by invitation at 3 trial locations

Overseen By Christine E Nelson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: H2 blockers, Antacids

Disqualifiers: Heart disease, Barrett's esophagus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Cognitive Behavioral Therapy (CBT) can help people with GERD, a condition causing symptoms like heartburn and chest pain, by changing their reactions to these symptoms. Participants will receive either CBT sessions focused on managing stress and anxiety or standard lifestyle coaching. The goal is to determine if CBT improves symptom management more effectively than typical lifestyle advice. Individuals who have experienced GERD symptoms without relief from standard treatments might be suitable candidates for this study. As an unphased trial, this study offers participants a unique opportunity to explore innovative treatment options that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications that affect gastrointestinal symptoms, like H2 blockers, antacids, and some others. However, you can continue taking antidepressants if they are at a stable dose.

What prior data suggests that Cognitive Behavioral Therapy is safe for GERD patients?

Research has shown that Cognitive Behavioral Therapy (CBT) is generally safe for most people. For many years, CBT has helped individuals with mental health issues by teaching them to transform negative thoughts and behaviors into positive ones. No serious risks are associated with CBT itself.

Studies have found that CBT can help manage stress and anxiety without harmful side effects. Since it involves talking and exercises instead of medication, it is usually well-tolerated. Reports of severe negative effects from CBT sessions are absent, making it a safe option for managing conditions like acid reflux. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for acid reflux, like proton pump inhibitors (PPIs) and lifestyle changes, focus on reducing stomach acid or avoiding triggers. But Cognitive Behavioral Therapy (CBT) offers a unique approach by addressing the psychological aspects of the condition. Researchers are excited about this treatment because it aims to improve cognitive and emotional responses related to reflux, reduce anxiety, and enhance coping strategies. Through techniques like diaphragmatic breathing to increase heart rate variability, CBT could potentially provide relief by targeting the brain-gut connection rather than just the stomach. This innovative method could pave the way for more holistic management of acid reflux symptoms.

What evidence suggests that Cognitive Behavioral Therapy might be an effective treatment for GERD?

Research has shown that Cognitive Behavioral Therapy (CBT), which participants in this trial may receive, might help people with GERD, also known as acid reflux. Studies have found that CBT can reduce excessive alertness and anxiety, common in GERD patients. CBT also affects the part of the nervous system that controls functions like heart rate, potentially easing symptoms. In other conditions, CBT has successfully changed negative thoughts and behaviors. This suggests that CBT could help GERD patients by addressing stress that can worsen symptoms. Meanwhile, another group in this trial will receive Sham-SOC Lifestyle Coaching, focusing on lifestyle guidance without CBT principles. ^{1 4 6 7 8}

Who Is on the Research Team?

John E Pandolfino, MD

Principal Investigator

Northwestern University

Tifffany Taft, PsyD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can have procedures to check my digestive health.

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

I experience heartburn, regurgitation, and chest pain not related to the heart.

Exclusion Criteria

Pregnant patients

My other illnesses are stable, and I am not currently undergoing any major medical investigations.

I have symptoms of heart disease or non-cardiac chest pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 sessions of 45 minutes each of either eCBT+ or sham-SOC Lifestyle Coaching delivered via telehealth

9 weeks

6 visits (virtual)

Follow-up

Participants are monitored for changes in symptoms, quality of life, and autonomic arousal after treatment

16 weeks

1 visit (in-person) at week 25

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy
• Sham-SOC Lifestyle Coaching

Trial Overview

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.

How Is the Trial Designed?

Group I: eCBT+ Experimental Treatment 1 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 Coaching Placebo Group 1 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.

Cognitive Behavioral Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in United States as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)
• Substance use disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Vanderbilt University School of Medicine

Collaborator

Trials

16

Recruited

13,900+

Published Research Related to This Trial

A study involving 688 undergraduates found that cognitive behavioral therapy (CBT) that incorporates safety behaviors is significantly more acceptable to participants than traditional CBT that discourages such behaviors.

Cognitively based CBT was preferred over extinction-based CBT, and factors like previous treatment and higher anxiety levels were linked to lower acceptability ratings, highlighting the importance of tailoring CBT approaches to enhance their acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Further Support for the Acceptability-Enhancing Roles of Safety Behavior and a Cognitive Rationale in Cognitive Behavioral Therapy for Anxiety Disorders. Levy, HC., Senn, JM., Radomsky, AS.[2020]

Cognitive Behavioral Therapy (CBT) employs active and collaborative strategies, such as cognitive restructuring, to help patients identify and change unhelpful thoughts that contribute to emotional distress.

CBT also includes techniques like behavioral activation to encourage engagement in pleasurable activities, exposure therapy to reduce fear responses, and problem-solving to systematically tackle life challenges, making it a comprehensive approach for treating various mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basic Strategies of Cognitive Behavioral Therapy. Wenzel, A.[2018]

Dialectical behavior therapy (DBT) is an effective treatment for individuals with borderline personality disorder, specifically targeting life-threatening behaviors like suicide attempts and self-injury.

DBT incorporates various strategies for risk management and safety planning, such as diary cards and phone coaching, to help clients commit to reducing harmful behaviors throughout their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk management in dialectical behavior therapy: Treating life-threatening behaviors as problems to be solved. Alba, MC., Bailey, KT., Coniglio, KA., et al.[2022]

Dialectical behavior therapy (DBT) is an effective, evidence-based treatment specifically designed for borderline personality disorder (BPD), particularly benefiting parasuicidal women, but also showing promise for those with substance use disorders and binge-eating disorder.

DBT incorporates unique elements such as a focus on emotions, a dialectical philosophy, and mindfulness techniques, which differentiate it from other cognitive-behavioral therapies and are essential for its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy: current indications and unique elements. Chapman, AL.[2021]

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