Cognitive Behavioral Therapy for Acid Reflux

Recruiting at 2 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

250 Participants Needed

Trial Summary

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 data supports the effectiveness of Cognitive Behavioral Therapy for Acid Reflux?

Cognitive Behavioral Therapy (CBT) has been shown to be effective for conditions like anxiety and depression by helping people change unhelpful thoughts and behaviors. While there is no direct evidence for acid reflux, the techniques used in CBT, such as mindfulness and acceptance strategies, have been successfully integrated into treatments for other conditions, suggesting potential benefits. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy (CBT) safe for humans?

Cognitive Behavioral Therapy (CBT) and its variations, like Dialectical Behavior Therapy (DBT) and Acceptance and Commitment Therapy (ACT), are generally considered safe for humans. They have been used to treat various conditions, including anxiety, depression, and borderline personality disorder, with safety measures in place to manage risks, especially in DBT for life-threatening behaviors. ^{6 7 8 9 10}

How does Cognitive Behavioral Therapy differ from other treatments for acid reflux?

Cognitive Behavioral Therapy (CBT) for acid reflux is unique because it focuses on psychological interventions to manage symptoms, unlike traditional treatments that primarily involve medications or surgery. CBT aims to change thought patterns and behaviors that may contribute to symptom perception, offering a non-drug approach for patients who may not respond well to standard medical treatments. ^{11 12 13 14 15}

What is the purpose of this trial?

This trial tests a new therapy called eCBT+ for patients with GERD who don't respond well to usual treatments. The therapy helps reduce stress and focus on symptoms by changing how patients think and behave. The goal is to see if this approach can improve their quality of life.

Research Team

John E Pandolfino, MD

Principal Investigator

Northwestern University

Tifffany Taft, PsyD

Principal Investigator

Northwestern University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Integrating mindfulness meditation with cognitive and behavioural therapies: the challenge of combining acceptance- and change-based strategies. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Long-term follow-up of a randomized controlled trial comparing acceptance and commitment therapy and standard cognitive behavior therapy for anxiety and depression. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Patient Characteristics and Patient Behavior as Predictors of Outcome in Cognitive Therapy and Exposure Therapy for Hypochondriasis. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Basic Strategies of Cognitive Behavioral Therapy. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Evidence-based treatment and cognitive-affective-relational-behavior-therapy. [2019]

6. United States 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. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Risk management in dialectical behavior therapy: Treating life-threatening behaviors as problems to be solved. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy for clients with binge-eating disorder or bulimia nervosa and borderline personality disorder. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

The Contribution of Psychological Inflexibility and Metacognitive Processes to Emotional Distress. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Management of Gastroesophageal Reflux Disease. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Refractory GERD, beyond proton pump inhibitors. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Optimal management of severe symptomatic gastroesophageal reflux disease. [2021]

14. Australia pubmed.ncbi.nlm.nih.gov

Therapeutic options for refractory gastroesophageal reflux disease. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

Endoscopic anti-reflux therapy for gastroesophageal reflux disease. [2023]