Cognitive Behavioral Therapy for Gastroparesis Symptoms

Central and Peripheral Effects of Cognitive Behavioral Therapy on Brain-Gut Axis Signaling in Gastroparetic Patients

This study is testing whether Cognitive Behavioral Therapy can help people with gastroparesis feel better by reducing symptoms like nausea and pain, while also looking at its effects on anxiety and depression.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT03531450 on ClinicalTrials.gov

What this trial studies

This pilot study at Massachusetts General Hospital investigates the effects of Cognitive Behavioral Therapy (CBT) on patients with gastroparesis. It aims to assess how CBT can alleviate symptoms such as nausea, vomiting, and pain, while also examining its impact on related conditions like depression and anxiety. Participants will undergo various assessments, including brain MRI and gastric emptying tests, before and after the intervention to evaluate changes in their condition. The study seeks to understand the brain-gut axis signaling and how CBT may improve treatment strategies for gastroparesis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with idiopathic gastroparesis symptoms lasting at least 12 weeks.

Not a fit: Patients with non-idiopathic causes of gastroparesis or those who have previously received CBT for chronic illness may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a non-pharmacological treatment option that significantly improves the quality of life for patients with gastroparesis.

How similar studies have performed: Previous studies have shown that CBT can effectively reduce pain and improve mental health outcomes in chronic pain patients, suggesting potential success for this approach in gastroparesis.

Eligibility criteria

Inclusion Criteria:

1. Male and female patients aged 18 - 65 years old (inclusive)
2. Symptoms of gastroparesis of at least 12 weeks duration (do not have to be continuous) with varying degrees of nausea, vomiting, early satiety, and/or post-prandial fullness
3. An idiopathic etiology
4. GES of solids using 4 hours Egg Beaters® protocol within the last 2 years with either:

   \- Abnormal gastric emptying rate defined as an abnormal 2 hour (\>60% retention) and/or 4 hour (\>10% retention) result based on a 4 hour scintigraphic low fat Egg Beaters® gastric emptying study.
5. Body mass index (BMI) ≥ 17.5 kg/m2
6. Have not previously received CBT for coping with chronic illness
7. Have access to a computer with internet access
8. Speak, write, and understand English
9. On stable doses of any medication for 30 days prior to entering the study (exceptions are psychotropic, opioids, and/or illicit drugs) and agrees not to change medications or dosages during the study period.

Exclusion Criteria:

1. Inability to comply with or complete GES test (including allergy to eggs)
2. Use of narcotic analgesics greater than three days per week
3. Presence of other conditions that could explain the patient's symptoms:

   * Pyloric or intestinal obstruction as determined by endoscopy, upper GI series or abdominal CT scan
   * Active inflammatory bowel disease
   * Known eosinophilic gastroenteritis or eosinophilic esophagitis
   * Primary neurological conditions that could cause nausea and/or vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
   * Acute liver failure
   * Acute renal failure
   * Chronic renal failure (serum creatinine \>3 mg/dL) and/or on hemodialysis or peritoneal dialysis
   * Prior gastric surgery to restore function or relieve GI symptoms including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, or gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy. Note: patients with prior (Nissen, Dor, or Toupet) fundoplication will be eligible for enrollment.
   * Subject has current evidence of duodenal ulcer, gastric ulcer, diverticulitis, active GERD or infectious gastroenteritis.
   * Any acute gastrointestinal process.
   * Any other plausible structural or metabolic cause
   * Any condition, which in the opinion of the investigator, would interfere with study requirements
4. Inability to provide informed consent
5. BMI more than 32 and/or weight \> 235 lbs. (limits of the MRI table)
6. Enteral or parenteral feeding
7. Epilepsy or a prior history of seizures
8. Pregnancy or nursing
9. Psychotherapy initiated in the last 8 weeks
10. Contraindications for MRI: High magnetic fields may pose a serious health hazard to subjects with implanted ferromagnetic objects. Every subject in this study will be carefully screened before entering the high magnetic field shielded room to collect a precise outline of the subject's medical history. Subjects with the following characteristics/disease will not be eligible to participate in the study:

    * History of Head Trauma
    * Any metallic implants (e.g. braces or permanent retainers)
    * Tattoos with metallic ink above the nipple line
    * Surgical Aneurysm Clips
    * Cardiac Pacemaker
    * Prosthetic Heart Valve
    * Neurostimulator
    * Implanted pumps
    * Cochlear Implants
    * Metal rods, Plates
    * Screws
    * Recent Previous Surgery
    * IUD
    * Hearing Aid
    * Dentures (which might create NMR artifacts)
    * Metal Injury to eyes
    * Pregnancy or plans to become pregnant
    * Breast Feeding
    * Meniere's Disease
    * Transdermal (skin) patches such as NicoDerm (nicotine for tobacco dependence), Transderm Scop, or Ortho Evra (birth control)
    * Claustrophobia
    * Suicidal ideation as indicated from the HADS

All concomitant medications taken during the study will be recorded in the case report form, along with dosage information and start and stop dates. Patients requiring excluded drugs will be discontinued from the study.

Where this trial is running

Boston, Massachusetts

• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Braden Kuo, MD — Massachusetts General Hospital
• Study coordinator: Rebecca Karlson

Conditions Gastroparesis