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

NCT03531450 | Recruiting

• 1 other identifier: Partners Protocol ID Pending
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center pilot study to be conducted at Massachusetts General Hospital. The purpose of this study is to examine the non-pharmacological impact of Cognitive Behavioral Therapy (CBT) on gastroparesis symptoms and other clinical co-comorbidities such as pain, depression, anxiety, and catastrophizing. CBT trial patients will undergo careful phenotyping pre- and post- intervention with brain MRI, autonomic function test (AFT), gastric emptying scintigraphy (GES), and nutrient drink test (NDT) to determine the impact of CBT on these metrics in patients with gastroparesis. Characterization of these relationships or lack thereof can help guide future development of more targeted approaches and optimize treatment strategies for gastroparesis.

Conditions

Gastroparesis

Keywords

Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM)

  One of the primary endpoints will be change in gastroparesis symptom severity by the Gastroparesis Cardinal Symptom Inventory (GCSI). The GCSI is comprised of three subscales: post-prandial fullness/early satiety, nausea/vomiting, and bloating. A one-point decrease in the GCSI has been validated to indicate clinically significant improvement.

  Up to 12 weeks

Secondary Outcomes (22)

• Gastrointestinal symptom assessment via Short Form 36 Health Survey

  Up to 12 weeks

• Gastrointestinal symptom assessment via Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life

  Up to 12 weeks

• Gastrointestinal symptom assessment via Rome III Diagnostic Questionnaire for Adult Functional GI Disorders

  Up to 12 weeks

• Gastrointestinal symptom assessment via Hospital Anxiety and Depression Scale

  Up to 12 weeks

• Gastrointestinal symptom assessment via Patient Health Questionnaire

  Up to 12 weeks

Study Arms (1)

Cognitive Behavioral Therapy

EXPERIMENTAL

Patients in the cognitive behavioral therapy group will be asked to undergo a 8-week CBT trial. An online videoconferencing link will be used to deliver CBT virtual sessions that will be approximately 60 minutes in length. Each session will be conducted by a clinical psychology doctoral student, supervised by a licensed psychologist. Patients will also undergo careful phenotyping pre- and post intervention with brain MRI, AFT, and NDT.

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

Treatment sessions will use active, structured techniques to alter distorted thoughts, with a focus on acquiring and practicing cognitive and emotional modulatory skills. In particular, cognitive restructuring is used to help patients recognize the relationships between thoughts, feelings, and behaviors. Patients learn to identify, evaluate, and challenge negative thoughts. Patients will also learn behavioral strategies to decrease avoidance behavior and increase toleration of physical sensations.

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged 18 - 65 years old (inclusive)
• 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
• An idiopathic etiology
• 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.
• Body mass index (BMI) ≥ 17.5 kg/m2
• Have not previously received CBT for coping with chronic illness
• Have access to a computer with internet access
• Speak, write, and understand English
• 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.

You may not qualify if:

• Inability to comply with or complete GES test (including allergy to eggs)
• Use of narcotic analgesics greater than three days per week
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Gastroparesis

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Braden Kuo, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Karlson

CONTACT

617-726-0196; rkarlson@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 21, 2018
• Study Start: December 7, 2018
• Primary Completion: February 25, 2026
• Study Completion (Estimated): February 25, 2027
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

US (1)