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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03531450
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : September 1, 2020
Information provided by (Responsible Party):
Branden Kuo, Massachusetts General Hospital

Brief Summary:
This is a single-center, randomized 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. A subset of the CBT trial patients will undergo careful phenotyping pre- and post- intervention with brain MRI, autonomic function test (AFT), gastric emptying scintigraphy (GES), wireless motility capsule test (WMC), and nutrient drink test (NDT) to determine the impact of CBT on these metrics in patients with gastroparesis. Patients randomly assigned to a standard medical treatment (SMT) group will be treated by the standard of care. Characterization of these relationships or lack thereof can help guide future development of more targeted approaches and optimize treatment strategies for gastroparesis.

Condition or disease Intervention/treatment Phase
Gastroparesis Behavioral: Cognitive Behavioral Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Central and Peripheral Effects of Cognitive Behavioral Therapy on Brain-Gut Axis Signaling in Gastroparetic Patients
Actual Study Start Date : December 7, 2018
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy
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, WMC, and NDT.
Behavioral: Cognitive Behavioral Therapy
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.

No Intervention: Standard Medical Treatment
Patients in the standard medical treatment group will not interact with any therapists and will not receive any education beyond typical clinical exposure. They will be treated by the standard of care.

Primary Outcome Measures :
  1. Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) [ Time Frame: Up to 12 weeks ]

Secondary Outcome Measures :
  1. Gastrointestinal symptom assessment via Short Form 36 Health Survey [ Time Frame: Up to 12 weeks ]
  2. Gastrointestinal symptom assessment via Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life [ Time Frame: Up to 12 weeks ]
  3. Gastrointestinal symptom assessment via Rome III Diagnostic Questionnaire for Adult Functional GI Disorders [ Time Frame: Up to 12 weeks ]
  4. Gastrointestinal symptom assessment via Hospital Anxiety and Depression Scale [ Time Frame: Up to 12 weeks ]
  5. Gastrointestinal symptom assessment via Patient Health Questionnaire [ Time Frame: Up to 12 weeks ]
  6. Gastrointestinal symptom assessment via PainDETECT [ Time Frame: Up to 12 weeks ]
  7. Gastrointestinal symptom assessment via Pain Catastrophizing Scale [ Time Frame: Up to 12 weeks ]
  8. Gastrointestinal symptom assessment via Neuropathy Total Symptoms Score [ Time Frame: Up to 12 weeks ]
  9. Gastrointestinal symptom assessment via PTSD Questionnaire - PCL-5 [ Time Frame: Up to 12 weeks ]
  10. Gastrointestinal symptom assessment via Brief Pain Inventory [ Time Frame: Up to 12 weeks ]
  11. Gastrointestinal symptom assessment via Early Life Trauma Inventory Self Report - Short Form [ Time Frame: Up to 12 weeks ]
  12. Gastrointestinal symptom assessment via Coping Strategies Questionnaire [ Time Frame: Up to 12 weeks ]
  13. Gastrointestinal symptom assessment via Pain Self-Efficacy Questionnaire [ Time Frame: Up to 12 weeks ]
  14. Gastrointestinal symptom assessment via Eysenck Personality Inventory [ Time Frame: Up to 12 weeks ]
  15. Gastrointestinal symptom assessment via Perceived Stress Scale [ Time Frame: Up to 12 weeks ]
  16. Gastrointestinal symptom assessment via Clinical Global Impression [ Time Frame: Up to 12 weeks ]
  17. Gastrointestinal symptom assessment via Credibility Expectancy [ Time Frame: Up to 12 weeks ]
  18. Gastrointestinal symptom assessment via Survey Feedback Questionnaire [ Time Frame: Up to 12 weeks ]
  19. Gastrointestinal symptom assessment via Subject Global Impression of Change [ Time Frame: Up to 12 weeks ]
  20. Gastrointestinal symptom assessment via Working Alliance Short Inventory Revised [ Time Frame: Up to 12 weeks ]
  21. Gastrointestinal symptom assessment via Client Satisfaction Questionnaire [ Time Frame: Up to 12 weeks ]
  22. Gastrointestinal transit time measured via Wireless Motility Capsule (WMC) test [ Time Frame: Baseline, and up to 1 week post-intervention ]
  23. Structural fMRI, resting fMRI, fMRI during catastrophizing test [ Time Frame: Baseline, and up to 2 hours post-intervention ]
  24. Multivoxel 3D Proton Resonance Spectroscopy [ Time Frame: Baseline, and up to 2 hours post-intervention ]
  25. Autonomic Function Testing (AFT) [ Time Frame: Baseline, and up to 1 hour post-intervention ]
  26. Abdominal Quantitative Sensory Testing (QST) [ Time Frame: Baseline, and up to 1 hour post-intervention ]
  27. Electrogastrogram acquired during MRI scans [ Time Frame: Baseline, and up to 2 hour post-intervention ]
  28. Electrocardiogram acquired during MRI scans [ Time Frame: Baseline, and up to 2 hour post-intervention ]
  29. Respiration during MRI scans [ Time Frame: Baseline, and up to 2 hour post-intervention ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 6 months 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03531450

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Contact: April Mendez 617-726-0196

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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: April Mendez         
Principal Investigator: Braden Kuo, M.D.         
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Braden Kuo, MD Massachusetts General Hospital
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Responsible Party: Branden Kuo, Principal Investigator, Massachusetts General Hospital Identifier: NCT03531450    
Other Study ID Numbers: Partners Protocol ID Pending
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Branden Kuo, Massachusetts General Hospital:
Additional relevant MeSH terms:
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Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations