Central and Peripheral Effects of Cognitive Behavioral Therapy on Brain-Gut Axis Signaling in Gastroparetic Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastroparesis
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Detailed Description
This randomized, controlled trial will examine the effects of cognitive behavioral therapy (CBT) on gastroparesis symptoms (including pain related brain circuitry). CBT reduces pain intensity, negative affect, and disability among patients with chronic pain, though there is a good deal of individual variability in treatment effects. Treatment gains following CBT are maintained or enhanced at 6 to 12-month follow-up. This study will examine the brain circuitry underlying these effects. In addition, as measures of gastroparesis symptoms and pain are correlated with other, more general, measures of negative affect (e.g., depression, anxiety), we will evaluate the specificity of the hypothesized effects by running the proposed statistical models both with and without inclusion of these conceptually overlapping factors. Based on pervious findings and published data, we expect that treatment-associated changes in pain and depression will likely share 10-20% of their variance. Treatment sessions will use active, structured techniques to alter distorted thoughts, with a focus on acquiring and practicing cognitive and emotional modulatory skills. CBT is based on a pain self-management paradigm, and involves the identification and reduction of maladaptive pain-related cognitions (i.e., catastrophizing) using techniques such as relaxation, thought-stopping, distraction, etc. CBT prominently emphasizes in-vivo practice during each session, and features home practice using written exercises. 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. In our protocol, each of the 8 weekly sessions will last for approximately 90 minutes and will be conducted or supervised by a trained psychologist. Following CBT, negative emotions are no longer closely linked to pain, suggesting that CBT provides patients with the skills to modulate and buffer their negative emotions such as catastrophizing. Subjects will undergo pre- and post-treatment testing through a variety of methods including brain MRI with associated physiological data, 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.
Investigators
Braden Kuo
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM)
Time Frame: Up to 12 weeks
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.
Secondary Outcomes
- Gastrointestinal symptom assessment via Hospital Anxiety and Depression Scale(Up to 12 weeks)
- Gastrointestinal symptom assessment via Brief Pain Inventory(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)
- Electrocardiogram acquired during MRI scans(Baseline, and up to 2 hour post-intervention)
- Gastrointestinal symptom assessment via Patient Health Questionnaire(Up to 12 weeks)
- Gastrointestinal symptom assessment via Pain Catastrophizing Scale(Up to 12 weeks)
- Gastrointestinal symptom assessment via Coping Strategies Questionnaire(Up to 12 weeks)
- Gastrointestinal symptom assessment via Eysenck Personality Inventory(Up to 12 weeks)
- Respiration during MRI scans(Baseline, and up to 2 hour post-intervention)
- Gastrointestinal symptom assessment via Neuropathy Total Symptoms Score(Up to 12 weeks)
- Gastrointestinal symptom assessment via Perceived Stress Scale(Up to 12 weeks)
- Multivoxel 3D Proton Resonance Spectroscopy(Baseline, and up to 2 hours post-intervention)
- Electrogastrogram acquired during MRI scans(Baseline, and up to 2 hour post-intervention)
- Gastrointestinal symptom assessment via Short Form 36 Health Survey(Up to 12 weeks)
- Gastrointestinal symptom assessment via PainDETECT(Up to 12 weeks)
- Gastrointestinal symptom assessment via PTSD Questionnaire - PCL-5(Up to 12 weeks)
- Gastrointestinal symptom assessment via Early Life Trauma Inventory Self Report - Short Form(Up to 12 weeks)
- Gastrointestinal symptom assessment via Pain Self-Efficacy Questionnaire(Up to 12 weeks)
- Structural fMRI, resting fMRI, fMRI during catastrophizing test(Baseline, and up to 2 hours post-intervention)
- Abdominal Quantitative Sensory Testing (QST)(Baseline, and up to 1 hour post-intervention)
- Autonomic Function Testing (AFT)(Baseline, and up to 1 hour post-intervention)