Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
15

Summary

Conditions
Gastroparesis
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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...

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), wireless motility capsule test (WMC), 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.

Tracking Information

NCT #
NCT03531450
Collaborators
Not Provided
Investigators
Principal Investigator: Braden Kuo, MD Massachusetts General Hospital