Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia

A Randomized Controlled Trial of Exposure-Based Cognitive Behavioral Treatment for Avoidant/Restrictive Food Intake in Functional Dyspepsia

Randomized controlled trial of an exposure-based behavioral treatment (CBT) in adults with functional dyspepsia who meet criteria for avoidant/restrictive food intake disorder (ARFID) with weight loss.

Study Overview

• Status: Recruiting
• Conditions: Feeding and Eating Disorders; Functional Dyspepsia; Dyspepsia; Avoidant/Restrictive Food Intake Disorder; Appetite Regulation; Cognitive Behavioral Therapy; Post-prandial Distress Syndrome; Behavioral Medicine
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy

Detailed Description

The purpose of this study is to conduct a randomized controlled trial (RCT) of a cognitive-behavioral treatment (CBT) compared to usual care as the control with adults with functional dyspepsia who also meet criteria for avoidant/restrictive food intake disorder (ARFID). Participants randomized into the CBT group will receive eight 1-hour sessions delivered weekly via the MGH-approved secure video platform Enterprise Zoom while the usual care group will be allowed to continue with treatment they are already receiving at the time of randomization. Participants in the usual care group will be offered CBT after study participation. We will determine the feasibility and acceptability of the CBT and explore changes in clinical outcomes and preliminary mechanisms.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Blythe Peterson, BS; Phone Number: 617-643-7884; Email: GIbehavioralresearch@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Helen Burton Murray, PhD; Phone Number: 617-643-7884; Email: GIbehavioralresearch@mgh.harvard.edu
      • Principal Investigator: Helen Burton Murray, PhD
      • Contact: Blythe Peterson, BS; Phone Number: 617-643-7884; Email: GIbehavioralresearch@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Age at least 18 years at screening visit
• Rome IV Functional Dyspepsia post-prandial distress type (with or without epigastric pain syndrome)
• Negative upper endoscopy or upper radiographic GI series to rule out structural/organic cause for FD
• Avoidant/Restrictive Food Intake Disorder (ARFID) diagnosis (by the Structured Clinical Interview for DSM-5; SCID-5 at Screening visit)
• ≥5% weight loss from weight after functional dyspepsia symptom onset (at Screening visit)
• Stable for outpatient care (based on the American Psychiatric Association Practice Guideline for the Treatment of Patients with Eating Disorders)
• No previous history of CBT for functional dyspepsia or ARFID
• Computer/internet webcam access
• Fluency in English
• Stable dose for 30 days if on any medication

Exclusion Criteria

• Inability to provide informed consent
• Presence of other conditions that could explain the patient's symptoms by chart:

Pyloric or intestinal obstruction (by EGD, UGI, or Abdominal CT) Active H.pylori infection (by CLO test or stool antigen test) Active inflammatory bowel disease Eosinophilic gastroenteritis or eosinophilic esophagitis Acute renal failure Chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis or peritoneal dialysis Acute liver failure Any acute gastrointestinal process Any plausible structural or metabolic causes Heartburn as predominant symptom History of peptic ulcer

• Symptom resolution with antisecretory therapy (PPI use for other reasons that did not resolve FD symptoms will be allowed)
• History of gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection)
• History of any serious medical condition (e.g., cancer)
• Use of narcotic analgesics greater than three days per week
• Current pregnancy or breastfeeding within the last 8 weeks
• Uncontrolled diabetes (indicated by HbA1c ≥7%) by chart
• Intellectual disability by history
• Current substance/alcohol use disorder within the past month
• Current/history of psychosis (by Mini-International Neuropsychiatric Interview (MINI-Screen)
• Current mania (by Mini-International Neuropsychiatric Interview (MINI-Screen) (defined as any manic episodes within the past 12 months)
• Active suicidal ideation (by MINI-Screen)
• Psychiatric disorder that would warrant independent attention (by Mini-International - Neuropsychiatric Interview (MINI-Screen))
• Current enteral or parenteral feeding
• Plans to initiate another psychotherapy or pregnancy in the concurrent study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioral Therapy; Subjects will receive cognitive behavioral therapy for functional dyspepsia with avoidant restrictive food intake disorder.	Behavioral: Cognitive Behavioral Therapy; Eight 1-hour sessions delivered weekly via the MGH-approved secure video platform Enterprise Zoom. Skills include: education about gut-brain regulation and weight loss, and regularizing eating to improve hunger and satiety cues; techniques to facilitate weight gain with targets of increased food volume and variety; and plan for maintenance of treatment gains.
No Intervention: Usual Care; In the usual care condition, participants will be allowed to continue with treatment they are already receiving at the time of randomization, and we will collect detailed data on the nature of these interventions. Participants will be allowed to pursue non study treatments in this condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment	At the end of the study, we will calculate the percentage of participants who consent to initiate the study from the total who are offered.	Throughout study completion, an average of 3 years
Assessment completion	At the end of the study, we will calculate the percentage of participants who complete all assessments in each CBT and usual care groups.	Throughout study completion, an average of 3 years
Retention	At the end of the study, we will calculate the percentage of participants who complete at least 6 of the 8 CBT sessions.	Throughout study completion, an average of 3 years
Interventionist Fidelity ratings	At the end of the study, we will calculate fidelity, which measures the percentage of sessions that 100% of the CBT content was delivered.	Throughout study completion, an average of 3 years
Client Satisfaction	The Client Satisfaction Questionnaire (CSQ) is an 8 item self-report measure that assesses treatment satisfaction. Higher scores indicate greater treatment satisfaction.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form Nepean Dyspepsia Inventory (SF-NDI)	The Short Form Nepean Dyspepsia Inventory (SF-NDI) includes a 15 item symptoms checklist to assess functional dyspepsia symptom severity. It also includes 10 items scored on a 5-point Likert scale measuring functional dyspepsia-related quality of life; subscales include interference with daily activities, knowledge/control, tension, work/study, and eating/drinking.	Weeks 0, 6, and 12

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Helen Burton Murray, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: October 16, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Avoidant Restrictive Food Intake Disorder; Dyspepsia; Feeding and Eating Disorders; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: 2022P001765; K23DK131334-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No