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

NCT05587127 | Recruiting

• 2 other identifiers: 2022P001765K23DK131334-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Avoidant/Restrictive Food Intake Disorder; Dyspepsia; Feeding and Eating Disorders; Cognitive Behavioral Therapy; Appetite Regulation; Functional Dyspepsia; Post-prandial Distress Syndrome; Behavioral Medicine

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Short Form Nepean Dyspepsia Inventory (SF-NDI)

  Weeks 0, 6, and 12

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

Subjects will receive cognitive behavioral therapy for functional dyspepsia with avoidant restrictive food intake disorder.

Behavioral: Cognitive Behavioral Therapy

Usual Care

NO INTERVENTION

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.

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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.

Cognitive Behavioral Therapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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))

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Avoidant Restrictive Food Intake Disorder; Dyspepsia; Feeding and Eating Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Helen Burton Murray, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Blythe Peterson, BS

CONTACT

617-643-7884; GIbehavioralresearch@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 19, 2022
• Study Start: November 30, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

US (1)