Recruiting

Exposure-Based CBT

Sponsor:

Massachusetts General Hospital

Code:

NCT05587127

Conditions

Avoidant/Restrictive Food Intake Disorder

Dyspepsia

Feeding and Eating Disorders

Cognitive Behavioral Therapy

Appetite Regulation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy

Study Details

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

Study ID

NCT05587127

Start date

Nov 30, 2022

Status verified date

Sep, 2025

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Cognitive Behavioral Therapy

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

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.

Interventions

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.

Primary outcome measure

  • Enrollment [ Time Frame: Throughout study completion, an average of 3 years ]
  • Assessment completion [ Time Frame: Throughout study completion, an average of 3 years ]
  • Retention [ Time Frame: Throughout study completion, an average of 3 years ]
  • Interventionist Fidelity ratings [ Time Frame: Throughout study completion, an average of 3 years ]
  • Client Satisfaction [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Helen Burton Murray, PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 25, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-09-25.