Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
NCT ID: NCT05587127
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2022-11-30
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Cognitive Behavioral Therapy
Subjects will receive cognitive behavioral therapy for functional dyspepsia with avoidant restrictive food intake disorder.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Helen B. Murray, PHD
Principal Investigator
Principal Investigators
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Helen Burton Murray, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022P001765
Identifier Type: -
Identifier Source: org_study_id
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