NCT05587127 Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
| NCT ID | NCT05587127 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Avoidant/Restrictive Food Intake Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-11-30 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2022-11-30 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Helen Burton Murray, PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05587127 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Avoidant/Restrictive Food Intake Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05587127 currently recruiting?
Yes, NCT05587127 is actively recruiting participants. Contact the research team at GIbehavioralresearch@mgh.harvard.edu for enrollment information.
Where is the NCT05587127 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05587127 clinical trial?
NCT05587127 is sponsored by Massachusetts General Hospital. The principal investigator is Helen Burton Murray, PhD at Massachusetts General Hospital. The trial plans to enroll 50 participants.