Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia (NCT05587127) | Clinical Trial Compass
RecruitingNot Applicable
Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
United States50 participantsStarted 2022-11-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 (PP…
What they're measuring
1
Enrollment
Timeframe: Throughout study completion, an average of 3 years
2
Assessment completion
Timeframe: Throughout study completion, an average of 3 years
3
Retention
Timeframe: Throughout study completion, an average of 3 years
4
Interventionist Fidelity ratings
Timeframe: Throughout study completion, an average of 3 years