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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Oct 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a type of therapy called exposure-based cognitive behavioral therapy (CBT) to help adults who have both functional dyspepsia and a condition known as avoidant/restrictive food intake disorder (ARFID). Functional dyspepsia causes discomfort or pain in the stomach after eating, while ARFID can lead to a limited appetite and weight loss. The goal of the trial is to see if this therapy can help improve eating habits and reduce symptoms for people who have lost weight due to these conditions.

To participate in this study, you need to be at least 18 years old, have been diagnosed with functional dyspepsia and ARFID, and have experienced weight loss of 5% or more since your symptoms began. The trial is currently looking for participants and is open to all genders. If you join, you can expect to engage in therapy sessions that focus on gradually helping you face your food-related fears, with the support of trained professionals. It's important to note that certain health conditions and recent treatments may exclude you from participating, so a thorough screening will be conducted to determine eligibility.

Gender

ALL

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