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New treatment option for Avoidant/Restrictive Food Intake Disorder
Official title Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
ClinicalTrials.gov ID: NCT05587127
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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)...
- 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.