Cognitive Behavioral Therapy for Food Intake Issues in Dyspepsia
A Randomized Controlled Trial of Exposure-Based Cognitive Behavioral Treatment for Avoidant/Restrictive Food Intake in Functional Dyspepsia
This study is testing whether a special kind of therapy delivered online can help adults with functional dyspepsia and food intake issues feel better and improve their eating habits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05587127 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an exposure-based cognitive-behavioral therapy (CBT) for adults suffering from functional dyspepsia who also have avoidant/restrictive food intake disorder (ARFID) with weight loss. Participants will be randomly assigned to receive either eight weekly sessions of CBT via a secure video platform or continue with their usual care. The study aims to assess the feasibility and acceptability of the CBT approach while exploring changes in clinical outcomes and potential mechanisms of improvement. The usual care group will have the option to receive CBT after the study concludes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with functional dyspepsia and a diagnosis of avoidant/restrictive food intake disorder who have experienced significant weight loss.
Not a fit: Patients with other conditions that could explain their symptoms or those who have previously undergone CBT for similar issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve eating behaviors and overall health in patients with ARFID and functional dyspepsia.
How similar studies have performed: While cognitive-behavioral therapy has been effective in treating various eating disorders, this specific application for ARFID in the context of functional dyspepsia is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Helen Burton Murray, PhD — Massachusetts General Hospital
- Study coordinator: Blythe Peterson, BS
- Email: GIbehavioralresearch@mgh.harvard.edu
- Phone: 617-643-7884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.