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

This study is testing a type of talk therapy called Cognitive Behavioral Therapy (CBT) for adults who have both functional dyspepsia (a condition causing ongoing stomach pain or discomfort) and Avoidant/Restrictive Food Intake Disorder (ARFID), which involves avoiding certain foods or limiting how much you eat. The CBT involves eight weekly online sessions focusing on understanding gut-brain connections and improving eating habits. Researchers want to see if this CBT is practical and acceptable, and how it might change symptoms. You could be in the CBT group or a group that continues with your usual care, with the option to receive CBT after the study. The study aims to enroll 50 participants.

Study design
This is a randomized controlled trial comparing Cognitive Behavioral Therapy (CBT) to usual care. About 50 adults will participate.
What's involved
If in the CBT group, you would attend eight 1-hour online sessions weekly. The study will track your enrollment, assessment completion, and retention over an average of 3 years.
Compensation
Not stated in the trial record.
Follow-up
The study will track participants for an average of 3 years to measure enrollment, assessment completion, and retention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05587127

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

Recruiting
NAAges 18+Interventional
Massachusetts General Hospital
~50 participants
Updated 2025-09-25 on ClinicalTrials.gov
What's tested:Cognitive Behavioral Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Enrollment
Measured over Throughout study completion, an average of 3 years
+4 more outcomes measured

Conditions

Avoidant/Restrictive Food Intake Disorder
Dyspepsia
Feeding and Eating Disorders
Cognitive Behavioral Therapy
Appetite Regulation
Functional Dyspepsia
Post-prandial Distress Syndrome
Behavioral Medicine

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NCT05587127

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Helen Burton Murray, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Blythe Peterson, BS
[email protected]
617-643-7884
Email the study team

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Eligibility criteria

Inclusion

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

Inability to provide informed consent
Presence of other conditions that could explain the patient's symptoms by chart:
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

What this trial measures

  • EnrollmentThroughout study completion, an average of 3 years

    At the end of the study, we will calculate the percentage of participants who consent to initiate the study from the total who are offered.

  • Assessment completionThroughout study completion, an average of 3 years

    At the end of the study, we will calculate the percentage of participants who complete all assessments in each CBT and usual care groups.

  • RetentionThroughout study completion, an average of 3 years

    At the end of the study, we will calculate the percentage of participants who complete at least 6 of the 8 CBT sessions.

  • Interventionist Fidelity ratingsThroughout study completion, an average of 3 years

    At the end of the study, we will calculate fidelity, which measures the percentage of sessions that 100% of the CBT content was delivered.

  • Client SatisfactionWeek 12

    The Client Satisfaction Questionnaire (CSQ) is an 8 item self-report measure that assesses treatment satisfaction. Higher scores indicate greater treatment satisfaction.