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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05587127
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Behavioral Therapy — BEHAVIORAL
    Eight 1-hour sessions delivered weekly via the MGH-approved secure video platform Enterprise Zoom. Skills include: education about gut-brain regulation and weight loss, and regularizing eating to improve hunger and satiety cues; techniques to facilitate weight gain with targets of increased food volume and variety; and plan for maintenance of treatment gains.

Study Details

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.

Key Dates

Start date
Nov 30, 2022
Status verified
Sep 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Cognitive Behavioral Therapy
    Subjects will receive cognitive behavioral therapy for functional dyspepsia with avoidant restrictive food intake disorder.
  • No Intervention: Usual Care
    In the usual care condition, participants will be allowed to continue with treatment they are already receiving at the time of randomization, and we will collect detailed data on the nature of these interventions. Participants will be allowed to pursue non study treatments in this condition.

Primary Outcome Measure

Enrollment [ Time Frame: Throughout study completion, an average of 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Helen Burton Murray, PhD
[email protected]
617-643-7884
Blythe Peterson, BS
[email protected]
617-643-7884
Helen Burton Murray, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital· Boston, MA

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