Trials / Recruiting
RecruitingNCT05587127
Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
A Randomized Controlled Trial of Exposure-Based Cognitive Behavioral Treatment for Avoidant/Restrictive Food Intake in Functional Dyspepsia
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Massachusetts General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
The purpose of this study is to conduct a randomized controlled trial (RCT) of a cognitive-behavioral treatment (CBT) compared to usual care as the control with adults with functional dyspepsia who also meet criteria for avoidant/restrictive food intake disorder (ARFID). Participants randomized into the CBT group will receive eight 1-hour sessions delivered weekly via the MGH-approved secure video platform Enterprise Zoom while the usual care group will be allowed to continue with treatment they are already receiving at the time of randomization. Participants in the usual care group will be offered CBT after study participation. We will determine the feasibility and acceptability of the CBT and explore changes in clinical outcomes and preliminary mechanisms.
Conditions
- Avoidant/Restrictive Food Intake Disorder
- Dyspepsia
- Feeding and Eating Disorders
- Cognitive Behavioral Therapy
- Appetite Regulation
- Functional Dyspepsia
- Post-prandial Distress Syndrome
- Behavioral Medicine
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Cognitive Behavioral Therapy | 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. |
Timeline
- Start date
- 2022-11-30
- Primary completion
- 2027-05-01
- Completion
- 2027-05-01
- First posted
- 2022-10-19
- Last updated
- 2025-09-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05587127. Inclusion in this directory is not an endorsement.