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

Not Applicable

Recruiting

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

• Registration Number: NCT05587127
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-10-16
• Study First Posted: 2022-10-19
• Study Start: 2022-11-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2025-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy	Cognitive Behavioral Therapy	Subjects will receive cognitive behavioral therapy for functional dyspepsia with avoidant restrictive food intake disorder.

Primary Outcome Measures

Name	Time	Method
Retention	Throughout 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 ratings	Throughout 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.
Enrollment	Throughout 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 completion	Throughout 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.
Client Satisfaction	Week 12	The Client Satisfaction Questionnaire (CSQ) is an 8 item self-report measure that assesses treatment satisfaction. Higher scores indicate greater treatment satisfaction.

Secondary Outcome Measures

Name	Time	Method
Short Form Nepean Dyspepsia Inventory (SF-NDI)	Weeks 0, 6, and 12	The Short Form Nepean Dyspepsia Inventory (SF-NDI) includes a 15 item symptoms checklist to assess functional dyspepsia symptom severity. It also includes 10 items scored on a 5-point Likert scale measuring functional dyspepsia-related quality of life; subscales include interference with daily activities, knowledge/control, tension, work/study, and eating/drinking.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States