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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
50
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.
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGEnrollment
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.
Time frame: Throughout study completion, an average of 3 years
Assessment completion
At the end of the study, we will calculate the percentage of participants who complete all assessments in each CBT and usual care groups.
Time frame: Throughout study completion, an average of 3 years
Retention
At the end of the study, we will calculate the percentage of participants who complete at least 6 of the 8 CBT sessions.
Time frame: Throughout study completion, an average of 3 years
Interventionist Fidelity ratings
At the end of the study, we will calculate fidelity, which measures the percentage of sessions that 100% of the CBT content was delivered.
Time frame: Throughout study completion, an average of 3 years
Client Satisfaction
The Client Satisfaction Questionnaire (CSQ) is an 8 item self-report measure that assesses treatment satisfaction. Higher scores indicate greater treatment satisfaction.
Time frame: Week 12
Short Form Nepean Dyspepsia Inventory (SF-NDI)
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.
Time frame: Weeks 0, 6, and 12
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