Brief cognitive-behavioral treatment for avoidant/restrictive food intake disorder in the context of functional dyspepsia: Study protocol for a feasibility randomized controlled trial.
Contemp Clin Trials
; 134: 107336, 2023 Nov.
Article
in En
| MEDLINE
| ID: mdl-37722485
ABSTRACT
BACKGROUND:
Avoidant/restrictive food intake disorder (ARFID) symptoms are common (up to 40%) among adults with functional dyspepsia (FD), a disorder of gut-brain interaction characterized by early satiation, post-prandial fullness, epigastric pain, and/or epigastric burning. Using an 8-session exposure-based cognitive-behavioral treatment (CBT) for adults with FD + ARFID compared to usual care (UC) alone, we aim to (1) determine feasibility, (2) evaluate change in clinical outcomes in, and (3) explore possible mechanisms of action.METHODS:
We will randomize adults with FD who meet criteria for ARFID with ≥5% weight loss (N = 50) in a 11 ratio to CBT (with continued UC) or to UC alone. A priori primary benchmarks will be ≥75% eligible participants enroll; ≥75% participants complete assessments; ≥70% participants attend 6/8 sessions; ≥70% of sessions have all content delivered; ≥70% participants rate Client Satisfaction Questionnaire scores above scale midpoint. We will also examine the size of changes in FD symptom severity and related quality of life within and between groups, and explore possible mechanisms of action.CONCLUSIONS:
Findings from this trial will inform next steps with treatment development or evaluation-either for further refinement or for next-step efficacy testing with a fully-powered clinical trial.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Feeding and Eating Disorders
/
Dyspepsia
/
Avoidant Restrictive Food Intake Disorder
Type of study:
Clinical_trials
/
Guideline
Aspects:
Patient_preference
Limits:
Adult
/
Humans
Language:
En
Journal:
Contemp Clin Trials
Journal subject:
MEDICINA
/
TERAPEUTICA
Year:
2023
Document type:
Article