Brief cognitive-behavioral treatment for avoidant/restrictive food intake disorder in the context of functional dyspepsia: Study protocol for a feasibility randomized controlled trial.
Avoidant/restrictive food intake disorder
Cognitive-behavioral therapy
Disorders of gut-brain interaction
Feasibility
Feeding and eating disorders
Functional dyspepsia
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
Nov 2023
Nov 2023
Historique:
received:
22
05
2023
revised:
11
09
2023
accepted:
15
09
2023
medline:
27
11
2023
pubmed:
19
9
2023
entrez:
18
9
2023
Statut:
ppublish
Résumé
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. We will randomize adults with FD who meet criteria for ARFID with ≥5% weight loss (N = 50) in a 1:1 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. 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.
Sections du résumé
BACKGROUND
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
METHODS
We will randomize adults with FD who meet criteria for ARFID with ≥5% weight loss (N = 50) in a 1:1 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
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.
Identifiants
pubmed: 37722485
pii: S1551-7144(23)00259-8
doi: 10.1016/j.cct.2023.107336
pii:
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
107336Informations de copyright
Copyright © 2023 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest JSW and LVO have no conflicts to declare. HBM and JJT receive royalties from Oxford University Press for their forthcoming book on rumination syndrome. BL receives royalties from Pear Therapeutics Inc. for a cognitive-behavioral treatment manual for irritable bowel syndrome. BH receives grant support from Analysis Group, Celgene (Bristol-Myers Squibb), Verily Life Sciences, Novartis, Merck Serono, and Genzyme. LVO receives grant support from the Nestlé. Consultancy/Advisory Board: Nestlé, Danone, The Akkermansia Company; LVO is an also associate research professor funded of the KU Leuven Special Research Fund. LK receives royalties from Routledge for her edited book Handbook of Psychogastroenterology. EAL is on the scientific advisory board and has a financial interest in OXT Therapeutics, a company developing an intranasal oxytocin and long-acting analogs of oxytocin to treat obesity and metabolic disease; EAL also receives royalties from UpToDate. BK has received research support from AstraZeneca, Takeda, Gelesis, Medtronic, Genzyme and has served as a consultant to Shire, Takeda, and Ironwood. JJT receives royalties from Cambridge University Press for the sale of her books, Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder: Children, Adolescents, and Adults and The Picky Eater's Recovery Book: Overcoming Avoidant/Restrictive Food Intake Disorder.