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other·psychiatry, nutrition, clinical nutrition, micronutrients, clinical trial·PMC10636887

Dietary counselling plus omega-3 supplementation in the treatment of generalized anxiety disorder: protocol for a randomized wait-list controlled pilot trial (the “EASe-GAD Trial”)

Pilot and Feasibility Studies · 7 authors, 12 centres

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TL;DR

This paper describes the protocol for a randomized wait-list controlled pilot trial of dietary counselling and omega-3 supplementation for adult women with generalized anxiety disorder. The primary goal is to assess the feasibility and acceptability of this intervention, not its clinical efficacy.

Full summary

727 CHARS

This is a protocol paper for a randomized, wait-list controlled pilot trial (the EASe-GAD Trial) with a planned sample of 50 adult women with generalized anxiety disorder. The intervention consists of 12 weeks of dietary counselling (seven sessions) and omega-3 supplementation, designed using Social Cognitive Theory. The primary objective is to evaluate the feasibility and acceptability of the program, assessed via recruitment rates, session attendance, and participant satisfaction surveys. Secondary objectives include measuring changes in anxiety severity (Beck Anxiety Inventory), quality of life, mindful eating, diet quality, and various blood biomarkers. The study is a protocol, so no efficacy results are reported.

STUDY TYPE

other

SPECIALTY

psychiatry

SUMMARISED BY

AI pipeline

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ORIGINAL PAPER

PMC10636887

Dietary counselling plus omega-3 supplementation in the treatment of generalized anxiety disorder: protocol for a randomized wait-list controlled pilot trial (the “EASe-GAD Trial”)

Pilot and Feasibility Studies

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ABSTRACT

Background Anxiety disorders are prevalent and disabling conditions involving excessive worry and tension. Generalized anxiety disorder (GAD), the most common anxiety disorder, affects 5% of individuals from high-income countries and many individuals report that treatment options are not accessible, effective, or tolerable. Clinical evidence suggests that nutrition interventions, based on the Mediterranean diet and supplementation of omega-3 fatty acids, can significantly improve symptoms of depression; however, the effect of nutrition interventions on anxiety symptoms has not been studied in a clinical population. The primary objective of the present study is to assess the feasibility and acceptability of a dietary counselling and omega-3 fatty acid supplementation intervention delivered to adult women with GAD. The secondary objectives include assessing changes in anxiety symptom severity, assessing changes in quality of life, assessing changes in biomarkers, and evaluating the components of the program. Methods This study is a randomized, wait-list controlled pilot trial delivering a 12-week, dietary counselling intervention and omega-3 supplementation to 50 adult women with GAD. Participants will complete seven individual counselling sessions which include education, personalized recommendations, mindful eating techniques, motivational interviewing, and goal setting. They will be provided with recipes, instructional videos, and food items. The intervention is designed based on the Social Cognitive Theory and previous research that has been done by the author team to identify dietary constituents with the most evidence to support their use in the treatment of anxiety disorders. Questionnaires and blood work will be completed at baseline, after the waiting period (for those in the waitlist group), and after the intervention. Discussion Results from this study will lay the foundation for future large-scale studies in this area and may provide preliminary evidence of the role of diet counselling and omega-3 supplementation in the management of GAD. Research on the role of nutrition in psychiatric care has been identified as a priority by a number of international organizations. The present trial directly addresses the call for the research that is most needed to advance the field. Trial registration This protocol was registered at ClinicalTrials.gov on October 10, 2022; NCT05573672 . Trial sponsor: The Canadian College of Naturopathic Medicine, 1255 Sheppard Ave E, Toronto, ON M2K 1E2, 416–498-1255. Steering committee: Composed of MA, LL, KC, IvdW, SM, UN, AJ. The committee meets monthly to oversee the trial. Protocol identifier: CCNM_EASe-GADCT_2201v4. Supplementary Information The online version contains supplementary material available at 10.1186/s40814-023-01414-y.

CITATION EXPORT

Monique Aucoin, Laura LaChance, Inge van der Wurff et al.. Dietary counselling plus omega-3 supplementation in the treatment of generalized anxiety disorder: protocol for a randomized wait-list controlled pilot trial (the “EASe-GAD Trial”). Pilot and Feasibility Studies. (2023). https://doi.org/10.1186/s40814-023-01414-y

AUTHORS

7 · 12 CENTRES

Monique Aucoin, Laura LaChance, Inge van der Wurff, Sean Miller, Umadevi Naidoo, Andrew Jenkins, Kieran Cooley

1https://ror.org/03pjwtr87grid.418588.80000 0000 8523 7680Canadian College of Naturopathic Medicine, Toronto, Canada
2https://ror.org/01r7awg59grid.34429.380000 0004 1936 8198University of Guelph, Guelph, Canada
3https://ror.org/01pxwe438grid.14709.3b0000 0004 1936 8649McGill University, Montreal, Canada
4https://ror.org/03s3dhf22grid.416526.2St. Mary’s Hospital, Montreal, Canada
5https://ror.org/018dfmf50grid.36120.360000 0004 0501 5439Health Psychology, Faculty of Psychology, Open University of the Netherlands, Utrecht, Netherlands
6Peer Connections Manitoba, Winnipeg, Canada
7https://ror.org/002pd6e78grid.32224.350000 0004 0386 9924Massachusetts General Hospital, Boston, USA
8grid.38142.3c000000041936754XHarvard Medical School, Boston, USA
9Lipid Analytical Laboratory, Guelph, Canada
10https://ror.org/001xkv632grid.1031.30000 0001 2153 2610Southern Cross University, Lismore, Australia
11https://ror.org/03f0f6041grid.117476.20000 0004 1936 7611University of Technology Sydney, Ultimo, Australia
12Pacific College of Health and Science, San Diego, USA