Dietary counseling plus omega-3 supplementation in the treatment of generalized anxiety disorder: results of a randomized wait-list controlled pilot trial (the 'EASe-GAD Trial').

Objectives: Clinical evidence suggests that nutrition interventions can significantly improve symptoms of major depressive disorder; however, the effect on clinical anxiety symptoms in individuals with anxiety disorders has not been studied. The primary objective of the present study was to assess the feasibility and acceptability of a nutrition intervention. The secondary objectives included assessing changes in anxiety symptom severity, diet quality, self-efficacy, mindful eating, quality of life, and biomarkers.

Methods: This study was a randomized, wait-list controlled pilot trial delivering a 12-week, biweekly dietary counseling intervention and omega-3 supplementation to 50 adult women with generalized anxiety disorder. Questionnaires and blood work were completed at baseline, after the waiting period, and after the intervention.

Results: 443 individuals expressed interest within eight months; 50 met the criteria for enrollment. The mean number of sessions attended was 6.4. Final questionnaires were completed by 46 participants. Eighty-four percent of participants strongly agreed with the statement 'My experience during this study was positive'. The mean anxiety symptom severity score in the intervention group was 26.2 (95% CI 22.94-29.48) at baseline and 11.0 (95% CI 8.05-13.87) at week 12. The mean diet quality score was 7.2 (95% CI 6.32-8.10) and 10.5 (95% CI 9.55-11.49) at baseline and week 12, respectively. Among the waitlist participants, the mean baseline anxiety score was 29.3 (95% CI 24.73-33.91) and 26.8 (95% CI 22.09-31.56) at week 12.

Discussion: This study was feasible and acceptable. Participation in the intervention was associated with a decrease in anxiety symptoms. These findings lay the foundation for large-scale studies. Trial registration: ClinicalTrials.gov NCT05573672.