Dietary Counselling Plus Omega-3 Supplementation in the Treatment of Generalized Anxiety Disorder

NCT05573672 | Completed Phase 2 Results

• 1 other identifier: CCNM_EASe-GADCT_2201v3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the feasibility and acceptability of a combination intervention including dietary counselling and omega-3 fatty acid supplementation among women with generalized anxiety disorder. It will be randomized and wait-list controlled with 25 participants completing the 12-week intervention immediately and the other 25 participants completing the intervention after a 12-week wait period.

Conditions

Generalized Anxiety Disorder

Keywords

anxiety; generalized anxiety disorder; nutrition; diet; omega-3; lifestyle

Outcome Measures

Primary Outcomes (2)

• Feasibility of Participant Recruitment and Intervention Delivery

  Feasibility will be assessed by measuring the time to recruit and enrol 50 participants. Additionally, we will compare the intervention protocol with the intervention activities delivered.

  8 months

• Acceptability of the Intervention by Study Participants

  Acceptability will be assessed by measuring the number of diet counselling sessions completed. Additionally, participants will be asked to complete a brief satisfaction survey concerning the participant's level of satisfaction with the program, the aspects which were helpful or unhelpful, and opportunities for improvement. A sub-sample will be recruited to participate in a brief focus group in order to obtain more detailed qualitative responses about the participant experience and participant satisfaction.

  12 weeks

Secondary Outcomes (12)

• Anxiety Symptom Severity: The Beck Anxiety Inventory

  12 weeks

• Diet Quality: MEDI-LITE Questionnaire

  12 weeks

• Quality of Life: PROMIS-29 v2.1

  12 weeks

• Mindful Eating Behaviour: Mindful Eating Questionnaire

  12 weeks

• Self Efficacy: General Self-Efficacy Scale

  12 weeks

Study Arms (2)

Immediate Start

EXPERIMENTAL

Dietary Counselling (7 bi-weekly sessions) plus omega-3 supplementation

Combination Product: Dietary Counselling combined with Omega-3 Supplementation

Waitlist Control

NO INTERVENTION

Participants will wait 12 weeks and then complete the same intervention as the Immediate Start arm.

Interventions

Dietary Counselling combined with Omega-3 Supplementation COMBINATION_PRODUCT

Dietary Counselling: Seven, bi-weekly counselling sessions over 12-weeks conducted by a licensed Naturopathic Doctor. Each session will be 45-60 minutes in length. The recommendations will be based on the Mediterranean diet and the results of a recent scoping review which summarized the research related to diet and anxiety. The intervention will include motivational interviewing, mindful eating techniques, goal setting and action planning. A range of resources related to meal planning, recipes, cooking education, shopping lists and tracking sheets will be provided in an individualized manner. Dietary Supplement: AquaOmega High EPA Omega-3 capsules will be taken at a dose of four capsules, once daily (containing a total of 3456 mg of omega-3 fatty acids: 2659mg of Eicosapentaenoic acid (EPA), 532mg of docosahexaenoic acid (DHA), and 800IU of Vitamin D), with a meal.

Immediate Start

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Participants who identify as women are eligible to participate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A person aged 18-65 years who currently identifies as a woman.
• Primary diagnosis of generalized anxiety disorder based on a clinical interview with a psychiatrist using the DSM-5 criteria.
• Moderate to severe anxiety as defined as a Beck Anxiety Inventory score of 22 or higher.
• Low quality diet as defined as a score of 8.5 or less on the MEDI-LITE tool.
• All psychiatric medication, psychotherapy and natural health products stable for the past four weeks.
• Established therapeutic relationship with a family doctor, psychiatrist, or clinical psychologist as their primary source of mental health care.
• Ability to swallow capsules.
• Ability to read in English and provide informed consent

You may not qualify if:

• Currently meets DSM-5 criteria for obsessive-compulsive disorder, bipolar disorder, a psychotic disorder, an eating disorder, or substance use disorder based on clinical interview with a psychiatrist.
• Current high level of suicidality assessed by trial psychiatrist using the Columbia Suicide Severity Scale.
• Starting or changing the dose of a psychiatric medication, psychotherapy, or natural health products in the past four weeks.
• Severe food allergies, intolerances or aversions that would prevent the individual from modifying their diet (includes aversion to bovine gelatin which is a component of the fish oil supplement).
• Current participation in a program, research study or treatment plan involving diet or lifestyle modification.
• Baseline Omega Score of \>5% (suggesting adequacy of omega-3 fatty acids).
• Supplementation of greater than 4000IU of vitamin D daily for at least one month in the previous six months.
• Allergy to fish or any of the non-medicinal ingredients in the study product.

Sponsors & Collaborators

• The Canadian College of Naturopathic Medicine: lead
• McGill University: collaborator
• Netherlands Open University: collaborator
• Massachusetts General Hospital: collaborator
• Ekhagastiftelsen: collaborator
• AquaOmega: collaborator
• Lipid Analytical Laboratories Inc: collaborator
• Mitacs: collaborator

Study Sites (1)

Canadian College of Naturopathic Medicine

Toronto, Ontario, M2K 1E2, Canada

Location

Related Publications (2)

• Aucoin M, LaChance L, van der Wurff I, McLaren M, Monteiro S, Miller S, Jenkins A, Sabri E, Cooley K. 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'). Nutr Neurosci. 2025 Jun;28(6):635-648. doi: 10.1080/1028415X.2024.2403901. Epub 2024 Sep 24.

  PMID: 39316026 DERIVED

• Aucoin M, LaChance L, van der Wurff I, Miller S, Naidoo U, Jenkins A, Cooley K. 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 Feasibility Stud. 2023 Nov 10;9(1):186. doi: 10.1186/s40814-023-01414-y.

  PMID: 37950301 DERIVED

Related Links

• Study Protocol

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Monique Aucoin
• Organization: Canadian College of Naturopathic Medicine

maucoin@ccnm.edu

416 498 1255

Study Officials

• Monique Aucoin, ND MSc

  Canadian College of Naturopathic Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Collection of height and weight data will be completed by an individual blind to participant allocation. The statistician completing data analysis will be blind to allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be wait-list controlled. Participants will be randomized to one of two groups. One group will begin the intervention immediately. The other will wait 12 weeks and then complete the intervention.

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 10, 2022
• Study Start: August 12, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: April 4, 2025
• Results First Posted: April 4, 2025

Record last verified: 2025-03

Locations

CA (1)