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Dietary Counseling + Omega-3 for Generalized Anxiety Disorder (EASe-GAD Trial)
Phase 2
Waitlist Available
Led By Monique Aucoin, ND MSc
Research Sponsored by The Canadian College of Naturopathic Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
EASe-GAD Trial Summary
This trial will study how diet and omega-3s help women with generalized anxiety disorder. 25 people will get help now, 25 after 12 weeks.
Who is the study for?
Women aged 18-65 with generalized anxiety disorder, a Beck Anxiety Inventory score of 22+, and a poor diet are eligible. They must be stable on any psychiatric meds or therapies for four weeks and have an ongoing relationship with a mental health provider. Exclusions include high suicidality, current dietary modification programs, certain other mental disorders, adequate omega-3 levels, high vitamin D intake, recent med changes, or severe food allergies.Check my eligibility
What is being tested?
The trial is testing if dietary counselling combined with Omega-3 supplements can help women with generalized anxiety disorder. It's randomized: half start the treatment immediately for 12 weeks; the other half wait before starting. The study checks how practical and acceptable this approach is.See study design
What are the potential side effects?
Potential side effects from Omega-3 supplements may include fishy aftertaste, upset stomach or nausea. Dietary changes could also cause digestive adjustments depending on individual tolerance to new foods.
EASe-GAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Interventional procedure
Interventional procedure
Secondary outcome measures
Anxiety
C-reactive protein
Diet Quality: MEDI-LITE Questionnaire
+9 moreEASe-GAD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate StartExperimental Treatment1 Intervention
Dietary Counselling (7 bi-weekly sessions) plus omega-3 supplementation
Group II: Waitlist ControlActive Control1 Intervention
Participants will wait 12 weeks and then complete the same intervention as the Immediate Start arm.
Find a Location
Who is running the clinical trial?
AquaOmegaUNKNOWN
Massachusetts General HospitalOTHER
2,945 Previous Clinical Trials
13,203,828 Total Patients Enrolled
11 Trials studying Generalized Anxiety Disorder
1,082 Patients Enrolled for Generalized Anxiety Disorder
Lipid Analytical Laboratories IncUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently experiencing thoughts of self-harm or suicide, as determined by a psychiatrist using a specific assessment tool called the Columbia Suicide Severity Scale.You can swallow pills.You are a woman between the ages of 18 and 65.You have significant anxiety, as determined by a score of 22 or higher on the Beck Anxiety Inventory.You have taken more than 4000IU of vitamin D every day for at least one month in the past six months.You are allergic to fish or any of the other ingredients in the study product.You have high levels of anxiety, as measured by a test called the Beck Anxiety Inventory, with a score of 22 or higher.You have a poor diet, which means you score 8.5 or less on the MEDI-LITE tool.You can easily swallow pills or capsules.You have a poor-quality diet, which means you score 8.5 or less on the MEDI-LITE tool.You have severe food allergies or aversions that would make it difficult for you to adjust your diet, including an aversion to bovine gelatin found in the fish oil supplement.
Research Study Groups:
This trial has the following groups:- Group 1: Waitlist Control
- Group 2: Immediate Start
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Generalized Anxiety Disorder Patient Testimony for trial: Trial Name: NCT05573672 — Phase 2
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