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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
2,928 Previous Clinical Trials
13,198,305 Total Patients Enrolled
11 Trials studying Generalized Anxiety Disorder
1,052 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: Immediate Start
- Group 2: Waitlist Control
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum capacity of enrollments for this trial?
"Affirmative. According to clinicaltrials.gov, the research endeavour was first made available on August 12th 2022 and has been updated as of October 6th 2022. The study is enrolling 50 participants from a single medical centre."
Answered by AI
Is this study still actively recruiting participants?
"Clinicaltrials.gov indicates that this trial is open to new participants; it was first published on August 12th 2022 and subsequently updated on October 6th of the same year."
Answered by AI
Are participants over the age of 40 eligible for enrollment in this investigation?
"The minimum and maximum age for enrollment in this medical study is 18 and 65 years old, respectively, in agreement with the inclusion criteria."
Answered by AI
What are the key goals of this research endeavor?
"This research study, which should take two years to complete, will primarily track the acceptability of the intervention amongst patients. Secondary objectives include monitoring quality-of-life via PROMIS-29 v2.1, HOMA-IR levels measured by fasting insulin and glucose tests, as well as anxiety symptom severity tracked through the Beck Anxiety Inventory."
Answered by AI
Has Immediate Start successfully gained clearance from the FDA?
"Immediate Start has attained a safety rating of 2, as there is some clinical data attesting to its security but no evidence-based proof of efficacy."
Answered by AI
Does my profile meet the criteria to participate in this experiment?
"This experiment is seeking 50 participants with anxiety disorders, aged 18-65."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Pennsylvania
Florida
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
0
3+
What site did they apply to?
Canadian College of Naturopathic Medicine
Why did patients apply to this trial?
I like to do things holistically. If i can avoid medication, great.
PatientReceived 2+ prior treatments
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