Study 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.
Eligible Conditions
- Generalized Anxiety Disorder
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 12 Secondary · Reporting Duration: 2 years
2 years
Interventional procedure
Anxiety
C-reactive protein
Diet Quality: MEDI-LITE Questionnaire
Fasting Cholesterol Panel
Interventional procedure
HOMA-IR
Glycosylated hemoglobin A
Mindful Eating Behaviour: Mindful Eating Questionnaire
OmegaScore
Quality of Life: PROMIS-29 v2.1
Self Efficacy: General Self-Efficacy Scale
Beta carotene
Serum Vitamin C
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Waitlist Control
1 of 2
Immediate Start
1 of 2
Active Control
Experimental Treatment
50 Total Participants · 2 Treatment Groups
Primary Treatment: Immediate Start · No Placebo Group · Phase 2
Immediate Start
CombinationProduct
Experimental Group · 1 Intervention: Dietary Counselling combined with Omega-3 Supplementation · Intervention Types: CombinationProductWaitlist ControlNoIntervention Group · 1 Intervention: Waitlist Control · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Who is running the clinical trial?
AquaOmegaUNKNOWN
Massachusetts General HospitalOTHER
2,703 Previous Clinical Trials
30,853,158 Total Patients Enrolled
10 Trials studying Generalized Anxiety Disorder
1,004 Patients Enrolled for Generalized Anxiety Disorder
Lipid Analytical Laboratories IncUNKNOWN
EkhagastiftelsenOTHER
7 Previous Clinical Trials
948 Total Patients Enrolled
MitacsIndustry Sponsor
29 Previous Clinical Trials
3,845 Total Patients Enrolled
Netherlands Open UniversityOTHER
1 Previous Clinical Trials
568 Total Patients Enrolled
The Canadian College of Naturopathic MedicineLead Sponsor
19 Previous Clinical Trials
2,381 Total Patients Enrolled
McGill UniversityOTHER
359 Previous Clinical Trials
976,767 Total Patients Enrolled
Monique Aucoin, ND MScPrincipal InvestigatorCanadian College of Naturopathic Medicine
Eligibility Criteria
Age 18 - 65 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have been diagnosed by a psychiatrist, based on the DSM-5 criteria, with generalized anxiety disorder through an in-person clinical interview.
You experience moderate to severe anxiety, as indicated by a Beck Anxiety Inventory score of 22 or greater.
Your diet is classified as suboptimal according to MEDI-LITE scores.
You have had a consistent regimen of psychiatric medication, psychotherapy and natural health products for the past four weeks.
You have a long-standing therapeutic relationship with your primary mental health care provider, such as a family physician, psychiatrist or psychologist.
You can ingest capsules.
You are able to read in English and grant informed consent.
You are between 18 and 65 years of age, and identify as female.
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Conditions
Cancer Related
Treatments