Dietary Counselling Plus Omega-3 Supplementation in the Treatment of Generalized Anxiety Disorder: A Randomized Wait-list Controlled Pilot Trial

Status: Completed
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• 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

Locations
Other Locations
Canada
Canadian College of Naturopathic Medicine
Toronto
Time Frame
Start Date: 2022-08-12
Completion Date: 2023-11-30
Participants
Target number of participants: 50
Treatments
Experimental: Immediate Start
Dietary Counselling (7 bi-weekly sessions) plus omega-3 supplementation
No_intervention: Waitlist Control
Participants will wait 12 weeks and then complete the same intervention as the Immediate Start arm.
Related Therapeutic Areas
Sponsors
Collaborators: Mitacs, McGill University, Massachusetts General Hospital, AquaOmega, Netherlands Open University, Ekhagastiftelsen, Lipid Analytical Laboratories Inc
Leads: The Canadian College of Naturopathic Medicine

This content was sourced from clinicaltrials.gov

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