Dietary Counselling Plus Omega-3 Supplementation in the Treatment of Generalized Anxiety Disorder
- Conditions
- Generalized Anxiety Disorder
- Registration Number
- NCT05573672
- Lead Sponsor
- The Canadian College of Naturopathic Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria:<br><br> - A person aged 18-65 years who currently identifies as a woman.<br><br> - Primary diagnosis of generalized anxiety disorder based on a clinical interview with<br> a psychiatrist using the DSM-5 criteria.<br><br> - Moderate to severe anxiety as defined as a Beck Anxiety Inventory score of 22 or<br> higher.<br><br> - Low quality diet as defined as a score of 8.5 or less on the MEDI-LITE tool.<br><br> - All psychiatric medication, psychotherapy and natural health products stable for the<br> past four weeks.<br><br> - Established therapeutic relationship with a family doctor, psychiatrist, or clinical<br> psychologist as their primary source of mental health care.<br><br> - Ability to swallow capsules.<br><br> - Ability to read in English and provide informed consent<br><br>Exclusion Criteria:<br><br> - Currently meets DSM-5 criteria for obsessive-compulsive disorder, bipolar disorder,<br> a psychotic disorder, an eating disorder, or substance use disorder based on<br> clinical interview with a psychiatrist.<br><br> - Current high level of suicidality assessed by trial psychiatrist using the Columbia<br> Suicide Severity Scale.<br><br> - Starting or changing the dose of a psychiatric medication, psychotherapy, or natural<br> health products in the past four weeks.<br><br> - Severe food allergies, intolerances or aversions that would prevent the individual<br> from modifying their diet (includes aversion to bovine gelatin which is a component<br> of the fish oil supplement).<br><br> - Current participation in a program, research study or treatment plan involving diet<br> or lifestyle modification.<br><br> - Baseline Omega Score of >5% (suggesting adequacy of omega-3 fatty acids).<br><br> - Supplementation of greater than 4000IU of vitamin D daily for at least one month in<br> the previous six months.<br><br> - Allergy to fish or any of the non-medicinal ingredients in the study product.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility of participant recruitment and intervention delivery;Acceptability of the intervention by study participants
- Secondary Outcome Measures
Name Time Method Anxiety Symptom Severity: The Beck Anxiety Inventory;Diet Quality: MEDI-LITE Questionnaire;Quality of Life: PROMIS-29 v2.1;Mindful Eating Behaviour: Mindful Eating Questionnaire;Self Efficacy: General Self-Efficacy Scale;OmegaScore;Fasting Cholesterol Panel;Hemoglobin A1c;Serum Vitamin C;Serum Beta-carotene;C-reactive protein;HOMA-IR