Phase 2
N=50
Dietary Counselling Plus Omega-3 Supplementation in the Treatment of Generalized Anxiety Disorder
Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05573672 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Feasibility of Participant Recruitment and Intervention Delivery — 8; 8 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dietary Counselling combined with Omega-3 Supplementation (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Canadian College of Naturopathic Medicine
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Participant Recruitment and Intervention Delivery |
8; 8 | — |
| PRIMARY Acceptability of the Intervention by Study Participants |
6.4; 6.4 | — |
| SECONDARY Anxiety Symptom Severity: The Beck Anxiety Inventory |
26.2; 29.3; 11.0; 26.8 | — |
| SECONDARY Diet Quality: MEDI-LITE Questionnaire |
7.2; 7.1; 10.5; 6.9 | — |
| SECONDARY Quality of Life: PROMIS-29 v2.1 |
4.54; 4.28; 4.79; 4.20; 3.42; 3.55 | — |
| SECONDARY Mindful Eating Behaviour: Mindful Eating Questionnaire |
2.5; 2.6; 2.88; 2.5 | — |
| SECONDARY Self Efficacy: General Self-Efficacy Scale |
28.9; 28.2; 32.3; 28.2 | — |
| SECONDARY OmegaScore |
3.58; 3.43; 7.18; 3.47 | — |
| SECONDARY Fasting Cholesterol Panel |
1.13; 1.02; 0.88; 0.88; 4.72; 4.80 | — |
| SECONDARY Hemoglobin A1c |
5.35; 5.52; 5.36; 5.57 | — |
| SECONDARY Serum Vitamin C |
49.00; 41.36; 50.90; 42.25 | — |
| SECONDARY Serum Beta-carotene |
0.53; 0.40; 0.66; 0.44 | — |
| SECONDARY C-reactive Protein |
3.11; 6.60; 4.06; 7.49 | — |
| SECONDARY HOMA-IR |
2.94; 4.05; 2.92; 4.81 | — |
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 Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Currently meets DSM-5 criteria for obsessive-compulsive disorder, bipolar disorder, a psychotic disorder, an eating disorder, or substance use disorder based on clinical interview with a psychiatrist.
- Current high level of suicidality assessed by trial psychiatrist using the Columbia Suicide Severity Scale.
- Starting or changing the dose of a psychiatric medication, psychotherapy, or natural health products in the past four weeks.
- Severe food allergies, intolerances or aversions that would prevent the individual from modifying their diet (includes aversion to bovine gelatin which is a component of the fish oil supplement).
- Current participation in a program, research study or treatment plan involving diet or lifestyle modification.
- Baseline Omega Score of >5% (suggesting adequacy of omega-3 fatty acids).
- Supplementation of greater than 4000IU of vitamin D daily for at least one month in the previous six months.
- Allergy to fish or any of the non-medicinal ingredients in the study product.
Data sourced from ClinicalTrials.gov (NCT05573672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.