Dietary Counselling Plus Omega-3 Supplementation in the Treatment of Generalized Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

— EASe-GAD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05573672
• Other study ID #: CCNM_EASe-GADCT_2201v3
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 12, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: August 2023
• Source: The Canadian College of Naturopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Generalized Anxiety Disorder (GAD) is a common mental health disorder involving high levels of worry or tension. The symptoms are persistent and distressing and interfere with an individual's functioning and quality of life. Clinical evidence suggests that nutritional interventions, based on the Mediterranean diet and omega-3 fatty acid supplementation improve the symptoms of depression. To date, the effect of diet change interventions on anxiety symptoms has not been studied in trials involving people with diagnosed anxiety disorders. The primary objective of this study is to test the feasibility and acceptability of a dietary counselling and omega-3 fatty acid supplementation intervention delivered to adult women with GAD. The secondary objectives include measuring changes in anxiety symptom severity, measuring changes in quality of life, measuring changes in biomarkers and evaluation of the components of the program. This study is a randomized, wait-list controlled pilot trial delivering a 12-week, dietary counselling intervention and omega-3 supplementation to 50 adult women with GAD. Participant will complete seven individual counselling sessions which include nutrition education, personalized recommendations, mindful eating techniques, motivational interviewing, and goal setting. They will be provided with recipes, instructional videos, and food items. Questionnaires and blood work will be completed at baseline, after the wait period (for those in the wait-list group) and after the intervention. The questionnaires will measure changes in anxiety symptom severity, quality of life, diet quality, mindful eating behaviours, and self-efficacy and lab tests will measure changes in biomarkers of nutritional status. All participants will be asked to complete a brief satisfaction survey concerning the participant's level of satisfaction with the program, the aspects which were helpful or unhelpful, and opportunities for improvement. A sub-sample will be recruited to participate in a brief focus group in order to obtain more detailed qualitative responses about the participant experience and participant satisfaction. Additional information will be collected to characterize study participants including demographic information, body mass index, physical activity and food security. Results from this study will lay the foundation for future large-scale studies in this area and may provide preliminary evidence of the role of diet counselling and omega-3 supplementation in the management of GAD.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Combination Product:
• Dietary Counselling combined with Omega-3 Supplementation
Dietary Counselling: Seven, bi-weekly counselling sessions over 12-weeks conducted by a licensed Naturopathic Doctor. Each session will be 45-60 minutes in length. The recommendations will be based on the Mediterranean diet and the results of a recent scoping review which summarized the research related to diet and anxiety. The intervention will include motivational interviewing, mindful eating techniques, goal setting and action planning. A range of resources related to meal planning, recipes, cooking education, shopping lists and tracking sheets will be provided in an individualized manner. Dietary Supplement: AquaOmega High EPA Omega-3 capsules will be taken at a dose of four capsules, once daily (containing a total of 3456 mg of omega-3 fatty acids: 2659mg of Eicosapentaenoic acid (EPA), 532mg of docosahexaenoic acid (DHA), and 800IU of Vitamin D), with a meal.

Locations

Country	Name	City	State
Canada	Canadian College of Naturopathic Medicine	Toronto	Ontario

Sponsors (8)

Lead Sponsor	Collaborator
The Canadian College of Naturopathic Medicine	AquaOmega, Ekhagastiftelsen, Lipid Analytical Laboratories Inc, Massachusetts General Hospital, McGill University, Mitacs, Netherlands Open University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of participant recruitment and intervention delivery	Feasibility will be assessed by measuring the time to recruit and enrol 50 participants. Additionally, we will compare the intervention protocol with the intervention activities delivered.	2 years
Primary	Acceptability of the intervention by study participants	Acceptability will be assessed by measuring the number of diet counselling sessions completed. Additionally, participants will be asked to complete a brief satisfaction survey concerning the participant's level of satisfaction with the program, the aspects which were helpful or unhelpful, and opportunities for improvement. A sub-sample will be recruited to participate in a brief focus group in order to obtain more detailed qualitative responses about the participant experience and participant satisfaction.	2 years
Secondary	Anxiety Symptom Severity: The Beck Anxiety Inventory	The Beck Anxiety Inventory is a validated 21-item self-report inventory for measuring the severity of anxiety in participants with psychiatric illness. Answers to each item are given a score of 0 (not at all), 1 (mild), 2 (moderate) or 3 (severely), total scores range from 0 to 63 (minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63)). The Beck Anxiety Inventory will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.	2 years
Secondary	Diet Quality: MEDI-LITE Questionnaire	MEDI-LITE is a validated questionnaire that measures daily and weekly consumption of food typical and non-typical to the Mediterranean diet. Typical Mediterranean diet foods are scored 2 for high consumption, 1 more moderate and 0 for low. Non-typical Mediterranean diet foods are scored 2 for low consumption, 1 for moderate and 0 for high. Scores range from 0 (low consumption) to 18 (high consumption). The MEDI-LITE questionnaire will be completed to assess adherence to the Mediterranean diet at baseline, after the wait period (for those in the waitlist group) and after the intervention.	2 years
Secondary	Quality of Life: PROMIS-29 v2.1	The PROMIS-29 is a validated scale using 4 items scored on a 1-5 scale on intensity to assess 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities and pain interference). PROMIS-29 will be used to assess quality of life at baseline, after the wait period (for those in the waitlist group) and after the intervention.	2 years
Secondary	Mindful Eating Behaviour: Mindful Eating Questionnaire	The MEQ is a 28-item scale that measures five factors associated with mindful eating (emotional responses, distraction, external cues, awareness and disinhibition). The questionnaire will be used to measure behaviour change and qualitatively assess the acceptability of the intervention. Each item is scored on a 1-4 scale, higher scores signify more mindful eating. The MEQ will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.	2 years
Secondary	Self Efficacy: General Self-Efficacy Scale	The GSE is a 10-item validated questionnaire that measures an individual's belief in their ability to overcome and respond to difficult scenarios. Answers to each item are given a score of 0 (not at all true), 1 (barely true), 3 (moderately true) or 4 (exactly true), higher scores correlate to greater self-efficacy. The GSE will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.	2 years
Secondary	OmegaScore	Summed EPA, DHA and DPA as a percentage of total fatty acids in whole blood as a measure of omega-3 status. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.	2 years
Secondary	Fasting Cholesterol Panel	Measures of serum cholesterol including LDL, HDL, triglycerides and total cholesterol. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.	2 years
Secondary	Hemoglobin A1c	Measure of the average blood sugar in the past 3 months. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.	2 years
Secondary	Serum Vitamin C	Measure of serum levels of vitamin C as an objective marker for fruit and vegetable intake. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.	2 years
Secondary	Serum Beta-carotene	Measure of serum levels of beta-carotene as an objective marker for fruit and vegetable. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.	2 years
Secondary	C-reactive protein	CRP will be used to measure inflammation levels. This blood test will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.	2 years
Secondary	HOMA-IR	Homeostatic Model Assessment of Insulin Resistance, calculated using fasting insulin and fasting glucose. These blood tests and calculation will be completed at baseline, after the wait period (for those in the waitlist group) and after the intervention.	2 years

External Links

•   Pre-print of study protocol