Dietary Counselling Plus Omega-3 Supplementation in the Treatment of Generalized Anxiety Disorder (EASe-GAD)

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

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Monique Aucoin, ND MSc
  • Phone Number: 223 416 498 1255
  • Email: maucoin@ccnm.edu

Study Contact Backup

  • Name: Kieran Cooley, ND
  • Phone Number: 324 416 498 1255
  • Email: kcooley@ccnm.edu

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M2K 1E2
        • Canadian College of Naturopathic Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Start
Dietary Counselling (7 bi-weekly sessions) plus 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.

No Intervention: Waitlist Control
Participants will wait 12 weeks and then complete the same intervention as the Immediate Start arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of participant recruitment and intervention delivery
Time Frame: 2 years
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
Acceptability of the intervention by study participants
Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Symptom Severity: The Beck Anxiety Inventory
Time Frame: 2 years
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
Diet Quality: MEDI-LITE Questionnaire
Time Frame: 2 years
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
Quality of Life: PROMIS-29 v2.1
Time Frame: 2 years
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
Mindful Eating Behaviour: Mindful Eating Questionnaire
Time Frame: 2 years
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
Self Efficacy: General Self-Efficacy Scale
Time Frame: 2 years
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
OmegaScore
Time Frame: 2 years
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
Fasting Cholesterol Panel
Time Frame: 2 years
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
Hemoglobin A1c
Time Frame: 2 years
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
Serum Vitamin C
Time Frame: 2 years
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
Serum Beta-carotene
Time Frame: 2 years
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
C-reactive protein
Time Frame: 2 years
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
HOMA-IR
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Monique Aucoin, ND MSc, Canadian College of Naturopathic Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2022

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

October 4, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCNM_EASe-GADCT_2201v3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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