Clinical trial NCT05573672: Dietary Counselling Plus Omega-3 Supplementation in the Treatment of Generalized Anxiety Disorder
Official title: Dietary Counselling Plus Omega-3 Supplementation in the Treatment of Generalized Anxiety Disorder: A Randomized Wait-list Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Generalized Anxiety Disorder
Keywords: anxiety
generalized anxiety disorder
nutrition
diet
omega-3
lifestyle
Lead sponsor: The Canadian College of Naturopathic Medicine
Sponsor class: OTHER
Collaborators: name: McGill University
name: Netherlands Open University
name: Massachusetts General Hospital
name: Ekhagastiftelsen
name: AquaOmega
name: Lipid Analytical Laboratories Inc
name: Mitacs
First posted: 2022-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be wait-list controlled. Participants will be randomized to one of two groups. One group will begin the intervention immediately. The other will wait 12 weeks and then complete the intervention.
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Feasibility of Participant Recruitment and Intervention Delivery
timeFrame: 8 months
measure: Acceptability of the Intervention by Study Participants
timeFrame: 12 weeks
Secondary outcomes:
measure: Anxiety Symptom Severity: The Beck Anxiety Inventory
timeFrame: 12 weeks
measure: Diet Quality: MEDI-LITE Questionnaire
timeFrame: 12 weeks
measure: Quality of Life: PROMIS-29 v2.1
timeFrame: 12 weeks
measure: Mindful Eating Behaviour: Mindful Eating Questionnaire
timeFrame: 12 weeks
measure: Self Efficacy: General Self-Efficacy Scale
timeFrame: 12 weeks
measure: OmegaScore
timeFrame: 12 weeks
measure: Fasting Cholesterol Panel
timeFrame: 12 weeks
measure: Hemoglobin A1c
timeFrame: 12 weeks
measure: Serum Vitamin C
timeFrame: 12 weeks
measure: Serum Beta-carotene
timeFrame: 12 weeks
measure: C-reactive Protein
timeFrame: 12 weeks
measure: HOMA-IR
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Canadian College of Naturopathic Medicine
state: Ontario
Study officials:
affiliation: Canadian College of Naturopathic Medicine
name: Monique Aucoin, ND MSc
role: PRINCIPAL_INVESTIGATOR
References: