Dietary Counselling Plus Omega-3 Supplementation in the Treatment of Generalized Anxiety Disorder: A Randomized Wait-list Controlled Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility of Participant Recruitment and Intervention Delivery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Collection of height and weight data will be completed by an individual blind to participant allocation. The statistician completing data analysis will be blind to allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Feasibility of Participant Recruitment and Intervention Delivery
时间窗: 8 months
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.
Acceptability of the Intervention by Study Participants
时间窗: 12 weeks
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.
次要结局
- Self Efficacy: General Self-Efficacy Scale(12 weeks)
- Anxiety Symptom Severity: The Beck Anxiety Inventory(12 weeks)
- Diet Quality: MEDI-LITE Questionnaire(12 weeks)
- Quality of Life: PROMIS-29 v2.1(12 weeks)
- Mindful Eating Behaviour: Mindful Eating Questionnaire(12 weeks)
- OmegaScore(12 weeks)
- Fasting Cholesterol Panel(12 weeks)
- Hemoglobin A1c(12 weeks)
- Serum Vitamin C(12 weeks)
- Serum Beta-carotene(12 weeks)
- C-reactive Protein(12 weeks)
- HOMA-IR(12 weeks)