Gallant Faith, Cooley Kieran, Grigoriadis Sophie, Ebrahimi Neda
Rehabilitation Nevena Christina Case Management and Occupational Therapy Services (NCCO), Toronto, ON, Canada.
Department of Research and Clinical Epidemiology, Canadian College of Naturopathic Medicine (CCNM), Toronto, ON, Canada.
Front Psychiatry. 2024 Aug 7;15:1414291. doi: 10.3389/fpsyt.2024.1414291. eCollection 2024.
Perinatal depression and anxiety (PDA) is prevalent in new and expectant mothers, affecting millions of women worldwide. Those with a history of mood and anxiety disorders are at the greatest risk of experiencing PDA in a subsequent pregnancy. Current safety concerns with pharmacological treatments have led to a greater need for adjunctive treatment options for PDA. Changes in the composition of the microbiome have been associated with various diseases during pregnancy, and these changes are thought to play some role in perinatal mood disorders. While the relationship between PDA and the microbiome has not been explored, evidence suggests that nutritional interventions with fiber, fish oils, and probiotics may play a favorable role in neuropsychiatric outcomes during and after pregnancy. The primary objective of the present study is to assess the feasibility and acceptability of a combination of nonpharmacological interventions to maintain stability in pregnant women who have a history of depression and/or anxiety. This study will also aim to understand ease of recruitment and protocol adherence in this cohort.
This is a single-centered, partially randomized, placebo-controlled, double-blind feasibility trial. One hundred pregnant women with a history of depression and/or anxiety/PDA will be recruited and randomized into one of four arms, which could include the following: receiving a daily dose of both investigational products and dietary counseling on increasing dietary fiber, receiving a daily dose of both investigational drugs only, receiving fish oil investigational product and placebo, and a control arm with no intervention. The study involves six study visits, all of which can be conducted virtually every 3 months from the time of enrollment. At all study visits, information on diet, mental health, physical activity, and sleep quality will be collected. Additionally, all participants will provide a stool sample at each visit.
It is anticipated that pregnant women with a history of depression and anxiety will be particularly interested in partaking in this trial, resulting in favorable recruitment rates. Given the positive findings of omega-3 fatty acids (O3FAs) and probiotic supplements on mental health symptoms in nonpregnant adults, we expect a similar trend in PDA symptoms, with a low likelihood of adverse events. This study will build the foundation for larger powered studies to further contribute evidence for the efficacy of this potential preventative treatment option.
This trial was registered at ClinicalTrials/gov on October 6, 2023; NCT06074250. Trial Sponsor: The Canadian College of Naturopathic Medicine, 1255 Sheppard Ave E, Toronto, ON M2K 1E2, 416-498-1255.
围产期抑郁和焦虑（PDA）在初为人母和准妈妈中很普遍，影响着全球数百万女性。有情绪和焦虑障碍病史的女性在后续怀孕时患PDA的风险最大。目前对药物治疗安全性的担忧导致对PDA辅助治疗方案的需求更大。微生物群组成的变化与孕期各种疾病有关，这些变化被认为在围产期情绪障碍中起一定作用。虽然尚未探讨PDA与微生物群之间的关系，但有证据表明，纤维、鱼油和益生菌的营养干预可能对孕期及产后的神经精神结局起到有益作用。本研究的主要目的是评估非药物干预组合对有抑郁和/或焦虑病史的孕妇维持情绪稳定的可行性和可接受性。本研究还旨在了解该队列中招募的难易程度和方案依从性。
这是一项单中心、部分随机、安慰剂对照、双盲可行性试验。将招募100名有抑郁和/或焦虑/PDA病史的孕妇，并随机分为四组之一，可能包括：每日服用两种研究产品并接受增加膳食纤维的饮食咨询；仅每日服用两种研究药物；服用鱼油研究产品和安慰剂；以及不进行干预的对照组。该研究包括六次研究访视，从入组时起每3个月均可通过虚拟方式进行。在所有研究访视中，将收集饮食、心理健康、身体活动和睡眠质量方面的信息。此外，所有参与者每次访视时都将提供一份粪便样本。
预计有抑郁和焦虑病史的孕妇会对参与本试验特别感兴趣，从而获得良好的招募率。鉴于ω-3脂肪酸（O3FAs）和益生菌补充剂对非孕妇心理健康症状的积极研究结果，我们预计PDA症状也会有类似趋势，且不良事件发生可能性较低。本研究将为更大规模的研究奠定基础，以进一步为这种潜在预防治疗方案的疗效提供证据。
本试验于2023年10月6日在ClinicalTrials/gov注册；NCT06074250。试验主办方：加拿大自然疗法医学院，多伦多市谢泼德大道东1255号，安大略省M2K 1E2，电话416 - 498 - 1255。
