Nutritional Intervention With Mediterranean Diet in the Prevention of Recurrence of Depression
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 750
- 主要终点
- Time until recurrence of depression (defined as a clinical diagnosis of unipolar depressive disorder made by a Psychiatrist from the research team)
研究概览
简要总结
OBJECTIVES:To assess the effect of the intervention with Mediterranean Diet (MD) supplemented with extra virgin olive oil (EVOO) or tree nuts (TN) during 2 years (compared to a control group without intervention) on the risk of recurrence of unipolar depressive disorder in patients with partial or total remission for unipolar depressive disorder (1). Differences between groups in changes in residual symptoms (2), quality of life (QL) (3), biochemical parameters (4) and in the risk of medical/psychiatric co-morbidities (5) will be also analyzed. Finally, gut microbiota and its changes will be collected and compared between groups (6). METHODS: Multicenter clinical trial with 3 arms of intervention (MD+EVOO; MD+TN;control) during 2 years. Adults with previous episodes of unipolar depressive disorder in partial or total remission stage (determined through Montgomery-Asberg questionnaire and MINI interview) will be included. Participants with current depression, psychiatric co-morbid disorders or with problems to follow dietary recommendations will be excluded. A recurrence ratio of 35% in the MD groups and of 50% in the control group will be considered (Hazard Ratio: 0.7). We estimate a sample size of 720 participants (750 to count for losses) (90% power and 5% alpha error). Intervention will be performed through postal mail (recipes and information), email, phone y new technologies (Web page/mobile app) with periodic contacts with psychiatrics and dieticians and postal mail for free EVOO and nuts supply. Information from participants will be gathered with validated questionnaires of diet, physical activity, QL, or symptoms using postal mail, email, Web page or the phone. The analyses will be performed by intention to treat.
详细描述
DESIGN This trial is a multicenter, parallel clinical trial with 3 intervention arms, two of them with Mediterranean Diet (MD) supplemented extra virgin olive oil (EVOO) or tree nuts (TN) and the last one is the control group without any kind of nutritional intervention.
SAMPLE Seven groups across Spain have agreed to participate in the trial and will recruit participants. With a 5% alpha error, 90% power and considering an incidence of recurrence of depression after 2 years of intervention of 35% in the MD groups and of 50% in the control group, we will need 240 participants in each group. Considering also possible losses, finally we have estimated a sample size of 750 participants, 108 participants in each of the recruitment centers.
The inclusion criteria were defined after an exhaustive review of the scientific literature and under consensus among all the psychiatric and clinical psychologists included in the study. We will include 1 participant with a unique episode of depression for each three participants with 2 or more episodes.
SELECTION OF PARTICIPANTS Clinical psychologists and psychiatrists will carry out the pre-selection of the participants after a detailed review of their clinical records. When a participant is pre-selected, the psychiatrists will perform a semi-structured interview (MINI interview) according to DSM-V criteria and a Montgomery-Asberg Depression Rating Scale to discard depression and other mental disorders diagnoses and to assess depression remission degree. This information will be completed with some questions included in the eligibility questionnaire such as medical conditions or problems related with the adherence to the MD. Moreover, participants will receive detailed written information of the study and the informed consent that they have to sign. The nurse will perform a venipuncture to obtain a blood sample according to the normal protocol. Moreover, in a subsample of the sample the participants will be instructed to collect a stool sample. Finally, all the data will be transferred to the dietitians of the study.
The dietitians of the study will be responsible for the periodic contact with the participants and to perform the nutritional intervention and follow-up. Contacts will be made through new technologies such as a web platform, a mobile app, telephone and email. Additionally, if a participant is not familiarized with these technologies, the dieticians will use postal mail to send all the information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with a previous diagnosis of depression in the last 5 years and in a stage of total or partial remission
排除标准
- •presence of comorbid psychiatric disorders (anxiety, bipolar disorder, personality disorders, alcohol and drug abuse, mania, psychosis)
- •presence of severe medical condition with survival lower than one year)
- •history of food allergy with hypersensitivity to any of the components of olive oil or nuts
- •presence of disorders of chewing or swallowing
- •difficulties to change dietary habits
- •institutionalized patients and those participants who lack autonomy
结局指标
主要结局
Time until recurrence of depression (defined as a clinical diagnosis of unipolar depressive disorder made by a Psychiatrist from the research team)
时间窗: From date of randomization until the date of first documented depressive episode diagnosis assessed up to 32 months
New diagnoses of episodes of depression (recurrent depression as participants have a history of unipolar depressive disorder).
次要结局
- Change in depressive symptoms using the Montgomery Asberg Depression Rating Scale(Yearly (baseline, 1-year, 2-year of follow-up))
- Change in quality of life using the SF-36 quality of life questionnaire(Yearly (baseline, 1-year, 2-year of follow-up))
- Change in biochemical parameters (plasma levels of total cholesterol, HDL-cholesterol, LDL-cholesterol, glucose, protein C Reactive)(Yearly (baseline, 1-year, 2-year of follow-up))
- Change in microbiota in stool samples(Change from baseline to the second year of follow-up)
- Incidence of physical diseases (Clinically confirmed after an exhaustive review of clinical records of the participants)(From date of randomization until the date of first documented physical disease diagnosis assessed up to 32 months)
- Incidence of other psychiatric disorders (clinical diagnosis made by a Psychiatrist from the research team)(From date of randomization until the date of first documented psychiatric disorder diagnosis assessed up to 32 months)
研究者
Almudena Sanchez-Villegas
Professor of Preventive Medicine
University of Las Palmas de Gran Canaria