Department of Psychology, University of California, Berkeley, USA.
Centre for Mental Health, Swinburne University, Melbourne, VIC, 3122, Australia.
BMC Psychiatry. 2024 May 18;24(1):374. doi: 10.1186/s12888-024-05790-4.
The primary objective of this randomized controlled trial (RCT) is to establish the effectiveness of time-restricted eating (TRE) compared with the Mediterranean diet for people with bipolar disorder (BD) who have symptoms of sleep disorders or circadian rhythm sleep-wake disruption. This work builds on the growing evidence that TRE has benefits for improving circadian rhythms. TRE and Mediterranean diet guidance will be offered remotely using self-help materials and an app, with coaching support.
This study is an international RCT to compare the effectiveness of TRE and the Mediterranean diet. Three hundred participants will be recruited primarily via social media. Main inclusion criteria are: receiving treatment for a diagnosis of BD I or II (confirmed via DIAMOND structured diagnostic interview), endorsement of sleep or circadian problems, self-reported eating window of ≥ 12 h, and no current mood episode, acute suicidality, eating disorder, psychosis, alcohol or substance use disorder, or other health conditions that would interfere with or limit the safety of following the dietary guidance. Participants will be asked to complete baseline daily food logging for two weeks and then will be randomly allocated to follow TRE or the Mediterranean diet for 8 weeks, during which time, they will continue to complete daily food logging. Intervention content will be delivered via an app. Symptom severity interviews will be conducted at baseline; mid-intervention (4 weeks after the intervention begins); end of intervention; and at 6, 9, and 15 months post-baseline by phone or videoconference. Self-rated symptom severity and quality of life data will be gathered at those timepoints, as well as at 16 weeks post baseline. To provide a more refined index of whether TRE successfully decreases emotional lability and improves sleep, participants will be asked to complete a sleep diary (core CSD) each morning and complete six mood assessments per day for eight days at baseline and again at mid-intervention.
The planned research will provide novel and important information on whether TRE is more beneficial than the Mediterranean diet for reducing mood symptoms and improving quality of life in individuals with BD who also experience sleep or circadian problems.
ClinicalTrials.gov ID NCT06188754.
本随机对照试验（RCT）的主要目的是确定限时进食（TRE）与地中海饮食相比，对有睡眠障碍或昼夜节律睡眠-觉醒障碍的双相情感障碍（BD）患者的有效性。这项工作基于越来越多的证据，即 TRE 有益于改善昼夜节律。TRE 和地中海饮食指导将通过自助材料和应用程序远程提供，并提供教练支持。
这是一项比较 TRE 和地中海饮食有效性的国际性 RCT。将主要通过社交媒体招募 300 名参与者。主要纳入标准为：接受 BD I 或 II 型（通过 DIAMOND 结构化诊断访谈确认）的治疗，认可睡眠或昼夜节律问题，自我报告的进食窗口≥12 小时，并且没有当前的情绪发作、急性自杀意念、饮食障碍、精神病、酒精或物质使用障碍，或其他会干扰或限制遵循饮食指导的安全性的健康状况。参与者将被要求完成两周的基线每日食物记录，然后随机分配到遵循 TRE 或地中海饮食 8 周，在此期间，他们将继续完成每日食物记录。干预内容将通过应用程序提供。在基线时进行症状严重程度访谈；干预中期（干预开始后 4 周）；干预结束时；以及在基线后 6、9 和 15 个月通过电话或视频会议进行。在这些时间点收集自我报告的症状严重程度和生活质量数据，以及在基线后 16 周。为了更精细地评估 TRE 是否能成功降低情绪波动性并改善睡眠，参与者将被要求在基线和干预中期再次每天早上填写一份睡眠日记（核心 CSD），并每天完成六次情绪评估，共八天。
计划中的研究将提供关于 TRE 是否比地中海饮食更有益于减少 BD 患者的情绪症状和提高生活质量的新颖而重要的信息，这些患者也有睡眠或昼夜节律问题。
ClinicalTrials.gov ID NCT06188754。
