Department of Psychology, University of California, Berkeley, CA, USA.
Centre for Mental Health, Swinburne University, Melbourne, VIC, 3122, Australia.
BMC Psychiatry. 2024 Oct 21;24(1):711. doi: 10.1186/s12888-024-06157-5.
The primary objective of this trial is to examine the mechanisms of time-restricted eating (TRE) as an adjunct to psychiatric care for people with bipolar disorder (BD) with sleep or circadian disruptions. This study builds on prior studies of circadian disruption in BD as well as growing evidence that TRE improves circadian functioning.
One-hundred fifty participants diagnosed with BD 1 or II will be recruited via advertising in the local community. Main inclusion criteria include: obtaining medical treatment for BD; current sleep or circadian problems; self-reported eating period of ≥ 12 h; no eating disorder or other health conditions that would hinder or limit the safety of following TRE; and not currently experiencing a mood episode, acute suicidality, psychosis, alcohol or substance use disorder. Participants will be asked to complete a baseline period in which daily food intake is logged online for two weeks. After baseline, participants will be asked to follow TRE for 8 weeks and to continue to complete daily food logging during this time. Symptom severity interviews will be conducted by phone or videoconference at baseline, mid-intervention (6 weeks post-baseline), end of intervention (10 weeks post-baseline), and 6 months post-baseline. Self-rated symptom severity and quality of life data will be gathered online at the same time points as symptom severity interviews, and at 16 weeks post-baseline (6 weeks after the TRE period ends). To assess potential mechanisms of change, we will examine the change in diurnal amplitude of 'clock' gene expression as a primary mediator at 8 weeks compared to baseline. We will further test whether diurnal amplitude of clock gene expression is predictive above and beyond the role of two covariate potential mediators, glucose tolerance and inflammation at 8 weeks relative to baseline. To provide an index of whether TRE successfully decreases emotional lability, participants will be asked to complete 5 mood assessments per day for 7 days at baseline and at 10 weeks. These mood assessments will be optional.
The planned research will provide novel and important information on whether TRE improves sleep/circadian rhythm problems, along with reductions in mood symptoms and improvements in quality of life, for individuals with BD.
ClinicalTrials.gov ID: NCT06555406.
本试验的主要目的是研究限时进食（TRE）作为双相障碍（BD）伴睡眠或昼夜节律紊乱患者精神科治疗辅助手段的作用机制。本研究建立在之前关于 BD 昼夜节律紊乱的研究以及越来越多的证据基础上，这些证据表明 TRE 可改善昼夜节律功能。
通过在当地社区做广告，将招募 150 名被诊断为 BD1 或 BD2 的参与者。主要纳入标准包括：接受 BD 治疗；目前存在睡眠或昼夜节律问题；自我报告的进食时间≥12 小时；无饮食障碍或其他健康状况会妨碍或限制 TRE 的安全性；且目前无心境发作、急性自杀意念、精神病、酒精或物质使用障碍。参与者将被要求完成基线期，在此期间需要在线记录两周内的每日食物摄入量。基线期过后，参与者将被要求进行 8 周的 TRE，并在此期间继续完成每日食物记录。在基线期、中期干预（基线后 6 周）、干预结束（基线后 10 周）和基线后 6 个月将通过电话或视频会议进行症状严重程度访谈。自我报告的症状严重程度和生活质量数据将在与症状严重程度访谈相同的时间点以及基线后 16 周（TRE 结束后 6 周）在线收集。为了评估潜在的变化机制，我们将在 8 周时作为主要中介物，评估“时钟”基因表达的昼夜振幅变化。我们将进一步测试昼夜振幅的时钟基因表达是否在 8 周时相对于基线，超过了两个潜在协变量中介物（葡萄糖耐量和炎症）的作用，具有预测性。为了提供 TRE 是否成功降低情绪波动性的指标，在基线期和 10 周时，参与者将被要求每天完成 5 次情绪评估，共 7 天。这些情绪评估是可选的。
计划中的研究将为 TRE 是否可改善 BD 患者的睡眠/昼夜节律问题以及减轻情绪症状和提高生活质量提供新的和重要的信息。
ClinicalTrials.gov 注册号：NCT06555406。
