Time-Restricted Eating as an Adjunctive Intervention for Bipolar Disorder: Acceptability and Feasibility
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Acceptability as assessed using self-ratings on items designed for this study
研究概览
简要总结
This is a pilot trial to examine the acceptability and feasibility of time-restricted eating as an adjunct to medication treatment for bipolar disorder.
详细描述
Time-restricted eating (TRE) is a way of scheduling food intake that has been shown to improve circadian rhythms in animals and humans. TRE is based on animal and human science that shows that the timing of eating powerfully influences diurnal rhythms. Animal research has shown that feeding during sleep periods leads to a surge of norepinephrine, cortisol, wakefulness, and activity. Drawing on this, over a decade of studies have examined the impact of experimentally randomizing mice to time-restricted feeding during wake hours (vs. 24-hour ad libitum feeding). Importantly, caloric intake and other facets of diet were yoked for strict control. A consistent finding is that TRE had powerful benefits for circadian and metabolic indicators across studies,and more recent data also shows benefit for animal longevity.
Here, the investigators' goal is to extend this work to bipolar disorder (BD). More specifically, the investigators will gather data to examine the acceptability and feasibility of TRE among those who self-identify with bipolar disorder and who experience some problems with sleep, circadian rhythms, or schedules. The investigators will gather measures of mania, depression, sleep, and QOL, to provide preliminary evidence of change on these dimensions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •adults diagnosed with bipolar disorder and currently receiving medical care for their bipolar disorder.
- •Experiencing schedule/sleep or circadian problem in the past 3 months
- •Medication regimens stable for past month
- •Adequate English language skills for taking part in the program.
- •Living in California.
排除标准
- •Cognitive deficits (Screening OMC Test)
- •Current: psychosis, (hypo)mania, major depressive episode, substance/alcohol use disorders, eating disorder diagnoses or acute suicidal risk (MINI interview; see DSM5 TRE screening)
- •High scores (> 5) on the Screening Eating Disorder Examination Questionnaire
- •Current shift work
- •>5 kg weight change within 3 months
- •Pregnancy
- •Breastfeeding
- •Uncorrected hypo or hyperthyroidism
- •* diabetes type 1
- •Gastrointestinal conditions impairing nutrient absorption
- •Medications contraindicated for fasting, including clozapine, glucose-lowering medications, diabetes-related injections, requiring food early morning or late evening, corticosteroids.
结局指标
主要结局
Acceptability as assessed using self-ratings on items designed for this study
时间窗: Immediately post-treatment (10 weeks)
self-ratings of the acceptability of the intervention
Feasibility as assessed by percent of clients who complete the assessments and intervention
时间窗: Immediately post-treatment (10 weeks)
Percentage of clients who do not drop out of the trial. Drop out would be defined as not completing the TRE intervention, or failing to complete the end-of-treatment intervention.
次要结局
- Lower scores on two Patient Reported Outcome Measurement Information System (PROMIS) sleep scales(Change from baseline to immediately post-treatment (10 weeks))
- higher scores on Self-rated Quality of Life(Change from baseline to immediatly post-treatment (10 weeks))
- Lower Mania symptoms as assessed with the Patient Mania Questionnaire-9(Change from baseline to immediately post-treatment (10 weeks))
- Lower Depression symptoms as assessed with the Patient Health Questionnaire-9(Change from baseline to immediately post-treatment (10 weeks))