Feasibility and Acceptability of Adjunctive Time Restricted Eating in Bipolar Disorder: A Pilot Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time to recruit all participants
研究概览
简要总结
Bipolar disorders (BD) are a group of complex disorders that impact mood, behaviour and cognition and are known to cause significant suffering and impairment. Circadian rhythm (your internal day/night "clock") disruption, which can involve changes in sleep-wake cycles, frequently occurs in BD. Both depression and mania are accompanied by circadian disruption. These disruptions are hypothesized to lead to mood worsening, metabolic dysfunction and inflammation. If circadian dysfunction plays a significant role in the symptoms and trajectory of BD, then treatment approaches that target these functions may lead to better outcomes. One such approach is dietary interventions. Time restricted eating (TRE) is a dietary tool that restricts the eating to an 8-12 hour window, without changing diet quality or caloric intake. Studies involving time restricted eating have been done in other conditions with promising results. There have been no studies done for mood disorders in general or bipolar disorder specifically. In this proposal, the investigators will assess two dietary interventions (TRE and nutritional counselling) to examine how TRE may represent a safe and viable adjunct to traditional treatments. The investigators aim to compare TRE with nutritional counselling, while all participants continue to receive usual care. Participants will receive support from a registered dietician and will be instructed on dietary habits. Half of participants will receive nutritional counselling and half will be asked to do TRE. Those in the TRE group will be asked to select a 10-hour window to consume all food and non-water beverages for the 8-week period. Participants will be asked to complete a screening visit to determine eligibility, and then will complete questionnaires at baseline, week 4 and week 8 examining symptoms of their illness and cognition. Participants will also provide a blood sample at baseline and week 8 for standard biochemistry tests, pregnancy testing (if applicable), and to examine inflammatory markers. Participants will also wear an actigraphy watch which provides wireless continuous monitoring of movements and ambient light. The primary outcome is feasibility and acceptability (do people agree to participate, complete the study, and follow the intervention; what do they think of the intervention). Secondary outcomes include changes in depression, anxiety, sleep, and cognition. Exploratory outcomes include inflammatory markers and circadian disruption.
详细描述
Given the lack of studies evaluating time restricted eating (TRE), this pilot study aims to examine the feasibility and acceptability of TRE as a prelude to a future multi-centre randomized controlled trial (RCT) evaluating efficacy. If adjunctive TRE is found to be feasible, this will pave the way for a novel and safe intervention which may have the potential to treat circadian dysfunction, metabolic side effects and improve mood and cognitive outcomes in patients with BD.
To evaluate the feasibility and acceptability of adjunctive 10-hour TRE with treatment as usual relative to nutritional counselling and treatment as usual for the treatment of depression associated with bipolar disorder. To do this, the investigators will estimate the rate (proportion) of eligible people who are willing to participate, participants who drop out of the trial and participants who adhere to their allocated intervention.
First, the investigators hypothesize that the investigators would achieve our recruitment target of 40 patients with BD within the study's 18-month duration and retain at least 70% of participants through the follow-up period to evaluate feasibility. The investigators will also be able to estimate what level of adherence could be expected following a single intervention with a 4-week reminder. Second, the investigators hypothesize that participants would complete the intervention and find it acceptable.
Secondary Objectives To assess if TRE leads to meaningful reductions in markers of depression, anxiety, sleep, quality of life, and cognition.
The investigators hypothesize a greater reduction in depressive symptoms, anxiety symptoms compared to that seen in the control group. The investigators also hypothesize improvements in sleep, quality of life and cognition compared to the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18-55 years old
- •Have a diagnosis of bipolar I or bipolar II disorder, confirmed by the Quick Structured Clinical Interview for DSM-5® Disorders, QuickSCID-
- •Have depression symptoms as indicated by a score of ≥12 on MADRS and ≤12 on YMRS.
- •Females of childbearing potential are willing to follow highly effective methods of contraception (mentioned below) for the duration of study*
- •Participants must be able to speak, read, write and understand English or French.
- •Be willing and able to provide informed consent.
排除标准
- •Have any catatonic symptoms or eating disorder(s) as measured by the Quick Structured Clinical Interview for DSM-5® Disorders, QuickSCID-
- •Have any unstable or inadequately treated neurological and medical conditions.
- •Have had prior bariatric surgery. 4 Be taking hypoglycemia inducing medications.
- •5. Be pregnant or lactating.
- •Currently taking any stimulant medications.
- •Be participating in any other diet or weight management program for the duration of the trial.
- •8. Have any contraindication to fasting as judged by the assessing clinician.
- •Recently (i.e. within the past 8 weeks) began structured psychotherapy (i.e. cognitive-behavioral therapy, interpersonal psychotherapy, family-focused therapy, or interpersonal and social rhythm therapy).
- •10. Have any other medical condition, substance use disorder or suicidal ideation for which physician or investigator team expresses concern about safety or ability to participate in the study.
研究组 & 干预措施
Group 1: Eating ad libitum, nutritional counselling plus treatment as usual
Participants randomized to this group will be offered nutritional counselling from a registered dietician. They will also receive a check-in from the registered dietician at week 4. They will also continue to receive treatment as usual. Treatment as usual includes pharmacological treatment options such as mood stabilizers and/or atypical antipsychotics, and psychological treatments such as psychotherapy. No current treatments will be stopped to participate in the study. We will record changes made to the doses of medications during the trial. No new treatments will be started for the duration of the trial, including pharmacological and psychological treatments
干预措施: Eating ad libitum with nutritional counselling (Behavioral)
Group 2:Time-restricted eating plus treatment as usual
In addition to the nutritional counselling and continuing treatment as usual outlined in Group 1, this group will be provided time restricted eating instruction. The experimental group will be instructed to select a consistent 10-h eating window between 06:00 and 19:00 for all days of the week to consume all food and beverages (except water) for the duration of the 8-week intervention. Adherence to the intervention will be monitored weekly through phone check-ins with the research assistant. At 4-weeks, the study dietician will have a 1-hour check in with participants to review progress and adherence to TRE and to address any difficulties the participants may be facing.
干预措施: Time restricted eating (Behavioral)
结局指标
主要结局
Time to recruit all participants
时间窗: 18 months
The investigators will consider the intervention feasible if 70% of participants complete follow-up.
Rate of participation
时间窗: 18 months
The investigators will consider the intervention acceptable if at least 50% of potential participants approached about the study agree to participate.
Intervention adherence
时间窗: 18 months
The investigators will consider the intervention acceptable if participant adherence to the intervention is at least 70% (i.e. participants adhere to the TRE intervention 40 days out of 56 days); ii) at least 50% of participants approached about the study agree to participate.
Number of participants who complete the study
时间窗: 18 months
The investigators will consider the intervention feasible if 70% of participants complete follow-up.
次要结局
- Biological Rhythms - Biological Rhythm Interview for Assessment in Neuropsychiatry(Baseline (week 1), Week 4, Week 8)
- Depression severity - Montgomery-Åsberg Depression Rating Scale(Screening, Baseline (week 1), Week 4, Week 8)
- Cognitive dysfunction - Cognitive Complaints in Bipolar Disorder Rating Assessment(Baseline (week 1), Week 4, Week 8)
- Quality of Life - Brief Quality of Life in Bipolar Disorder Questionnaire(Baseline (week 1), Week 4, Week 8)
- Cognitive Dysfunction - Screen for Cognitive Impairment in Psychiatry(Baseline (week 1), Week 4, Week 8)
- Symptom Severity and Improvement - Clinical Global Impressions-BP-Severity & Improvement (CGI-BP I&S)(Baseline (week 1), Week 4, Week 8)
- Psychological Dysfunction - Functioning assessment short test (FAST)(Baseline (week 1), Week 4, Week 8)
- Anxiety severity - Hamilton Anxiety Rating Scale(Baseline (week 1), Week 4, Week 8)
- Anxiety severity - Generalized Anxiety Disorder-7(Baseline (week 1), Week 4, Week 8)
- Sleep Quality - Reduced Pittsburgh Sleep Quality Index(Baseline (week 1), Week 4, Week 8)
- 19-Item Self-Assessment Questionnaire for Sleep Rhythms, Habits and Fatigue (MEQ)(Baseline (week 1), Week 4, Week 8)
- Function - Global Assessment of Functioning(Baseline (week 1), Week 4, Week 8)
- Mania severity - Young Mania Rating Scale(Screening, Baseline (week 1), Week 4, Week 8)
研究者
Gayatri Saraf
Psychiatrist and Associate Professor
University of Ottawa