Healthy Lifestyles for Bipolar Disorder

Официальное название

Time-restricted Eating vs. Mediterranean Diet as Adjunctive Interventions for Bipolar Disorder

Обзор

The goal of this clinical trial is to compare the effects of two different healthy lifestyles on outcomes for those with bipolar disorder. The goals are to understand the acceptability of time-restricted eating and the mediterranean diet for those who are already receiving medication treatment for bipolar disorder, and to consider how these two food plans predict changes in manic symptoms, depressive symptoms, and Quality of Life. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow one of the two food plans for eight weeks. The investigators will measure symptoms and Quality of Life at baseline and during and after the food plan.

Подробное описание

The investigators will conduct a randomized controlled trial (RCT) to examine the effects of time-restricted eating as compared to the mediterranean diet. In time-restricted eating (TRE), participants will be asked to limit their food intake to a period of 10 hours per day. In the mediterranean diet, participants will be asked to follow a food plan that emphasizes vegetables, fruit, whole grains, and olive oil as central dietary components. The investigators aim to test both food plans as additions to standard medication approaches in bipolar disorder. Participants who are receiving medical treatment for bipolar disorder and who report at least some sleep or circadian problems will complete baseline measures and then will be randomly assigned to TRE or the mediterranean diet for 8 weeks, and then will complete measures of symptoms, Quality of Life, and possible treatment mechanisms at the end of treatment and at 3, 6 and 12 months after the intervention. If successful, this work will provide a novel, easily implemented and highly acceptable intervention for BD.

Вмешательства

• Поведенческое Time restricted eating
  Limiting food intake to 10 hours per day
• Поведенческое Mediterranean diet
  Dietary advice designed to improve consumption of vegetables, fruits, whole grains, and the use of olive oil.

Первичные конечные точки

• Acceptability [Срок оценки: immediately post-treatment (10 weeks after enrollment)]
• Adherence to time-restricted eating [Срок оценки: Average number of daily food logs showing adherence across the 8-week intervention]
• Adherence to Mediterranean Diet [Срок оценки: Average number of food logs showing adherence at or above the median for 2 days at the mid-point of treatment (week 6) and at the end of treatment (week 10)]
• Mania [Срок оценки: Lower YMRS at the end of intervention (10 weeks) as compared to baseline]
• Depression [Срок оценки: Lower MADRS at the end of intervention (10 weeks) as compared to baseline]
• Self-rated Quality of Life (QOL) [Срок оценки: Scores at 1.5-months post-intervention (16 weeks after study entry) as compared to baseline]
• Mania at follow-up [Срок оценки: YMRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline]
• Depression at follow-up [Срок оценки: MADRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline]
• QOL at follow-up [Срок оценки: Brief QOL.BD scores will be higher at 6- and 12-month post-intervention follow-ups as compared to baseline]

Вторичные конечные точки (8)

• Self-rated mania [Срок оценки: at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention, as compared to baseline]
• Self-rated depression [Срок оценки: at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention, as compared to baseline]
• Sleep hygiene behaviors [Срок оценки: post-intervention (10 weeks) as compared to baseline]
• Weekly change in mania severity [Срок оценки: Weekly scores from the end of the intervention through one-year post-intervention follow-up]
• Sleep disturbance and sleep impairment [Срок оценки: post-treatment (10 weeks) as compared to baseline]
• Sleep mid-point variability (Munich Chronotype Questionnaire; MCTQ) [Срок оценки: post-treatment (10 weeks) as compared to baseline]
• Regularity of daily routines (Brief Social Rhythm Questionnaire) [Срок оценки: post-treatment (10 weeks) as compared to baseline]
• Daily emotional lability as assessed using ecological momentary assessment [Срок оценки: mid-point of treatment (6 weeks post study entry) as compared to baseline]

Критерии участия

Критерии включения

• meets diagnostic criteria for bipolar I disorder or bipolar II disorder (but not cyclothymia, BD Not otherwise specified or BD due to another medical condition)
• current sleep (insomnia, hypersomnolence) or circadian sleep-wake (delayed phase, advanced phase, irregular sleep-wake, non-24-hour sleep-wake-type) concerns indicated by endorsement of at least some sleep or circadian-related impairment across the screening self-reports or interview

• Living in an English-speaking country (and one that we have expertise in research procedures and diet)
• Has been speaking English for at least 10 years, speaks English in the home, or certifies that they are able to understand English well for the study and demonstrates this during the screening interview.
• Receiving medical care for BD (referrals will be provided for those who would like to begin care)
• Mood-stabilizing medication regimens stable for at least one month
• < 5 kg weight change in the past 3 months
• Currently eating ≥ 12 hours per day at least twice per week
• Able to operate the camera function and respond to web-based surveys by phone (loaner phones will be provided as needed)
• Not engaged in current shift work or have other responsibilities such as providing care that would chronically disrupt their sleep (i.e., > 3 h between 22:00 and 05:00 h for at least 1 day/week)
• Able to complete 7 days of dietary logs adequately (e.g., at least 2 entries per day, covering at least a 5-hour eating window) during the baseline period
• Able to complete screening and baseline questionnaires adequately (e.g., not failing more than 1 attention check item with instructed responding; responding to standard multiple-choice items in a mean of < 2 seconds per item). Where individuals respond to more than 14 items in a row with the same response, we will manually review for possible invalidity.

Exclusion criteria include the following:

• Current episode of depression, hypomania or mania, or psychosis (assessed by the aDiagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and Related Neuropsychiatric Disorders; DIAMOND), Participants with acute mood disorder episodes will be encouraged to seek treatment and to consider the study when symptoms have remitted.
• Eating disorder diagnosis (by self-report of treatment or diagnosis at any point during their life, Short Eating Disorder Examination Questionnaire (EDE-QS) scores above clinical concern thresholds for eating disorders, or DIAMOND interview of symptoms during adulthood)
• Past 3-month alcohol use disorder or substance use disorder (assessed by DIAMOND)
• Active suicidal ideation coupled with plan, intent or attempt history as assessed by Columbia Suicide Severity Rating Scale
• Conditions that would interfere with ability to take part in the intervention , including pregnancy, breastfeeding, uncorrected hypo or hyperthyroidism, gastrointestinal conditions impairing nutrient absorption,
• Medical conditions such as HIV, AIDS, lupus, or multiple sclerosis that could confound the assessment of mania or other measures
• Medications contraindicated for fasting: clozapine, glucose-lowering medications, diabetes-related injections, medications requiring food early morning or late evening, corticosteroids; medications such as semaglutide will not be an exclusion criteria
• Cognitive deficits as noted during the initial interview or as indicated by low performance on the Short Orientation Memory Concentration Test (< 20 on the weighted score).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of California — Berkeley

Публикации

• Johnson SL, Murray G, Kriegsfeld LJ, Manoogian ENC, Mason L, Allen JD, Berk M, Panda S, Rajgopal NA, Gibson JC, Joyner KJ, Villanueva R, Michalak EE. A randomized controlled trial to compare the effects of time-restricted eating versus Mediterranean diet on symptoms and quality of life in bipolar disorder. BMC Psychiatry. 2024 May 18;24(1):374. doi: 10.1186/s12888-024-05790-4. PMID 38762486

Идентификаторы

NCT: NCT06188754 · Healthy Lifestyles 01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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