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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
Limiting food intake to 10 hours per day
Dietary advice designed to improve consumption of vegetables, fruits, whole grains, and the use of olive oil.
University of California
Berkeley, California, United States
RECRUITINGAcceptability
Participant self-ratings of the acceptability of the intervention: The primary index of acceptability will be the percentage of individuals who endorse that they agree or strongly agree that they would recommend the food plan to a friend. This single item has been used in previous trials of bipolar disorder. Higher agreement will be considered a positive outcome.
Time frame: immediately post-treatment (10 weeks after enrollment)
Adherence to time-restricted eating
Adherence will be scored based on the time of their first and final calorie consumption each day during the 8 week intervention. The investigators will select entries from the time interval that contains 95% of intake events. Following standards in other US and European studies of TRE, the investigators will focus on days in which participants adequately logged (e.g., entered at least two intake events, covering at least a 5 hour window), and will calculate the percentage of days in which individuals met the eating window goal. High adherence will be defined as meeting this standard on at least 78% of days logged. As supplemental data, the investigators will report the percentage of days logged, and the percentage of days in which individuals logged adequately and followed the planned window.
Time frame: Average number of daily food logs showing adherence across the 8-week intervention
Adherence to Mediterranean Diet
Adherence will be scored based on a Food Frequency Questionnaire that we developed for this study. We will score this using the Adherence to the Mediterranean Diet scoring system (AMed), which provides up to 9 points based on above-median consumption of beneficial foods (e.g., fruits and vegetables) and below median consumption of "extras" such as alcohol. Higher scores reflect better adherence to the mediterranean diet.
Time frame: 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
Decline in Young Mania Rating Scale (YMRS) total scores, completed by a blind rater
Time frame: Lower YMRS at the end of intervention (10 weeks) as compared to baseline
Depression
Decline in Montgomery Asberg Depression Scale (MADRS) total scores, completed by a blind rater
Time frame: Lower MADRS at the end of intervention (10 weeks) as compared to baseline
Self-rated Quality of Life (QOL)
Higher scores on the self-rated Brief Quality of Life in Bipolar Disorder (QoL.BD) at 1.5-months post intervention as compared to baseline
Time frame: Scores at 1.5-months post-intervention (16 weeks after study entry) as compared to baseline
Mania at follow-up
Sustained lower YMRS scores across follow-up
Time frame: YMRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline
Depression at follow-up
Sustained lower MADRS scores across follow-up
Time frame: MADRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline
QOL at follow-up
Sustained higher Brief QOL.BD scores
Time frame: Brief QOL.BD scores will be higher at 6- and 12-month post-intervention follow-ups as compared to baseline
Self-rated mania
Lower Patient Health Questionnaire (PHQ) Mania scores at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention
Time frame: 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
Lower Patient Health Questionnaire (PHQ) Depression scores at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention
Time frame: 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
Lower scores on the Sleep Household Environment and In-Bed Behaviors at end-of-treatment (10 weeks) as compared to baseline
Time frame: post-intervention (10 weeks) as compared to baseline
Weekly change in mania severity
Lower Longitudinal Interval Follow-up Evaluation (LIFE) weekly Mania scores post-treatment as compared to those at baseline. The investigators will administer the LIFE interview at 3, 6, and 12-months after the intervention, and interviewers will record a mania severity rating for each week, to cover the time from the end of intervention until one year after the intervention ends.
Time frame: Weekly scores from the end of the intervention through one-year post-intervention follow-up
Sleep disturbance and sleep impairment
Lower scores on the Patient Outcomes Reporting Information System (PROMIS) sleep disturbance and sleep impairment scores at post-treatment (10 weeks) as compared to baseline
Time frame: post-treatment (10 weeks) as compared to baseline
Sleep mid-point variability (Munich Chronotype Questionnaire; MCTQ)
MCTQ scores will show a smaller proportion of individuals with either early or delayed chronotype (as reflected in standard scoring for the MCTQ) at post-treatment as compared to baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: post-treatment (10 weeks) as compared to baseline
Regularity of daily routines (Brief Social Rhythm Questionnaire)
Lower Brief Social Rhythm Questionnaire scores (less irregularity) at post-treatment as compared to baseline
Time frame: post-treatment (10 weeks) as compared to baseline
Daily emotional lability as assessed using ecological momentary assessment
Lower mean square of successive difference of negative affect scores within derived from the ecological momentary assessments at the mid-point of treatment (6 weeks) as compared to baseline. Participants will be asked to complete negative affect ratings several times per day for 8 days, at the baseline and mid-point of treatment. The investigators will calculate scores to examine the degree of negative affect variability for each day, and then take the average across 8 days at baseline and at treatment mid-point.
Time frame: mid-point of treatment (6 weeks post study entry) as compared to baseline