The goal of this clinical trial is to understand how level of adherence with time-restricted eating (TRE) predicts change in diurnal rhythms (as measured using the amplitude of diurnal peripheral clock gene expression), and how those changes predict lower mania and depressive symptoms, and downstream improvements in quality of life. The effects of diurnal amplitude of clock gene expression is expected to remain significant when controlling for change in glucose tolerance and inflammation. Participants will be enrolled who are already receiving medication treatment for bipolar disorder. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow TRE for eight weeks. Symptoms and Quality of Life will be measured at baseline and during and after the food plan.
This is a single-arm trial to examine the effects of time-restricted eating on change in diurnal rhythms, manic and depressive symptoms, and quality of life. In time-restricted eating (TRE), participants will be asked to limit their food intake to a period of 10 hours per day. TRE will be an addition 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 asked to follow TRE for 8 weeks, and then will complete measures of symptoms, Quality of Life, and possible treatment mechanisms at the mid-point of treatment, the end of treatment, and at 3 months after the intervention. If successful, this work will help understand key mechanisms through which TRE provides benefits for those with BD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
limiting food intake to 10 hours per day
University of California Berkeley
Berkeley, California, United States
RECRUITINGMania
Young Mania Rating Scale (YMRS) total scores (minimum: 0, maximum: 60, high scores reflect higher manic symptom severity)
Time frame: Lower YMRS at the end of intervention (10 weeks) as compared to baseline
Depression
Montgomery Asberg Depression Scale (MADRS) total scores (minimum: 0, maximum: 60, higher scores reflect higher depressive symptom severity)
Time frame: Lower MADRS at the end of intervention (10 weeks) as compared to baseline
Self-rated Quality of Life (QOL)
self-rated Brief Quality of Life in Bipolar Disorder (QoL.BD) (minimum: 12, maximum: 60, higher scores reflect better QOL)
Time frame: Scores at 1.5-months post-intervention (16 weeks) as compared to baseline
Mania at follow-up
YMRS (described above) and Longitudinal Interval Follow-up Evaluation (LIFE; minimum 0, maximum 6) scores across follow-up (higher scores reflect more severe symptoms)
Time frame: YMRS and LIFE scores will be lower at 3 months post-intervention as compared to baseline
Depression at follow-up
MADRS scores (described above) across follow-up
Time frame: MADRS scores will be lower at 3 months post-intervention as compared to baseline
Self-rated mania
Patient Health Questionnaire (PMQ) Mania scores (minimum: 0, maximum: 27, higher scores reflect more severe mania)
Time frame: Lower PMQ scores at post-intervention (10 weeks) and at 1.5 and 3 months follow-ups post-intervention, as compared to baseline
Self-rated depression
Patient Health Questionnaire (PHQ) Depression scores (minimum: 0, maximum: 27, higher scores reflect more severe depression)
Time frame: post-intervention (10 weeks) and at 1.5 and 3 months follow-ups post-intervention, as compared to baseline
Acceptability
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)
Weekly change in mania severity
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 6 months after study entry, and interviewers will record a mania severity rating for each week, to cover the time from the end of intervention until 6-month follow-up. Better outcomes would be reflected in lower LIFE scores post-treatment.
Time frame: Weekly scores from the end of the intervention through 3 months post-intervention
Daily emotional lability as assessed using ecological momentary assessment
Mean square of successive difference of negative affect scores within derived from the ecological momentary assessments at 7 weeks post-baseline as compared to baseline. Participants will be asked to complete negative affect ratings 5 times per day for 7 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 7 days at baseline and at treatment mid-point. Better outcomes would be indicated by lower scores.
Time frame: 7 weeks post-study entry as compared to baseline
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