Healthy Lifestyles in Bipolar Disorder: Bay Area Study
NCT Number: NCT06555406
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bipolar Disorder|Time Restricted Eating
Interventions: BEHAVIORAL: Time-restricted eating for 8 weeks
Sponsor: University of California, Berkeley
Collaborators: Salk Institute for Biological Studies|University College, London|Swinburne University of Technology|Deakin University|University of British Columbia|Wellcome Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2029-02-01

Summary:
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.

Primary Outcome Measures: Mania, Young Mania Rating Scale (YMRS) total scores (minimum: 0, maximum: 60, high scores reflect higher manic symptom severity), 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), 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), Scores at 1.5-months post-intervention (16 weeks) as compared to baseline
Secondary Outcome Measures: 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), 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, 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), 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), 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., 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., 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., 7 weeks post-study entry as compared to baseline