RecruitingNot Applicable

Healthy Lifestyles for Bipolar Disorder

United States300 participantsStarted 2024-06-05

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 le…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acceptability

Timeframe: immediately post-treatment (10 weeks after enrollment)

Adherence to time-restricted eating

Timeframe: Average number of daily food logs showing adherence across the 8-week intervention

Adherence to Mediterranean Diet

Timeframe: 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

Timeframe: Lower YMRS at the end of intervention (10 weeks) as compared to baseline

Depression

Timeframe: Lower MADRS at the end of intervention (10 weeks) as compared to baseline

Self-rated Quality of Life (QOL)

Timeframe: Scores at 1.5-months post-intervention (16 weeks after study entry) as compared to baseline

Mania at follow-up

Timeframe: YMRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline

Trial details

NCT IDNCT06188754

SponsorUniversity of California, Berkeley

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-28

Contact for this trial

Sheri L Johnson, PhD

(510) 519-4305 calmprogram@berkeley.edu

View on ClinicalTrials.gov More Time Restricted Eating trials