RecruitingNot Applicable

Healthy Lifestyles in Bipolar Disorder: Bay Area Study

United States150 participantsStarted 2024-11-22

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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, bipolar disorder Not otherwise specified or bipolar disorder due to another medical condition) assessed by the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and Related Neuropsychiatric Disorders \[DIAMOND\]) * 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 the researchers 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 bipolar disorder (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 slee…

What they're measuring

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) as compared to baseline

Trial details

NCT IDNCT06555406

SponsorUniversity of California, Berkeley

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-02-01

Contact for this trial

Sheri L Johnson, PhD

(510) 519-4305 calmprogram@berkeley.edu

View on ClinicalTrials.gov More Bipolar Disorder trials