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Behavioral Intervention

(Bay Area Study) Intermittent Fasting for Bipolar Disorder

Berkeley, CA

N/A

Recruiting

Led By Sheri L Johnson, PhD

Research Sponsored by University of California, Berkeley

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Receiving medical care for bipolar disorder (referrals will be provided for those who would like to begin care)

* 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

Timeline

Screening 2 weeks

Treatment 8 weeks

Follow Up 6 days

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study how following a time-restricted eating plan affects daily rhythms in the body's clock genes, and how this may impact symptoms of mania and depression in individuals with bipolar disorder.

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Who is the study for?

This trial is for individuals with bipolar I or II disorder, who speak English and have been on a stable mood-stabilizing medication regimen for at least one month. They should not have had significant weight changes recently, eat over a 12-hour period regularly, and can use a phone camera and web surveys. People with sleep disorders or those doing shift work that disrupts sleep are excluded.Check my eligibility

What is being tested?

The study tests if following an 8-week time-restricted eating plan affects the body's natural rhythms and if these changes can improve mania and depression symptoms in people with bipolar disorder. Participants will also track their eating, sleep, mood daily before starting TRE.See study design

What are the potential side effects?

While specific side effects are not detailed here, time-restricted eating may lead to hunger outside of eating windows, potential changes in energy levels during fasting periods, possible headaches or irritability due to adjustments in meal timing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently receiving treatment for bipolar disorder.

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I have sleep problems or my sleep schedule is irregular.

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I have been speaking English for 10+ years or can understand it well for this study.

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My mood-stabilizing medication has been the same for at least a month.

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My sleep is not regularly disrupted by work or caregiving duties.

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I eat for 12 or more hours a day at least twice a week.

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Timeline

Screening ~ 2 weeks0 visits

Treatment ~ 8 weeks2 visits

Follow Up ~ 6 days0 visits

Screening ~ 2 weeks

Treatment ~ 8 weeks

Follow Up ~6 days

This trial's timeline: 2 weeks for screening, 8 weeks for treatment, and 6 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Depression

Mania

Self-rated Quality of Life (QOL)

Secondary study objectives

Acceptability

Daily emotional lability as assessed using ecological momentary assessment

Depression at follow-up

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Time Restricted Eating (TRE) for 8 weeksExperimental Treatment1 Intervention

Participants will receive an intro to TRE and then throughout 8 weeks they will receive brief online psychoeducation several times per week with optional weekly coaching sessions. TRE involves restricting the window of eating to 10 hours/ day, most typically by avoiding eating in the first 1-2 hours after awakening and in the 2-4 before sleep. Those with an eating window \> 14 hours will be asked to restrict their eating to 12 hours in the first week, then 10 hours in week 2. To select the period, investigators will ask Ss to review baseline logs to consider sleep, eating, family meals and social commitment schedules, and any special energy demands, such as exercise. During the eating window, no restrictions are placed on the type or quantity of food consumed. The investigators will instruct participants to follow their habitual diet within their 10-hour eating window and to aim to consume the same number of calories per day as they did at baseline.

0 / 6Eligibility criteria met