Exploring Healthy Lifestyles for Bipolar Disorder in the Bay Area

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates how adherence to time-restricted eating (TRE) affects diurnal rhythms and symptoms of bipolar disorder. Participants, who are already receiving medication for bipolar disorder and experiencing sleep or circadian issues, will follow a TRE regimen for eight weeks while completing daily measures of eating, sleep, and mood. The study aims to assess changes in manic and depressive symptoms, as well as improvements in quality of life, through the evaluation of clock gene expression and other health markers. Data will be collected at baseline, during, and after the intervention to understand the potential benefits of TRE in managing bipolar disorder.

Why it matters

Who can join: the full rules

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 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 least a 5-hour eating window) during the baseline period
* Able to complete screening and baseline questionnaires adequately (e.g., not failing more than 1 attention check item with instructed responding; responding to standard multiple-choice items in a mean of \< 2 seconds per item). Where individuals respond to more than 14 items in a row with the same response, their answers will be manually reviewed for possible invalidity.

Exclusion criteria include the following:

* Current episode of depression, hypomania or mania, or psychosis (assessed by the DIAMOND), Participants with acute mood disorder episodes will be encouraged to seek treatment and to consider the study when symptoms have remitted.
* Eating disorder diagnosis (by self-report of treatment or diagnosis at any point during their life, Short Eating Disorder Examination Questionnaire (EDE-QS) scores above clinical concern thresholds for eating disorders, or DIAMOND interview of symptoms during adulthood)
* Past 3-month alcohol use disorder or substance use disorder (assessed by DIAMOND)
* Active suicidal ideation coupled with plan, intent or attempt history as assessed by Columbia Suicide Severity Rating Scale
* Conditions that would interfere with ability to take part in the intervention, including pregnancy, breastfeeding, uncorrected hypo or hyperthyroidism, gastrointestinal conditions impairing nutrient absorption
* Conditions that would confound immune or other study measures, such as HIV, AIDS, lupus, or multiple sclerosis
* Medications contraindicated for fasting: clozapine, glucose-lowering medications, diabetes-related injections, medications requiring food early morning or late evening, corticosteroids; Glucagon-like peptide-1 (GLP-1) agonists will not be an exclusion criteria if weight stabilized
* Cognitive deficits as noted during the initial interview or as indicated by low performance on the Orientation Memory Concentration Test- Short Version (weighted score \< 20)

Where it's running

• University of California Berkeley
  Berkeley, California, United States Recruiting

Study contacts

• Principal investigator: Sheri L Johnson, PhD — University of California, Berkeley
• Study coordinator: Sheri L Johnson, PhD
• Email: calmprogram@berkeley.edu
• Phone: (510) 519-4305

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effects of comorbidity on people with severe mental illness

  This study tests how having both alcohol/substance use and a severe mental illness affects hospitalizations, medications, and social participation among adults followed at a mental health center.

  Recruiting Abant Izzet Baysal University · Bolu, Bolu · NCT07692984

• Venous Tourniquet with Low-Dose Sugammadex vs Arterial Tourniquet for Seizure Monitoring During ECT

  40 patients undergoing ECT will have a venous tourniquet on one arm and an arterial tourniquet on the other to see which method better reveals motor seizures.

  Recruiting Medipol University · Istanbul · NCT07534475

• 7T MRI and visual perception markers for severe mood and psychotic disorders

  This project tests whether 7‑tesla MRI scans combined with visual perception tests can identify brain markers linked to diagnosis and treatment outcomes in adults with major depressive disorder, bipolar disorder, or schizophrenia.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07479758

• Emotional Eating, Sleep Quality, Mental State, and Metabolic Syndrome in Psychiatric Patients

  This study tests how mood, sleep, and emotional eating relate to metabolic syndrome in people with schizophrenia or bipolar disorder.

  Recruiting Abant Izzet Baysal University · Bolu, Bolu · NCT07411222

• Early Time-Restricted Eating in Adults With Mild Asthma and Those Without Asthma

  Researchers will see if eating all meals within a set early window affects health and quality of life in adults with mild asthma compared with adults without asthma.

  Recruiting De Montfort University · Leicester, England · NCT07345572

• À deux, c'est mieux — group program to improve romantic relationships for young adults with severe mental illness

  This program will try a 12-week, small-group course to help single adults with severe mental illness build skills for dating, communication, and closer social relationships.

  Recruiting at 2 sites Centre hospitalier de Ville-Evrard, France · Épinay-sur-Seine, Île-de-France Region and 1 other locations · NCT07316803

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.