RECRUITING

Healthy Lifestyles in Bipolar Disorder: Bay Area Study

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Conditions

Bipolar DisorderTime Restricted Eatingsleepinsomniacircadian rhythms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Time-restricted Eating as an Adjunctive Intervention for Bipolar Disorder

Quick Facts

Study Start:2024-11-22
Study Completion:2029-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06555406

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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 \[DIAMOND\])
  2. * 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
  3. * Living in an English-speaking country (and one that the researchers have expertise in research procedures and diet)
  4. * 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.
  5. * Receiving medical care for bipolar disorder (referrals will be provided for those who would like to begin care)
  6. * Mood-stabilizing medication regimens stable for at least one month
  7. * \< 5 kg weight change in the past 3 months
  8. * Currently eating ≥ 12 hours per day at least twice per week
  9. * Able to operate the camera function and respond to web-based surveys by phone (loaner phones will be provided as needed)
  10. * 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)
  11. * 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
  12. * 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.
  13. * 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.
  14. * 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)
  15. * Past 3-month alcohol use disorder or substance use disorder (assessed by DIAMOND)
  16. * Active suicidal ideation coupled with plan, intent or attempt history as assessed by Columbia Suicide Severity Rating Scale
  17. * Conditions that would interfere with ability to take part in the intervention, including pregnancy, breastfeeding, uncorrected hypo or hyperthyroidism, gastrointestinal conditions impairing nutrient absorption
  18. * Conditions that would confound immune or other study measures, such as HIV, AIDS, lupus, or multiple sclerosis
  19. * 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
  20. * 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)
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Sheri L Johnson, PhD
CONTACT
(510) 519-4305
calmprogram@berkeley.edu
Nandini A Rajgopal, BS
CONTACT
(510) 519-4305
calmprogram@berkeley.edu

Principal Investigator

Sheri L Johnson, PhD
PRINCIPAL_INVESTIGATOR
University of California, Berkeley

Study Locations (Sites)

University of California Berkeley
Berkeley, California, 94720-2010
United States

Collaborators and Investigators

Sponsor: University of California, Berkeley

  • Sheri L Johnson, PhD, PRINCIPAL_INVESTIGATOR, University of California, Berkeley

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-22
Study Completion Date2029-02-01

Study Record Updates

Study Start Date2024-11-22
Study Completion Date2029-02-01

Terms related to this study

Keywords Provided by Researchers

  • sleep
  • insomnia
  • circadian rhythms

Additional Relevant MeSH Terms

  • Bipolar Disorder
  • Time Restricted Eating