MedPath

Healthy Lifestyles in Bipolar Disorder: Bay Area Study

Not Applicable
Recruiting
Conditions
Time Restricted Eating
Bipolar Disorder
Interventions
Behavioral: Time-restricted eating for 8 weeks
Registration Number
NCT06555406
Lead Sponsor
University of California, Berkeley
Brief 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.

Detailed Description

This is a single-arm trial to examine the effects of time-restricted eating on change in diurnal rhythms, manic and depressive symptoms, and quality of life. In time-restricted eating (TRE), participants will be asked to limit their food intake to a period of 10 hours per day. TRE will be an addition to standard medication approaches in bipolar disorder. Participants who are receiving medical treatment for bipolar disorder and who report at least some sleep or circadian problems will complete baseline measures and then will be asked to follow TRE for 8 weeks, and then will complete measures of symptoms, Quality of Life, and possible treatment mechanisms at the mid-point of treatment, the end of treatment, and at 3 months after the intervention. If successful, this work will help understand key mechanisms through which TRE provides benefits for those with BD.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
150
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)
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Time Restricted Eating (TRE) for 8 weeksTime-restricted eating for 8 weeksParticipants 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.
Primary Outcome Measures
NameTimeMethod
ManiaLower YMRS at the end of intervention (10 weeks) as compared to baseline

Young Mania Rating Scale (YMRS) total scores (minimum: 0, maximum: 60, high scores reflect higher manic symptom severity)

DepressionLower MADRS at the end of intervention (10 weeks) as compared to baseline

Montgomery Asberg Depression Scale (MADRS) total scores (minimum: 0, maximum: 60, higher scores reflect higher depressive symptom severity)

Self-rated Quality of Life (QOL)Scores at 1.5-months post-intervention (16 weeks) as compared to baseline

self-rated Brief Quality of Life in Bipolar Disorder (QoL.BD) (minimum: 12, maximum: 60, higher scores reflect better QOL)

Secondary Outcome Measures
NameTimeMethod
Acceptabilityimmediately post-treatment (10 weeks after enrollment)

Participant self-ratings of the acceptability of the intervention: The primary index of acceptability will be the percentage of individuals who endorse that they agree or strongly agree that they would recommend the food plan to a friend. This single item has been used in previous trials of bipolar disorder. Higher agreement will be considered a positive outcome.

Daily emotional lability as assessed using ecological momentary assessment7 weeks post-study entry as compared to baseline

Mean square of successive difference of negative affect scores within derived from the ecological momentary assessments at 7 weeks post-baseline as compared to baseline. Participants will be asked to complete negative affect ratings 5 times per day for 7 days, at the baseline and mid-point of treatment. The investigators will calculate scores to examine the degree of negative affect variability for each day, and then take the average across 7 days at baseline and at treatment mid-point. Better outcomes would be indicated by lower scores.

Mania at follow-upYMRS and LIFE scores will be lower at 3 months post-intervention as compared to baseline

YMRS (described above) and Longitudinal Interval Follow-up Evaluation (LIFE; minimum 0, maximum 6) scores across follow-up (higher scores reflect more severe symptoms)

Self-rated maniaLower PMQ scores at post-intervention (10 weeks) and at 1.5 and 3 months follow-ups post-intervention, as compared to baseline

Patient Health Questionnaire (PMQ) Mania scores (minimum: 0, maximum: 27, higher scores reflect more severe mania)

Self-rated depressionpost-intervention (10 weeks) and at 1.5 and 3 months follow-ups post-intervention, as compared to baseline

Patient Health Questionnaire (PHQ) Depression scores (minimum: 0, maximum: 27, higher scores reflect more severe depression)

Weekly change in mania severityWeekly scores from the end of the intervention through 3 months post-intervention

Longitudinal Interval Follow-up Evaluation (LIFE) weekly mania scores post-treatment as compared to those at baseline. The investigators will administer the LIFE interview at 6 months after study entry, and interviewers will record a mania severity rating for each week, to cover the time from the end of intervention until 6-month follow-up. Better outcomes would be reflected in lower LIFE scores post-treatment.

Depression at follow-upMADRS scores will be lower at 3 months post-intervention as compared to baseline

MADRS scores (described above) across follow-up

Trial Locations

Locations (1)

University of California Berkeley

🇺🇸

Berkeley, California, United States

© Copyright 2025. All Rights Reserved by MedPath