Healthy Lifestyles for Bipolar Disorder

Launched by UNIVERSITY OF CALIFORNIA, BERKELEY · Dec 18, 2023

Keywords

ClinConnect Summary

The "Healthy Lifestyles for Bipolar Disorder" clinical trial is exploring how two different healthy eating habits—time-restricted eating and the Mediterranean diet—can affect people with bipolar disorder who are already taking medication. The researchers want to find out how well these eating plans are accepted and how they might help improve mood, reduce symptoms of mania and depression, and enhance overall quality of life. Participants will keep track of their eating, sleep, and mood for two weeks before following one of the two diets for eight weeks. Throughout the study, their symptoms and quality of life will be measured at various points.

To be eligible for this trial, participants must be diagnosed with bipolar I or II disorder, have sleep-related concerns, and be stable on their mood-stabilizing medications for at least a month. They should also be comfortable using technology like a smartphone to complete surveys. Participants will need to keep a dietary log during the study and will be asked to follow specific eating patterns. This study is currently recruiting individuals aged 18 to 65, and those interested in participating should understand that it aims to provide insights into how lifestyle changes can support their mental health alongside traditional medication.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • meets diagnostic criteria for bipolar I disorder or bipolar II disorder (but not cyclothymia, BD Not otherwise specified or BD due to another medical condition)
• • 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 we 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 BD (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, we will manually review for possible invalidity.
• Exclusion criteria include the following:
• • Current episode of depression, hypomania or mania, or psychosis (assessed by the aDiagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and Related Neuropsychiatric Disorders; 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,
• • Medical conditions such as HIV, AIDS, lupus, or multiple sclerosis that could confound the assessment of mania or other measures
• • Medications contraindicated for fasting: clozapine, glucose-lowering medications, diabetes-related injections, medications requiring food early morning or late evening, corticosteroids; medications such as semaglutide will not be an exclusion criteria
• • Cognitive deficits as noted during the initial interview or as indicated by low performance on the Short Orientation Memory Concentration Test (\< 20 on the weighted score).