Healthy Lifestyles for Bipolar Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of California, Berkeley
About this trial
The goal of this clinical trial is to compare the effects of two different healthy lifestyles on outcomes for those with bipolar disorder. The goals are to understand the acceptability of time-restricted eating and the mediterranean diet for those who are already receiving medication treatment for bipolar disorder, and to consider how these two food plans predict changes in manic symptoms, depressive symptoms, and Quality of Life. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow one of the two food plans for eight weeks. The investigators will measure symptoms and Quality of Life at baseline and during and after the food plan.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Time restricted eating
BehavioralLimiting food intake to 10 hours per day
Mediterranean diet
BehavioralDietary advice designed to improve consumption of vegetables, fruits, whole grains, and the use of olive oil.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Time Restricted Eating (TRE) for 8 weeksExperimental treatment 1 intervention
Group B: Mediterranean diet for 8 weeksActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Acceptability
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.
Time frame
immediately post-treatment (10 weeks after enrollment)2
Adherence to time-restricted eating
Adherence will be scored based on the time of their first and final calorie consumption each day during the 8 week intervention. The investigators will select entries from the time interval that contains 95% of intake events. Following standards in other US and European studies of TRE, the investigators will focus on days in which participants adequately logged (e.g., entered at least two intake events, covering at least a 5 hour window), and will calculate the percentage of days in which individuals met the eating window goal. High adherence will be defined as meeting this standard on at least 78% of days logged. As supplemental data, the investigators will report the percentage of days logged, and the percentage of days in which individuals logged adequately and followed the planned window.
Time frame
Average number of daily food logs showing adherence across the 8-week intervention3
Adherence to Mediterranean Diet
Adherence will be scored based on a Food Frequency Questionnaire that we developed for this study. We will score this using the Adherence to the Mediterranean Diet scoring system (AMed), which provides up to 9 points based on above-median consumption of beneficial foods (e.g., fruits and vegetables) and below median consumption of "extras" such as alcohol. Higher scores reflect better adherence to the mediterranean diet.
Time frame
Average number of food logs showing adherence at or above the median for 2 days at the mid-point of treatment (week 6) and at the end of treatment (week 10)4
Mania
Decline in Young Mania Rating Scale (YMRS) total scores, completed by a blind rater
Time frame
Lower YMRS at the end of intervention (10 weeks) as compared to baselineSecondary outcomes
1
Self-rated mania
Lower Patient Health Questionnaire (PHQ) Mania scores at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention
Time frame
at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention, as compared to baseline2
Self-rated depression
Lower Patient Health Questionnaire (PHQ) Depression scores at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention
Time frame
at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention, as compared to baseline3
Sleep hygiene behaviors
Lower scores on the Sleep Household Environment and In-Bed Behaviors at end-of-treatment (10 weeks) as compared to baseline
Time frame
post-intervention (10 weeks) as compared to baseline4
Weekly change in mania severity
Lower 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 3, 6, and 12-months after the intervention, and interviewers will record a mania severity rating for each week, to cover the time from the end of intervention until one year after the intervention ends.
Time frame
Weekly scores from the end of the intervention through one-year post-intervention follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Berkeley
Lead sponsor
University College, London
Collaborator
Swinburne University of Technology
Collaborator
Deakin University
Collaborator
University of British Columbia
Collaborator
Salk Institute for Biological Studies
Collaborator
Wellcome Trust
Collaborator
Source ClinicalTrials.gov