Not provided
Not provided
Not provided
Not provided
Not provided
decided to shift to a new design and measures
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a pilot trial to examine the acceptability and feasibility of time-restricted eating as an adjunct to medication treatment for bipolar disorder.
Time-restricted eating (TRE) is a way of scheduling food intake that has been shown to improve circadian rhythms in animals and humans. TRE is based on animal and human science that shows that the timing of eating powerfully influences diurnal rhythms. Animal research has shown that feeding during sleep periods leads to a surge of norepinephrine, cortisol, wakefulness, and activity. Drawing on this, over a decade of studies have examined the impact of experimentally randomizing mice to time-restricted feeding during wake hours (vs. 24-hour ad libitum feeding). Importantly, caloric intake and other facets of diet were yoked for strict control. A consistent finding is that TRE had powerful benefits for circadian and metabolic indicators across studies,and more recent data also shows benefit for animal longevity.
Here, the investigators' goal is to extend this work to bipolar disorder (BD). More specifically, the investigators will gather data to examine the acceptability and feasibility of TRE among those who self-identify with bipolar disorder and who experience some problems with sleep, circadian rhythms, or schedules. The investigators will gather measures of mania, depression, sleep, and QOL, to provide preliminary evidence of change on these dimensions.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| time-restricted eating | Experimental | Post-baseline, participants will be asked to restrict their eating to a 10-hour window. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| time-restricted eating | Behavioral | Restrict eating to a 10-hour window. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability as assessed using self-ratings on items designed for this study | self-ratings of the acceptability of the intervention | Immediately post-treatment (10 weeks) |
| Feasibility as assessed by percent of clients who complete the assessments and intervention | Percentage of clients who do not drop out of the trial. Drop out would be defined as not completing the TRE intervention, or failing to complete the end-of-treatment intervention. | Immediately post-treatment (10 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Lower Mania symptoms as assessed with the Patient Mania Questionnaire-9 | Self-Rated Patient Mania Questionnaire-9 | Change from baseline to immediately post-treatment (10 weeks) |
| Lower Depression symptoms as assessed with the Patient Health Questionnaire-9 |
| Measure | Description | Time Frame |
|---|---|---|
| Higher Functional impairment on the World Health Organization Disability Assessment Schedule (WHO-DAS2.0) | WHO-DAS2.0 nonphysical health-related scales | Change from baseline to immediatly post-treatment (10 weeks) |
Inclusion Criteria:
Exclusion Criteria:
Cognitive deficits (Screening OMC Test)
Current: psychosis, (hypo)mania, major depressive episode, substance/alcohol use disorders, eating disorder diagnoses or acute suicidal risk (MINI interview; see DSM5 TRE screening)
High scores (> 5) on the Screening Eating Disorder Examination Questionnaire
Current shift work
>5 kg weight change within 3 months
Pregnancy
Breastfeeding
Uncorrected hypo or hyperthyroidism
* diabetes type 1
Gastrointestinal conditions impairing nutrient absorption
Medications contraindicated for fasting, including clozapine, glucose-lowering medications, diabetes-related injections, requiring food early morning or late evening, corticosteroids.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Berkeley | California | 94720 | United States |
Not provided
| Label | URL |
|---|---|
| link to study team website | View source |
Not provided
De-identified data will be available at OSF post-study.
Within one year of study completion, if ethics board approves.
Available through OSF.
Not provided
Not provided
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Participants will take part in a baseline assessment, then all will be assigned to time-restricted eating.
Not provided
Not provided
Not provided
Not provided
PHQ-9 |
| Change from baseline to immediately post-treatment (10 weeks) |
| Lower scores on two Patient Reported Outcome Measurement Information System (PROMIS) sleep scales | PROMIS self-report of sleep disturbance and sleep-related impairment (summed together) | Change from baseline to immediately post-treatment (10 weeks) |
| higher scores on Self-rated Quality of Life | Brief Quality of Life in Bipolar Disorder scale | Change from baseline to immediatly post-treatment (10 weeks) |