Pilot Trial of Time Restricted Eating to Support an Adaptive Innovative Clinical Trial of Combined Chronotherapies for Mania in Bipolar Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Feasibility of Time-Restricted Eating: 2) Adherence to Protocol
Study Overview
Brief Summary
The sleep-wake cycle is severely disrupted during an episode of mania. Often mania is treated with medications that can come with significant side effects. Years of patient and family engagement with this population have revealed great interest in therapies targeting the sleep-wake cycle. However, there is still a lack of studies to support using these treatments for mania. Patient partners are especially interested in two specific therapies for mania, blue-blocking glasses and time-restricted eating, because of their perceived feasibility and safety. This pilot study will formally investigate the feasibility and effectiveness of these therapies for participants with mania, an understudied population that faces many difficulties even after recovery. The pilot study will collect interviews to identify barriers and ways to better support patients with mania using the therapies. The study will also investigate how well these therapies can treat manic symptoms and restore sleep-wake cycles by tracking symptom rating scales and measuring activity levels. Results from this pilot will be used to direct a larger study that will use a state-of-the art design to test the effectiveness of both therapies alone and in combination.
Detailed Description
This pilot study will assess feasibility and preliminary data for a novel circadian intervention in a clinical population that has been understudied, patients dealing with manic episodes of bipolar disorder, with an equity, diversity, and inclusion plan to ensure broad demographic representation.
The investigators' long-term goal is to conduct an innovative adaptive, 2x2 factorial study of these two interventions to determine the effects of each individual component and potential synergistic interactions. An adaptive design will allow interim analyses for sample size during which futility can also be assessed. This may potentially reduce cost and time of the later full trial, while ensuring that relevant findings are obtained. To inform a later 2x2 factorial study, researchers will need to gather data on the feasibility of time restricted eating in mania and identify any forms of support required to facilitate this chronotherapy. This is a randomized, parallel three group pilot study of blue-blocking glasses, time restricted eating, or blue-blocking glasses plus time-restricted eating in inpatients with mania. This project has three specific aims:
Aim 1: To assess the feasibility of time restricted eating (10:14 of diurnal eating to nocturnal fasting based on patient partners' input) as an adjunctive treatment for mania in an inpatient setting. Feasibility will be assessed through monitoring of adherence and qualitative semi-structured interviews with patient participants when they exit the study and staff near the study end date. The purpose of these interviews is to identify any challenges or barriers in implementing this treatment, alone or in combination with blue blocking glasses, and what supports might be needed. The research team will also assess willingness to participate in the study through assessment of participation rates and reasons for accepting or declining.
Aim 2: The investigators will secondarily compare differences between groups on the Young Mania Rating Scale (YMRS), which will be the primary outcome for the future trial.
Aim 3 (exploratory): To explore changes in measures of circadian rhythms and sleep, including as measured with actigraphy and other non-invasive monitoring measures, with the interventions and in relation to recovery from mania.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
The time-restricted eating intervention will be single-blind, only the investigators/outcomes assessors will be blinded. The tinted glasses intervention will be double-blind.
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Be over age 16
- •Have DSM-5-defined manic symptoms that persist beyond the physiological effects of a substance and a YMRS≥20
- •Be willing to have investigators obtain information from the treatment team and electronic medical record
- •Participants must be able to read and understand English or French.
- •Be willing and able to provide informed consent.
Exclusion Criteria
- •Have a history of eating disorders.
- •Have a diagnosis of moderate to severe traumatic brain injury with residual or long-term effects, parenchymal brain surgery or stroke
- •Have a neurocognitive disorder
- •Take hypoglycemia-inducing medications
- •Be pregnant/lactating women
- •Have a diagnosis of sleep apnea
- •Have any other medical condition for which physician or investigator team expresses concern about safety or ability to participate in the study.
Arms & Interventions
Blue-blocking glasses and time-restricted eating
Participants will be wearing the experimental blue-blocking glasses and follow time-restricted eating from 6pm-8am.
Intervention: Blue-blocking glasses (Device)
Blue-blocking glasses and time-restricted eating
Participants will be wearing the experimental blue-blocking glasses and follow time-restricted eating from 6pm-8am.
Intervention: Time-restricted eating (Behavioral)
Blue-blocking glasses and no time-restricted eating
Participants will only be wearing the experimental blue-blocking glasses from 6pm-8am.
Intervention: Blue-blocking glasses (Device)
Lightly tinted glasses and time-restricted eating
Participants will be wearing the control lightly tinted glasses and follow time-restricted eating from 6pm-8am.
Intervention: Time-restricted eating (Behavioral)
Lightly tinted glasses and time-restricted eating
Participants will be wearing the control lightly tinted glasses and follow time-restricted eating from 6pm-8am.
Intervention: Lightly tinted glasses (Device)
Outcomes
Primary Outcomes
Feasibility of Time-Restricted Eating: 2) Adherence to Protocol
Time Frame: Baseline to Week 2 or until discharge, whichever comes first
Feasibility of time restricted eating for inpatients with mania as assessed by self-reported and observed adherence. At each study visit, the research team will consider the participants' self-report, notes in the medical record, and their own observations to select a rating on a Likert scale indicating how closely the participant has adhered to the schedule of their assigned intervention(s): a) Fully adherent; b) Almost fully adherent; c) Mostly adherent; d) Half adherent; e) Mostly non-adherent; f) Barely adherent; g) Not adherent.
Feasibility of Time-Restricted Eating: 3) Qualitative Interviews
Time Frame: One interview prior to the participant's discharge, at the end of their participation in the study.
Feasibility of time restricted eating for inpatients with mania as assessed by qualitative semi-structured interview. The research team will conduct a semi-structured interview with participants to elicit their perspective on the feasibility of time restricted eating in the context of an inpatient research study.
Feasibility of Time-Restricted Eating: 1) Study Participation
Time Frame: Over the lifetime of the study starting at the first patient approached until recruitment is stopped.
Feasibility of time restricted eating for inpatients with mania as assessed by study participation, defined as the ratio of patients who consent to participate in the study after being approached by the research team. This will be reported as a ratio with the number of participants who consented as the numerator and the total number of patients approached for participation in the study as the denominator.
Secondary Outcomes
- Change in the General Anxiety Disorder Questionnaire- 7-Item Measuring Severity of Anxiety Symptoms (GAD-7)(Baseline to Week 2 or until discharge, whichever comes first)
- Change in The Morning Evening Questionnaire - 19-Item Self-Assessment Questionnaire for Sleep Rhythms, Habits and Fatigue (MEQ)(Baseline; Week 1; Week 2 or until discharge, whichever comes first)
- Change in the Young Mania Rating Scale(Baseline to Week 2 or until discharge, whichever comes first)
- Change in The Pittsburgh Sleep Quality Index - 18-Item Self-Assessment to Evaluate Sleep Quality (PSQI)(Baseline; Week 1; Week 2 or until discharge, whichever comes first)
- Change in Circadian Rhythms: 2) Heart Rate(Two 24-hour periods: one starting at the Baseline visit and the other starting at the Week 1 visit.)
- Change in Circadian Rhythms: 3) Body Temperature(Two 24-hour periods: one starting at the Baseline visit and the other starting at the Week 1 visit.)
- Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score(Baseline to Week 2 or until discharge, whichever comes first)
- Change in Circadian Rhythms: 1) Actigraphy(One week of continuous wearing starting at the Baseline visit.)