Time-Restricted Eating and Bipolar Disorder

NCT06105294 | Terminated

• 1 other identifier: 2022-10-15725
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot trial to examine the acceptability and feasibility of time-restricted eating as an adjunct to medication treatment for bipolar disorder.

Conditions

Bipolar Disorder

Keywords

eating; circadian

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (4)

• Lower Mania symptoms as assessed with the Patient Mania Questionnaire-9

  Change from baseline to immediately post-treatment (10 weeks)

• Lower Depression symptoms as assessed with the Patient Health Questionnaire-9

  Change from baseline to immediately post-treatment (10 weeks)

• Lower scores on two Patient Reported Outcome Measurement Information System (PROMIS) sleep scales

  Change from baseline to immediately post-treatment (10 weeks)

• higher scores on Self-rated Quality of Life

  Change from baseline to immediatly post-treatment (10 weeks)

Other Outcomes (1)

• Higher Functional impairment on the World Health Organization Disability Assessment Schedule (WHO-DAS2.0)

  Change from baseline to immediatly post-treatment (10 weeks)

Study Arms (1)

time-restricted eating

EXPERIMENTAL

Post-baseline, participants will be asked to restrict their eating to a 10-hour window.

Behavioral: time-restricted eating

Interventions

time-restricted eating BEHAVIORAL

Restrict eating to a 10-hour window.

time-restricted eating

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults diagnosed with bipolar disorder and currently receiving medical care for their bipolar disorder.
• Experiencing schedule/sleep or circadian problem in the past 3 months
• Medication regimens stable for past month
• Adequate English language skills for taking part in the program.
• Living in California.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Berkeley: lead

Study Sites (1)

University of California

Berkeley, California, 94720, United States

Location

Related Links

• link to study team website

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will take part in a baseline assessment, then all will be assigned to time-restricted eating.

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: October 27, 2023
• Study Start: June 1, 2023
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within one year of study completion, if ethics board approves.
• Access Criteria: Available through OSF.

Locations

US (1)