Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06188754

Healthy Lifestyles for Bipolar Disorder

Led by University of California, Berkeley · Updated on 2025-02-06

300

Participants Needed

1

Research Sites

247 weeks

Total Duration

On this page

Sponsors

U

University of California, Berkeley

Lead Sponsor

U

University College, London

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Healthy Lifestyles for Bipolar Disorder

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet diagnostic criteria for bipolar I or bipolar II disorder
  • Have current sleep or circadian-related problems confirmed by screening
  • Live in an English-speaking country with research expertise
  • Speak English well and have used it for at least 10 years or demonstrate understanding
  • Receiving medical care for bipolar disorder
  • Mood-stabilizing medications stable for at least one month
  • Have had less than 5 kg weight change in past 3 months
  • Currently eat for 12 or more hours per day at least twice per week
  • Able to use a camera and respond to web surveys by phone (loaner phones provided if needed)
  • Not engaged in shift work or caregiving that disrupts sleep regularly
  • Able to complete 7 days of dietary logs with at least 2 entries daily
  • Able to complete screening and baseline questionnaires adequately
Not Eligible

You will not qualify if you...

  • Currently experiencing a depressive, hypomanic, manic, or psychotic episode
  • History or treatment of eating disorders or high scores on eating disorder questionnaires
  • Alcohol or substance use disorder in the past 3 months
  • Active suicidal thoughts with plan, intent, or history of attempt
  • Conditions interfering with participation such as pregnancy, breastfeeding, thyroid disorders, or gastrointestinal issues
  • Medical conditions like HIV, AIDS, lupus, or multiple sclerosis that affect mood assessment
  • Use of medications contraindicated for fasting such as clozapine or glucose-lowering drugs
  • Cognitive deficits indicated by low scores on memory and concentration tests

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of California

Berkeley, California, United States, 94720

Actively Recruiting

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Research Team

S

Sheri L Johnson, PhD

CONTACT

N

Nandini Rajgopal, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Healthy Lifestyles for Bipolar Disorder | DecenTrialz