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Healthy Lifestyles in Bipolar Disorder: Bay Area Study

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06555406 ist eine interventionsstudie zur Untersuchung von Bipolare Störung, Zeitlich begrenztes Essen und hat den Status offene rekrutierung. Die Studie startete am 22. November 2024 und soll 150 Teilnehmer aufnehmen. Durchgeführt von Universität von Kalifornien, Berkeley ist der Abschluss für 1. Februar 2029 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 26. November 2024 aktualisiert.
Kurzbeschreibung
The goal of this clinical trial is to understand how level of adherence with time-restricted eating (TRE) predicts change in diurnal rhythms (as measured using the amplitude of diurnal peripheral clock gene expression), and how those changes predict lower mania and depressive symptoms, and downstream improvements in quality of life. The effects of diurnal amplitude of clock gene expression is expected to remain significant when controlling for change in glucose tolerance and inflammation. Participants will be enrolled who are already receiving medication treatment for bipolar disorder. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow TRE for eight weeks. Symptoms and Quality of Life will be measured at baseline and during and after the food plan.
Ausführliche Beschreibung
This is a single-arm trial to examine the effects of time-restricted eating on change in diurnal rhythms, manic and depressive symptoms, and quality of life. In time-restricted eating (TRE), participants will be asked to limit their food intake to a period of 10 hours per day. TRE will be an addition to standard medication approaches in bipolar disorder. Participants who are receiving medical treatment for bipolar disorder and who report at least some sleep or circadian problems will complete baseline measures and then will be asked to follow TRE for 8 weeks, and then will complete measures of symptoms, Quality of Life, and possible treatment mechanisms at the mid-point of treatment, the end of treatment, and at 3 months after the intervention. If successful, this work will help understand key mechanisms through which TRE provides benefits for those with BD.
Offizieller Titel

Time-restricted Eating as an Adjunctive Intervention for Bipolar Disorder

Erkrankungen
Bipolare StörungZeitlich begrenztes Essen
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • TRE_Study2
NCT-Nummer
NCT06555406
Studienbeginn (tatsächlich)
2024-11-22
Zuletzt aktualisiert
2024-11-26
Studienende (vorauss.)
2029-02-01
Geplante Rekrutierung
150
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
sleep
insomnia
circadian rhythms
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellTime Restricted Eating (TRE) for 8 weeks
Participants will receive an intro to TRE and then throughout 8 weeks they will receive brief online psychoeducation several times per week with optional weekly coaching sessions. TRE involves restricting the window of eating to 10 hours/ day, most typically by avoiding eating in the first 1-2 hours after awakening and in the 2-4 before sleep. Those with an eating window \> 14 hours will be asked to restrict their eating to 12 hours in the first week, then 10 hours in week 2. To select the period, investigators will ask Ss to review baseline logs to consider sleep, eating, family meals and social commitment schedules, and any special energy demands, such as exercise. During the eating window, no restrictions are placed on the type or quantity of food consumed. The investigators will instruct participants to follow their habitual diet within their 10-hour eating window and to aim to consume the same number of calories per day as they did at baseline.
Time-restricted Eating for 8 Weeks
limiting food intake to 10 hours per day
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Mania
Young Mania Rating Scale (YMRS) total scores (minimum: 0, maximum: 60, high scores reflect higher manic symptom severity)
Lower YMRS at the end of intervention (10 weeks) as compared to baseline
Depression
Montgomery Asberg Depression Scale (MADRS) total scores (minimum: 0, maximum: 60, higher scores reflect higher depressive symptom severity)
Lower MADRS at the end of intervention (10 weeks) as compared to baseline
Self-rated Quality of Life (QOL)
self-rated Brief Quality of Life in Bipolar Disorder (QoL.BD) (minimum: 12, maximum: 60, higher scores reflect better QOL)
Scores at 1.5-months post-intervention (16 weeks) as compared to baseline
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Mania at follow-up
YMRS (described above) and Longitudinal Interval Follow-up Evaluation (LIFE; minimum 0, maximum 6) scores across follow-up (higher scores reflect more severe symptoms)
YMRS and LIFE scores will be lower at 3 months post-intervention as compared to baseline
Depression at follow-up
MADRS scores (described above) across follow-up
MADRS scores will be lower at 3 months post-intervention as compared to baseline
Self-rated mania
Patient Health Questionnaire (PMQ) Mania scores (minimum: 0, maximum: 27, higher scores reflect more severe mania)
Lower PMQ scores at post-intervention (10 weeks) and at 1.5 and 3 months follow-ups post-intervention, as compared to baseline
Self-rated depression
Patient Health Questionnaire (PHQ) Depression scores (minimum: 0, maximum: 27, higher scores reflect more severe depression)
post-intervention (10 weeks) and at 1.5 and 3 months follow-ups post-intervention, as compared to baseline
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.
immediately post-treatment (10 weeks after enrollment)
Weekly change in mania severity
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 6 months after study entry, and interviewers will record a mania severity rating for each week, to cover the time from the end of intervention until 6-month follow-up. Better outcomes would be reflected in lower LIFE scores post-treatment.
Weekly scores from the end of the intervention through 3 months post-intervention
Daily emotional lability as assessed using ecological momentary assessment
Mean square of successive difference of negative affect scores within derived from the ecological momentary assessments at 7 weeks post-baseline as compared to baseline. Participants will be asked to complete negative affect ratings 5 times per day for 7 days, at the baseline and mid-point of treatment. The investigators will calculate scores to examine the degree of negative affect variability for each day, and then take the average across 7 days at baseline and at treatment mid-point. Better outcomes would be indicated by lower scores.
7 weeks post-study entry as compared to baseline
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • Meets diagnostic criteria for bipolar I disorder or bipolar II disorder (but not cyclothymia, bipolar disorder Not otherwise specified or bipolar disorder due to another medical condition) assessed by the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and Related Neuropsychiatric Disorders [DIAMOND])
  • 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 the researchers 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.
  • Receiving medical care for bipolar disorder (referrals will be provided for those who would like to begin care)
  • Mood-stabilizing medication regimens stable for at least one month
  • < 5 kg weight change in the past 3 months
  • Currently eating ≥ 12 hours per day at least twice per week
  • Able to operate the camera function and respond to web-based surveys by phone (loaner phones will be provided as needed)
  • Not engaged in current shift work or have other responsibilities such as providing care that would chronically disrupt their sleep (i.e., > 3 h between 22:00 and 05:00 h for at least 1 day/week)
  • Able to complete 7 days of dietary logs adequately (e.g., at least 2 entries per day, covering at least a 5-hour eating window) during the baseline period
  • Able to complete screening and baseline questionnaires adequately (e.g., not failing more than 1 attention check item with instructed responding; responding to standard multiple-choice items in a mean of < 2 seconds per item). Where individuals respond to more than 14 items in a row with the same response, their answers will be manually reviewed for possible invalidity.

  • Current episode of depression, hypomania or mania, or psychosis (assessed by the 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
  • Conditions that would interfere with ability to take part in the intervention, including pregnancy, breastfeeding, uncorrected hypo or hyperthyroidism, gastrointestinal conditions impairing nutrient absorption
  • Conditions that would confound immune or other study measures, such as HIV, AIDS, lupus, or multiple sclerosis
  • Medications contraindicated for fasting: clozapine, glucose-lowering medications, diabetes-related injections, medications requiring food early morning or late evening, corticosteroids; Glucagon-like peptide-1 (GLP-1) agonists will not be an exclusion criteria if weight stabilized
  • Cognitive deficits as noted during the initial interview or as indicated by low performance on the Orientation Memory Concentration Test- Short Version (weighted score < 20)
University of California, Berkeley logoUniversität von Kalifornien, Berkeley51 aktive klinische Studien zum Erkunden
Zentrale Studienkontakte
Kontakt: Sheri L Johnson, PhD, (510) 519-4305, [email protected]
Kontakt: Nandini A Rajgopal, BS, (510) 519-4305, [email protected]
1 Studienstandorte in 1 Ländern

California

University of California Berkeley, Berkeley, California, 94720-2010, United States
Nandini Rajgopal, BS, Kontakt, 510-519-4305, [email protected]
Sheri L Johnson, PhD, Kontakt, (510) 519-4305, [email protected]
Sheri L Johnson, PhD, Hauptprüfer
Offene Rekrutierung