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NIMH Rhythms and Blues Study: Eine prospektive naturgeschichtliche Studie über Biorhythmen und Reaktivität

6. Oktober 2026 aktualisiert von: National Institute of Mental Health (NIMH)

Background:

Mood disorders, such as bipolar disorder, can have serious effects on a person s life. People with bipolar disorder are more likely to have heart disease and abuse substances. In this natural history study, researchers would like to learn more about the connection between exercise and mental health in people with and without mood disorders.

Objective:

To better understand relationships among physical activity, sleep, and mental health.

Eligibility:

People aged 8 to 60 years with a history of a mood disorder. Healthy spouses and relatives with no mood disorders are also needed.

Design:

Participants will be in the study up to 2 years.

For up to 20 days in a row, at 4 times during the study, participants will:

Complete an electronic diary on their smartphone. Participants will answer questions about their mood, health, sleep, and daily activities.

Wear an activity monitor, like a wristwatch, that records how much they move.

Wear a light sensor, as a necklace, to record the amount of light in their environment.

Some participants will do additional tests. Twice during the study, for 3 days in a row, they will:

Wear monitors to record their temperature, heart rate, and sleep.

Provide saliva samples.

Complete cognitive tasks on their smartphone.

Participants will visit the NIH clinic 2 times. They will have a physical exam, with blood and urine tests. They will wear a heart monitor. They will ride a stationary bike for 30 minutes. They may have an imaging scan.

Some participants will stay overnight. They will go to sleep wearing a cap to measure their brain activity.

Studienübersicht

Status

Rekrutierung

Detaillierte Beschreibung

Study Description:

The overarching goal of this study is to investigate potential mechanisms underlying the association between motor activity and mood states and disorders. In a previous study using real-time tracking of objectively assessed motor activity and subjectively rated mood states with ecological momentary assessments (EMA), we found a unidirectional association between motor activity and mood that was especially notable among adults with bipolar I (BPI) disorder. The proposed study seeks to replicate these findings, and more extensively characterize the associations between motor activity and mood states by expanding the assessments of individual, physiologic, cognitive, and environmental correlates. This study will employ an intensive longitudinal design with combined ecological and laboratory assessments in the NIH Clinical Center in a sample of 280 probands with a lifetime history of bipolar I (BPI) disorder, bipolar II (BPII) disorder, major depressive disorder (MDD), or no lifetime history of a mood disorder. The study will also include up to 700 first-degree relatives (280 siblings and 420 offspring) and 280 spouses of the probands. A subset of the probands and relatives will participate in an outpatient and/or inpatient component. The overarching hypothesis is that increases in motor activity, especially exercise, are associated with improvements in mood states. These findings will have implications for interventions in both the general community and clinical samples of people with mood disorders.

Objectives: The study has four specific aims:

  1. Examine the associations between motor activity (using high resolution wearable sensors that are time-synchronized with EMA) and mood states in probands with a lifetime history of BPI disorder, BPII disorder, MDD, or no mood disorder (Multidomain Ecological Assessment).
  2. Evaluate associations between motor activity and mood states among first-degree relatives and spouses of probands with and without BPI disorder, BPII disorder, MDD, or other mood disorder (Familial Patterns).
  3. Quantify the impacts of exercise (a submaximal exercise test) on mood states and related domains by mood-disorder group in a controlled laboratory setting (Exercise).
  4. Explore potential correlates of the association between motor activity and mood states (Correlates).

Endpoints:

Primary Endpoints:

  1. Subjective mood and energy ratings assessed 4 times daily with EMA in ecological settings;
  2. Scores on standardized questionnaires of mood and mania/hypomania;
  3. Clinical rating scales;
  4. Within subject and group level averages and variability.

Secondary Endpoints:

  1. Subjective mood and energy ratings assessed with EMA before and after exercise;
  2. Clinical rating scales;
  3. Continuous heart rate measurements, blood pressure before and after (immediately, 0.5, 1,3, 12, and 24 hrs.) exercise.

Tertiary Endpoints:

Potential correlates of the association between motor activity and mood states including individual factors (e.g., age, sex, comorbidity, medical history), physiologic factors (e.g., heart rate, cortisol, light sensitivity), cognitive factors (e.g., performance on cognitive and neuroimaging tasks), and environmental factors (e.g., light, season, temperature).

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

1260

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

    • Maryland
      • Bethesda, Maryland, Vereinigte Staaten, 20892
        • Rekrutierung
        • National Institutes of Health Clinical Center
        • Kontakt:
          • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
          • Telefonnummer: TTY dial 711 800-411-1222
          • E-Mail: ccopr@nih.gov

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

8 Jahre bis 70 Jahre (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

The sample will be recruited from several sources including: (1) our NIMH Family Study of Affective Spectrum Disorders; (2) ongoing clinical studies at NIH; and (3) volunteers from both clinical and community settings including the INOVA-Fairfax Health System, Medstar and the Johns Hopkins Health systems.

Beschreibung

  • INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Stated willingness to comply with all study procedures and availability for the duration of the study
  2. Aged 8 and older
  3. Probands must have at least one first-degree relative agree to participate
  4. Affected probands must have a lifetime history of a mood disorder
  5. Unaffected probands must have no lifetime history of a mood disorder
  6. In good general health as evidenced by medical history
  7. Agreement to adhere to Lifestyle Considerations throughout study duration
  8. Ability of subject (or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

The presence of certain medical conditions may interfere with the interpretation or increase risk of medical complications of the assessments including exercise. Therefore, an individual who meets any of the following criteria will be excluded from participation in this study:

  1. Pregnancy
  2. People in acute episodes of mania or depression (not excluded, but will delay study entry until sufficiently managed to allow participation in study procedures).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: FAMILY_BASED
  • Zeitperspektiven: PROSPECTIVE

Kohorten und Interventionen

Gruppe / Kohorte
1

Community cohort of families

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Scores on standardized questionnaires
Zeitfenster: Every 6 months

Using standardized scales

Every 6 months
Subjective mood and energy ratings
Zeitfenster: 4x daily

Using EMA

4x daily
Clinical rating scales
Zeitfenster: Every 6 months

Using standardized scales

Every 6 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Continuous heart rate measurements, blood pressure
Zeitfenster: Before and after exercise

Using standardized measures

Before and after exercise
Subjective mood and energy rating
Zeitfenster: Before and after exercise

Using EMA

Before and after exercise
Clinical rating scales
Zeitfenster: Before and after exercise

Using standardized scales

Before and after exercise

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Kathleen R Merikangas, Ph.D., National Institute of Mental Health (NIMH)

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

3. November 2023

Primärer Abschluss (Geschätzt)

31. Juli 2027

Studienabschluss (Geschätzt)

31. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

30. Dezember 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. Dezember 2022

Zuerst gepostet (Tatsächlich)

3. Januar 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Oktober 2026

Zuletzt verifiziert

5. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Beschreibung des IPD-Plans

Our intention is to share aggregated data.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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