RECRUITING

NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 12 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.

Official Title

NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder

Quick Facts

Study Start:2023-11-03
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05669703

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Stated willingness to comply with all study procedures and availability for the duration of the study
  2. 2. Aged 12 and older
  3. 3. Probands must have at least one first-degree relative agree to participate
  4. 4. Affected probands must have a lifetime history of a mood disorder
  5. 5. Unaffected probands must have no lifetime history of a mood disorder
  6. 6. In good general health as evidenced by medical history
  7. 7. Agreement to adhere to Lifestyle Considerations throughout study duration
  8. 8. Ability of subject (or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.
  1. 1. Pregnancy
  2. 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).

Contacts and Locations

Study Contact

Kathleen Merikangas, Ph.D.
CONTACT
(301) 496-7773
familystudy@nih.gov

Principal Investigator

Kathleen Merikangas, Ph.D.
PRINCIPAL_INVESTIGATOR
National Institute of Mental Health (NIMH)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Mental Health (NIMH)

  • Kathleen Merikangas, Ph.D., PRINCIPAL_INVESTIGATOR, National Institute of Mental Health (NIMH)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-03
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2023-11-03
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • Mood Disorders
  • Actigraphy
  • CIRCADIAN RHYTHMS
  • Sleep
  • Ecological Momentary Assessments
  • Natural History

Additional Relevant MeSH Terms

  • Bipolar Disorder
  • Major Depression
  • Migraine