NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder
Recruiting · NCT05669703 · Observational (researchers observe without assigning treatment) · Lead sponsor: National Institute of Mental Health (NIMH)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Aged 8 and older
- Probands must have at least one first-degree relative agree to participate
- Affected probands must have a lifetime history of a mood disorder
- Unaffected probands must have no lifetime history of a mood disorder
- In good general health as evidenced by medical history
- Agreement to adhere to Lifestyle Considerations throughout study duration
- 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:
- Pregnancy
- People in acute episodes of mania or depression (not excluded, but will delay study entry until sufficiently managed to allow participation in study procedures).
Where it is running
2 locations listed across 1 US state.
- National Institutes of Health Clinical Center - Bethesda, Maryland, United States
- National Institutes of Health Clinical Center - Bethesda, Maryland, United States