RecruitingNCT05669703

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


Sponsor

National Institute of Mental Health (NIMH)

Enrollment

1,260 participants

Start Date

Nov 3, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 8 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This long-term study from the National Institute of Mental Health (NIMH) tracks how physical activity patterns, sleep, and mood change over time in people with and without bipolar disorder. Participants wear activity monitors and complete mood diaries to help researchers understand the relationship between movement and mood. **You may be eligible if...** - You are 8 years of age or older - You have a personal or family history of a mood disorder (for one group) OR no history of mood disorders (for comparison group) - At least one first-degree family member also agrees to participate - You are in good general health **You may NOT be eligible if...** - You are unwilling to wear activity monitors or complete mood tracking for the duration of the study - You have a medical condition that would interfere with the study - No first-degree relative is willing to co-enroll Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT05669703


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