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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
8 Years to 70 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years, 20 days, 3 days
  • Procedures mentioned: Urine samples, Physical exams, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Twice during the study, for 3 days in a row, they will: Wear monitors to record their temperature, heart rate, and sleep."
  • "They will have a physical exam, with blood and urine tests."
  • "Scores on standardized questionnaires of mood and mania/hypomania; 3."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how physical activity, sleep, and mental health are linked. It includes people with mood disorders, such as bipolar disorder, and people without mood disorders, including healthy spouses and relatives. Taking part may last up to 2 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • The detailed rules say age 8 or older, but the study overview lists ages 8 to 60.
  • Be willing and able to follow study steps for the full study.
  • If you are the main person enrolled in a family, at least one parent, sibling, or child must also agree to join.
  • For the mood disorder group, have had a mood disorder at some point in your life.
  • For the group without mood disorders, have never had a mood disorder.
  • Be in good general health based on your medical history.
  • Agree to follow the study’s lifestyle rules throughout the study.
  • You or your legally authorized representative must understand the study and be willing to sign a consent form.

Who can't join

  • Being pregnant.
  • A current episode of mania (very high or overly active mood) or depression will delay entry until it is managed well enough to take part. It does not permanently rule you out.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* 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).

Study sites (1)

MD