Bipolar Disorder / Major Depression / Migraine · Observational Study

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

ClinicalTrials.gov · August 13, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a prospective observational natural history study registration (not yet reporting results) designed to investigate relationships among physical activity, sleep, and mental health in people aged 8–60 with a history of mood disorders and healthy controls. The study employs intensive multimodal measurement including wearable sensors, ecological momentary assessment via smartphone diaries, and clinical assessments over 2 years, but no outcome data are currently available in this registry record.

What was studied

Observational. Bipolar Disorder, Major Depression, Migraine; age from 8 Years; to 70 Years; accepts healthy volunteers. Intervention: 1. Compared with: Healthy relatives and spouses without mood disorder history serve as comparison group within the observational cohort.. n = 1,260. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a prospective natural history study registration with no results reported; it describes planned enrollment and measurement methods for understanding relationships among physical activity, sleep, and mood disorders.

Study design

As stated by the source record.

MethodsFamily Based model. Prospective time perspective. Primary outcome measures: Scores on standardized questionnaires (assessed at Every 6 months); Subjective mood and energy ratings (assessed at 4x daily); Clinical rating scales (assessed at Every 6 months)

DesignObservational

PopulationBipolar Disorder, Major Depression, Migraine; age from 8 Years; to 70 Years; accepts healthy volunteers

Sample size1,260

Intervention1

ComparatorHealthy relatives and spouses without mood disorder history serve as comparison group within the observational cohort.

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment1260

Study durationup to 2 years

Age range8 to 60 years

Primary outcome measure 1Scores on standardized questionnaires, every 6 months

Primary outcome measure 2Subjective mood and energy ratings, 4x daily

Primary outcome measure 3Clinical rating scales, every 6 months

Caveats

This is a registry record; no results are reported and study recruitment is ongoing.
No outcome data, effect sizes, or clinical findings are available for assessment.
No information on analysis plan, statistical power, or primary hypothesis specification in registry text.
Generalizability limited by enrollment of both affected individuals and healthy relatives; mixed-age cohort (8–60 years) may limit interpretation.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Prospective observational natural history design with multimodal measurement (wearables, diaries, clinical assessments).

Directness

moderate

Directly measures physical activity, sleep, and mood in people with and without mood disorders.

Consistency

insufficient

Registry record only; no results reported for consistency assessment.

Risk of bias

insufficient

Study not yet complete; no methods for blinding or analysis control described in registry.

Sample adequacy

moderate

Planned enrollment 1260 participants; mixed population including those with and without mood disorders.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05669703). This is a study registration, not published results. Lead sponsor: National Institute of Mental Health (NIMH). Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 1260 participants (ESTIMATED). Conditions: Bipolar Disorder, Major Depression, Migraine. Primary outcome measures: Scores on standardized questionnaires , Every 6 months; Subjective mood and energy ratings , 4x daily; Clinical rating scales , Every 6 months. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Bipolar DisorderNational Institute of Mental Health (NIMH)Major DepressionNCT05669703Migraine