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

• ClinicalTrials.gov Identifier: NCT05669703
• Recruitment Status: Recruiting
• First Posted: January 3, 2023
• Last Update Posted: March 30, 2023
• Sponsor: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Study Description

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 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.

Condition or disease
Bipolar Disorder; Major Depression; Migraine

Detailed Description:

Study Description:

The overarching goal of this study is to investigate potential mechanisms underlying the association between motor activity and mood states and disorders. In a previous study using real-time tracking of objectively assessed motor activity and subjectively rated mood states with ecological momentary assessments (EMA), we found a unidirectional association between motor activity and mood that was especially notable among adults with bipolar I (BPI) disorder. The proposed study seeks to replicate these findings, and more extensively characterize the associations between motor activity and mood states by expanding the assessments of individual, physiologic, cognitive, and environmental correlates. This study will employ an intensive longitudinal design with combined ecological and laboratory assessments in the NIH Clinical Center in a sample of 280 probands with a lifetime history of bipolar I (BPI) disorder, bipolar II (BPII) disorder, major depressive disorder (MDD), or no lifetime history of a mood disorder. The study will also include up to 700 first-degree relatives (280 siblings and 420 offspring) and 280 spouses of the probands. About one-third (35%) of the probands, spouses and offspring will be randomly selected to participate in an inpatient component. The overarching hypothesis is that increases in motor activity, especially exercise, are associated with improvements in mood states. These findings will have implications for interventions in both the general community and clinical samples of people with mood disorders.

Objectives: The study has four specific aims:

1. Examine the associations between motor activity (using high resolution wearable sensors that are time-synchronized with EMA) and mood states in probands with a lifetime history of BPI disorder, BPII disorder, MDD, or no mood disorder (Multidomain Ecological Assessment).
2. Evaluate associations between motor activity and mood states among first-degree relatives and spouses of probands with and without BPI disorder, BPII disorder, MDD, or other mood disorder (Familial Patterns).
3. Quantify the impacts of exercise (a submaximal exercise test) on mood states and related domains by mood-disorder group in a controlled laboratory setting (Exercise).
4. Explore potential correlates of the association between motor activity and mood states (Correlates).

Endpoints:

Primary Endpoints:

1. Subjective mood and energy ratings assessed 4 times daily with EMA in ecological settings;
2. Scores on standardized questionnaires of mood and mania/hypomania;
3. Clinical rating scales;
4. Within subject and group level averages and variability.

Secondary Endpoints:

1. Subjective mood and energy ratings assessed with EMA before and after exercise;
2. Clinical rating scales;
3. Continuous heart rate measurements, blood pressure before and after (immediately, 0.5, 1,3, 12, and 24 hrs.) exercise.

Tertiary Endpoints:

Potential correlates of the association between motor activity and mood states including individual factors (e.g., age, sex, comorbidity, medical history), physiologic factors (e.g., heart rate, cortisol, light sensitivity), cognitive factors (e.g., performance on cognitive and neuroimaging tasks), and environmental factors (e.g., light, season, temperature).

Study Design

• Study Type: Observational
• Estimated Enrollment: 1260 participants
• Observational Model: Family-Based
• Time Perspective: Prospective
• Official Title: NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder
• Estimated Study Start Date: April 4, 2023
• Estimated Primary Completion Date: July 31, 2026
• Estimated Study Completion Date: July 31, 2026

Groups and Cohorts

Group/Cohort
1; Community cohort of families

Outcome Measures

Primary Outcome Measures :

1. Scores on standardized questionnaires [ Time Frame: Every 6 months ]
   Using standardized scales
2. Subjective mood and energy ratings [ Time Frame: 4x daily ]
   Using EMA
3. Clinical rating scales [ Time Frame: Every 6 months ]
   Using standardized scales

Secondary Outcome Measures :

1. Continuous heart rate measurements, blood pressure [ Time Frame: Before and after exercise ]
   Using standardized measures
2. Subjective mood and energy rating [ Time Frame: Before and after exercise ]
   Using EMA
3. Clinical rating scales [ Time Frame: Before and after exercise ]
   Using standardized scales

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 70 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

The sample will be recruited from several sources including: (1) our NIMH Family Study of Affective Spectrum Disorders; (2) ongoing clinical studies at NIH; and (3) volunteers from both clinical and community settings including the INOVA-Fairfax Health System, Medstar and the Johns Hopkins Health systems.

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 12-60
3. Probands must agree to direct evaluation (in either the outpatient or inpatient component) at the NIH Clinical Center
4. Probands must have at least one first-degree relative agree to participate
5. Affected probands must have a lifetime history of a mood disorder
6. Unaffected probands must have no lifetime history of a mood disorder
7. In good general health as evidenced by medical history
8. Agreement to adhere to Lifestyle Considerations throughout study duration
9. 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. Liver disease or ALT serum level greater than two times the laboratory upper limit of normal
2. Abnormal kidney function (eGFR<60 ml/min/1.73m^2)
3. Pregnancy
4. 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

Contacts

Contact: Alyssa T McGraw; (301) 496-1172; alyssa.mcgraw@nih.gov

Contact: Kathleen Merikangas, Ph.D.; (301) 496-7773; merikank@mail.nih.gov

Locations

United States, Maryland

National Institutes of Health Clinical Center; Recruiting

Bethesda, Maryland, United States, 20892

Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY dial 711 ccopr@nih.gov

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Kathleen Merikangas, Ph.D.; National Institute of Mental Health (NIMH)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page 

• Responsible Party: National Institute of Mental Health (NIMH)
• ClinicalTrials.gov Identifier: NCT05669703
• Other Study ID Numbers: 10000754; 000754-M
• First Posted: January 3, 2023
• Last Update Posted: March 30, 2023
• Last Verified: February 9, 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: .Our intention is to share aggregated data.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):

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

Additional relevant MeSH terms:

Disease; Bipolar Disorder; Pathologic Processes; Bipolar and Related Disorders; Mental Disorders