Ignite Creation Date:
2024-05-06 @ 6:26 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05669703
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2022-12-30
Brief Title:
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
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
NIMH Rhythms and Blues Study A Prospective Natural History Study of Motor Activity Mood States and Bipolar Disorder
Status:
RECRUITING
Status Verified Date:
2024-08-14
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 A subset of the probands and relatives will participate in an outpatient andor 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 maniahypomania
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 05 13 12 and 24 hrs exercise
Tertiary Endpoints
Potential correlates of the association between motor activity and mood states including individual factors eg age sex comorbidity medical history physiologic factors eg heart rate cortisol light sensitivity cognitive factors eg performance on cognitive and neuroimaging tasks and environmental factors eg light season temperature
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 A subset of the probands and relatives will participate in an outpatient andor 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 maniahypomania
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 05 13 12 and 24 hrs exercise
Tertiary Endpoints
Potential correlates of the association between motor activity and mood states including individual factors eg age sex comorbidity medical history physiologic factors eg heart rate cortisol light sensitivity cognitive factors eg performance on cognitive and neuroimaging tasks and environmental factors eg light season temperature
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000754-M | None | None | None |