POTS24-006750

Submitted by fratecm on
Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Assessment of Environmental and Behavioral Rhythms on Youth Mood, Behavior, and Cognition
Contracting Office
National Institute of Mental Health (NIMH)

Contact Points

Primary Contract Specialist

Tam
Ngo
ngot@mail.nih.gov
NAICS Code Number
541715
The general purpose is to implement the concepts and procedures from studies in the Division of Intramural Research Programs (IRP) to translate the findings to youth mental health. The major goals of the IRP collaboration would be to advance the primary research goals of our research groups on mood disorders in order to identify links between mood disorders and their underlying dimensional manifestations with objective measures of motor activity and sleep, and mood reactivity and instability and broad outcomes including suicidal behavior, social and educational impairment, and onset of emotional and behavior disorders. Data from multiple domains including symptoms, impairment, neuroimaging, reactivity, psychophysiology, motor activity and sleep, cognitive function, and genetics that were collected in the first wave will be used to identify profiles of risk and outcome.
The specific goals of this proposed award will implement and quantify environmental light exposure and behavioral circadian measures to the existing collaboration between the IRP and Dr. Céline Vetter. In addition, Dr. Vetter will also continue to consult on ongoing analyses in the Motor Activity Research Consortium for Health (mMARCH) team that focus on individual and environmental exposures and their effects on chronotype, circadian biomarkers, actigraphy, sleep patterns, and mental health.

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

The contractor shall:
● Provide leadership and guidance for harmonization of environmental and behavioral rhythm data collection across study sites and study teams of the Rhythms & Blues Study protocols;
● Continue to provide train research coordinators on administration of light devices in the Healthy Brain Network Youth Component of the Rhythms & Blues Study and the Rhythms & Blues Study at the NIH Clinical Center study;
● Advise on environmental and behavioral rhythms data derivation across existing protocols, including actigraphy processing, light sensor data processing, and sleep pattern quantification.
Continue to aid in EMA adjustments to allow for monitoring of light device procedures and contextualization of continuous light exposure assessment for the Healthy Brain Network Youth Component of the Rhythms & Blues Study and the Rhythms & Blues Study at the NIH Clinical Center study;
● Advise on satellite and individual-level light exposure quantification in the mMARCH data;
● Advise on human melatonin rhythm assessment protocol for the NIH Clinical Center study;
● Advise on human light sensitivity assessments for the NIH Clinical Center study;
● Aid with integration of novel sleep and circadian biomarker methods into the Rhythms & Blues Study; and
● Implement the plans of light exposure and biomarker data analytic both with the Principal Investigator in the development of publication strategies and priorities and supervise project staff in the exploitation of the light, sleep, and circadian data as part of the Rhythms & Blues as well as the Motor Activity Research Consortium for Health (mMARCH) and manuscript preparation (literature review, peer-review response, general public communication).

Written Documentation: Dr. Vetter’s activities will be documented through a written final report. The contractor is required to provide a written report at the end of the contracting period. The report shall cover all work completed during the contract period. This report shall also identify any problems that arose and a statement explaining how the problem was resolved. This report shall also identify any problems that have arisen but have not been completely resolved and provide an explanation. Authorships on resulting papers will be agreed upon in advance.
Conference Calls: Communication will occur through regular email contact and monthly conference calls with the PI and other group calls as needed. Monthly calls will be organized by NIMH. These calls will be held to facilitate communication of progress and analytic plans.


LEVEL OF EFFORT:
During the period of performance of 12 months from the date of award, the contractor shall provide approximately 6 hours per month.


Small Business Size Standard
Not Small Business
Estimated Period of Performance
Period of performance of 12 months from the date of award
Set-Aside Status
Partial Set Aside
Competition Status
Brand Name Only
Vendor Name
Celine Vetter
Address
Dr. Céline Vetter
Kranichstr. 70
64569 Nauheim
celinevetter@gmail.com
Single-Sole Source Determination
I hereby determine that the work listed herein is available from only one source, and competition is precluded for the reasons indicated below. There are no substitutes available.
This acquisition is restricted to the following source:
Contractor: Dr. Celine Vetter
Contractor’s Address: Kranichstr. 70 64569 Nauheim
Contractor’s Email: celinevetter@gmail.com

Dr. Vetter’s research has focused on environmental drivers of sleep and circadian disruption and their role for health, including mental health. She is a recognized expert in quantification of circadian disruption and has big-data and epidemiology expertise which is unique for circadian scientists. As part of her work, Dr. Vetter leads observational and interventional investigations into the effects of environmental light patterns using light loggers in gaze direction. Dr. Vetter has received funding by the NIH, CU Boulder, and the Colorado Clinical and Translational Sciences Institute. Her work has also been embedded in large-scale epidemiological cohort studies such as the Nurses’ Health Studies, the UK Biobank, and the Hispanic Community Health Study/Study of Latinos. Prior to her tenure-track appointment as Assistant Professor at the University of Colorado Boulder, Dr. Vetter had an instructor faculty appointment at Harvard Medical School and served as an Associated Epidemiologist for Brigham and Women’s Hospital. Dr. Vetter is currently a senior consultant at IQVIA Commercial GmbH, Germany, and has collaborated with Dr. Merikangas and her team for over three and a half years now. Dr. Vetter has published more 85 peer-reviewed articles, including in JAMA, JACC, Nature Communications, Current Biology, and Diabetes Care.
Background/Description of Requirement

The NIMH Family Study is focused on mood disorders and its chief goals are to identify their diagnostic thresholds, subtypes, and boundaries with other disorders in order to identify the genetic and environmental risk factors for these conditions. The major research questions focus on the specificity of familial transmission of the mood disorder spectrum (i.e., symptoms, symptom clusters, subtypes) and the role of comorbidity with anxiety disorders and migraine in defining subtypes of mood disorders. Biologic factors underlying the major components of these disorders are studied in order to identify the core components of these conditions and familial endophenotypes that breed true in families, thereby more closely indexing the expression of underlying genes.
Light exposure is a modifiable environmental exposure that has been associated with mental health, cognition, and behavior, mediated in part through its impact on circadian function. This award will include consultation to include gold standard melatonin rhythms assessments that are considered key to understanding human circadian physiology. In addition, novel biomarker approaches are now available to identify potential mediators such as circadian phase, and its inclusion in the Rhythms & Blues Study will provide important biological insights into mediators of the physiological effects of light on cognition, behavior, and mood. Successful biomarker implementation will also be an essential proof of principle for scalability of future objective circadian phenotyping in larger-scale studies. Light exposure prior to the Rhythms & Blues Study at the NIH Clinical Center will be assessed with light sensors, also used in the Healthy Brain Network Youth Component, and which have been integrated in the protocols in close consultation with Dr. Vetter. Dr. Vetter will continue to provide leadership and guidance to the research teams across all study sites with regards to light device set-up, administration, and processing, ensuring quality light exposure assessment. To contextualize environmental light exposure assessments, the team will continue to adapt current Ecological Momentary Assessments (EMAs) as necessary and will thus be included in this award.

Dr. Vetter will also provide leadership and oversight for research teams across study sights to guide data processing, both for existing and to-be-collected environmental and behavioral rhythm data. Specifically, she will support the development of coding and processing procedures for existing Healthy Brain Network actigraphy data, in close collaboration with Dr. Merikangas’ team and her consultants.

Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.

All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.