Mind/Body Research Program; Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2000 funds for a grant to conduct mind/body research.

CDC is committed to achieving the health promotion and disease prevention objectives of “Healthy People 2010” a national activity to reduce morbidity and mortality and improve the quality of life. This announcement is related to the focus areas of Disability and Secondary Conditions, and Physical Activity and Fitness. Other health objectives for the nation can ultimately be addressed through mind/body research because approaches that evoke the relaxation response may impact positively on a variety of chronic health conditions and disabilities targeted by the 2010 objectives.

For the conference copy of “Healthy People 2010”, visit the internet site: <http://www.health.gov/healthypeople>.

The purpose of this program is to generate knowledge through basic and clinical research about the effectiveness of a relaxation or stress reduction approach such as meditation or progressive muscle relaxation that evokes changes in psychophysiology and can, consequently, impact positively on physical and mental health. These psychophysiology outcomes, collectively labeled the relaxation response, include decreased heart rate, blood pressure, muscle tension, metabolism, breathing rate, and brain wave activity. Project objectives and activities should add to the literature, and include those that articulate the acute (changes that occur as a result of a single session) and chronic (changes that occur as a result of numerous sessions repeated over time) benefits of an approach that evokes the relaxation response. Such efforts should be highlighted by identifying and advancing knowledge about the causal mechanisms underlying the neural and systemic adaptations that trigger the relaxation response (e.g., acute transient change in systolic and diastolic blood pressure) and related chronic health outcomes (e.g., reductions in resting systolic and diastolic blood pressure in patients with hypertension). In addition, a goal of this project should be to identify determinants or correlates that assist in predicting who will initiate, maintain, and benefit from an approach that evokes the relaxation response. In this regard, identifying and understanding how important sociodemographic variables, health status and belief systems, influence use and effectiveness of an approach that evokes the relaxation response are desired study outcomes.

Numerous medical conditions, including hypertension, pain, and stress related mood disturbance, have responded favorably to treatment using approaches that evoke the relaxation response. Little is known about the processes that account for the improvements in health. This project requires that multi-disciplinary and well controlled study(ies) with healthy or clinical populations be conducted to investigate the physiological basis for treatment of modality effectiveness, as well as psychosocial attributes influencing successful treatment response.

B. Eligible Applicants

Applications may be submitted by public and private nonprofit organizations and by governments and their agencies; that is, universities, colleges, research institutions, hospitals, other public and private nonprofit organizations, State and local governments or their bona fide agents, and federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations.

Applicants must provide proof of their non-profit status. See Attachment I for additional requirements.

Note:

Public Law 104-65 states that an organization described in section 501(c)(4) of the Internal Revenue Code of 1986 that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, cooperative agreement, contract, loan, or any other form.

C. Availability of Funds

Approximately $862,000 will be available in FY 2000 to fund one award. It is expected that the awards will begin on or about September 30, 2000 and will be made for a 12-month budget period within a project period of up to three years. Funding estimates may change.

Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

D. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the following:

1. Identify a manager/coordinator with the authority and responsibility to conduct and manage all components of the project.

2. Create the capacity to attract and motivate persons to initiate and maintain research interventions/protocols.

3. Variables included in the program are dependent on the acute or chronic research questions. Study variables may include blood pressure measures, muscle tension/electromyographic activity (EMG), signaling molecules, biochemical markers and immunologic profiles characteristic of the relaxation response, electroencephalographic measures (EEG), functional magnetic resonance imaging (fMRI), measures of heart rate/heart rate fluctuations, and pain measures, as well as valid and reliable, state or trait psychometric measures (e.g., measures of belief systems, spirituality, depression, anxiety).

4. Evaluate the causal mechanisms and effectiveness of a relaxation approach which evokes psychophysiological changes (collectively known as the relaxation response), that can, consequently, maintain or improve physical and/or mental health in one or more select populations (e.g., healthy older adults [e.g., 50 and above years of age], or persons with a chronic disease/disability or mood disturbance [e.g., arthritis, cancer, diabetes, depression or anxiety disorders]).

a. Identify, and advance the knowledge related to, the acute psychophysiological response(s) and reliability of the response(s) that occur as a result of a single relaxation session (i.e., to identify novel outcomes or new knowledge about already known outcomes).

b. Identify, and advance the knowledge related to, chronic psychophysiological responses (health promotion/disease prevention benefits) that occur as a result of involvement in multiple “relaxation” sessions repeated over a period of time (i.e., to identify novel outcomes or new knowledge about already known outcomes).

c. Identify and describe the underlying processes, trigger, or causal mechanisms that mediate the relaxation approach, relaxation response and related health outcomes relationships.

5. Evaluate, and ultimately identify and describe characteristics (determinants/correlates) of those who initiate, adhere to, and benefit from, an approach which evokes the relaxation response; to include subject attributes such as belief systems, healthy versus chronic disease patients, gender, age, and race/ethnicity.

6. Publish the results of the research in journals and etc.

E. Application Content

Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed, so it is important to follow them in laying out the program plan. The narrative addressing the scored criteria should be no more than 25 double-spaced pages, printed on one side, with one inch margins, and unreduced font. The application should be organized in the following sections.

1. Executive Summary

Provide a clear and concise written statement of the project's purpose and major objectives, an outline of the major activities, and a time line of key milestones.

2. Problem Statement and Evidence of Need

a. Describe the literature and demonstrate how mind (cognition) and body (physiology) interact.

b. Describe the impact on one or more health outcomes.

c. Synthesize state-of-the-art findings regarding the effectiveness of an approach that evokes the relaxation response that has been used with healthy persons and/or persons with chronic disease or disability, including documentation/referencing of the applicants own systematic and ongoing line of mind/body inquiry as evidenced by publications and/or presentations at professional scientific meetings.

d. Describe the unmet needs and information gaps as they relate to advancing a coordinated and comprehensive effort to promote health through the relaxation response, and how this project would move toward addressing these needs and gaps (i.e., purpose of the project).

3. Research Resources and Organizational Capacity

a. Describe the applicant's capability to conduct the project, taking into account its institutional experience, evidence of leadership, and ability to successfully do multi-disciplinary research for those activities required.

b. Describe the applicant's ability to attract and retain subjects such as establishing collaborations with one or more community-based partner(s) (health maintenance organizations; health clinics; foundations, schools) that can serve as a subject/patient/client referral source.

c. Describe the applicant's capacity to provide evidence of effective collaborations and linkages with partners, to meet the requirements of the project, including, if warranted, documented letters of support and commitments from those collaborating entities.

d. Describe the capacity of the applicant to gather necessary confidential, demographic and health outcome information regarding the study participants' characteristics that predict engaging in, maintaining, and/or benefitting from a relaxation approach, including the kinds and sources of information to be obtained, analyzed, and publicized, the staff/organizations charged with its control, and how these data would be protected and used.

4. Operational Approach

a. Describe the research question(s) (that will advance the knowledge), scientific methods, and data analyses to be employed to assess the acute psychophysiological responses/benefits (e.g., immediate but transient blood pressure reductions), and reliability of responses, associated with a relaxation approach, including a theoretical or scientific rationale for the measures selected and, when appropriate, evidence of the validity and reliability of measures selected (e.g., measures of state anxiety).

b. Describe the research question(s) (that will advance the knowledge), scientific methods, and data analyses to be employed to evaluate the chronic (e.g., reduction in resting blood pressure in patients with hypertension) health outcomes associated with a relaxation approach, including a theoretical or scientific rationale for the outcomes or variables selected and, when appropriate, evidence of the validity and reliability of measures selected.

c. Describe the scientific methods to evaluate the hypothesized causal mechanisms that mediate the relaxation approach, relaxation response, and health outcomes relationship(s).

d. Describe the approach to (1) gather information on the determinants related to initiating, maintaining, and benefitting from a relaxation approach, including a brief review of currently available evidence, and/or plans to collect and analyze data that leads to an understanding of correlates which may predict who is attracted to initiating a relaxation approach, adherence rates to a relaxation approach, and the benefits gained (based on factors such as sociodemographic characteristics, health status, and one or more assessments related to belief systems, positive or negative affect, or other pertinent constructs); and (2) assess the perceptions, outcome expectancies, enjoyment, and/or actual response(s) or outcomes of persons based on their status as novice or experienced practitioners of a relaxation approach.

5. Management Plan and Project Goals and Objectives

a. Present a management work plan for conducting the project, including the process (approach and methods) by which the applicant will meet established goals and objectives.

b. Provide a description of specific goals, objectives and time lines.

c. Provide a description of the major tasks and responsibilities for key positions including the applicant organization (include an organization chart and denote the relationship of this project within the applicant organization).

d. Describe how the applicant will evaluate its work plan, all collaborations, and activities related to the scope of the project.

6. Budget Justification

Provide a line-item budget with a detail narrative justification that is consistent with the purpose and objectives of this grant.

7. Human Subjects Research

Adequately address the requirements of Title 45CFR Part 46 for the protection of human subjects.

F. Submission and Deadline

Submit the original and two copies of PHS-398 (OMB Number 0925-0001) (adhere to the instructions on the Errata Instruction Sheet for PHS-398). Forms are in the application kit.

On or before July 14, 2000, submit the application to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement. Deadline: Applications shall be considered as meeting the deadline if they are either:

(a) Received on or before the deadline date; or

(b) Sent on or before the deadline date. (Applicants must request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing.)

Late Applications: Applications which do not meet the criteria in (a) or (b) above are considered late applications, will not be considered, and will be returned to the applicant.

G. Evaluation Criteria

Each application will be evaluated individually against the following criteria by an independent review group appointed by CDC.

1. Problem Statement and Evidence of Need—20 Points

This includes the degree to which the applicant:

a. Describe (1) the literature demonstrating how mind (cognition) and body (physiology) interact, and (2) impact on one or more health outcomes.

b. Synthesizes state-of-the-art findings regarding the effectiveness of an approach that evokes the relaxation response that has been used with healthy persons and/or persons with chronic disease or disability, including documentation/referencing of the applicants own systematic and ongoing line of mind/body inquiry as evidenced by publications and/or presentations at professional scientific meetings.

c. Describes the unmet needs and information gaps as they relate to advancing a coordinated and comprehensive effort to promote health through the relaxation response, and how this project would move toward addressing these needs and gaps (i.e., purpose of the project).

2. Research Resources and Organizational Capacity—15 points

a. The capability of the applicant to conduct the project, taking into account its institutional experience, evidence of leadership, and ability to successfully do multi-disciplinary research for those activities required.

b. The ability of the applicant to attract and retain subjects such as establishing collaborations with one or more community-based partner(s) (health maintenance organizations; health clinics; foundations, schools) that can serve as a subject/patient/client referral source.

c. The capacity of the applicant to provide evidence of effective collaborations and linkages with partners, to meet the requirements of the project, including, if warranted, documented letters of support and commitments from those collaborating entities.

d. The capacity of the applicant to gather necessary confidential, demographic and health outcome information regarding the study participants' characteristics that predict engaging in, maintaining, and/or benefitting from a relaxation approach, including the kinds and sources of information to be obtained, analyzed, and publicized, the staff/organizations charged with its control, and how these data would be protected and used.

3. Operational Approach—(Total 50 Points)

a. Describe the research question(s) (that will advance the knowledge), scientific methods, and data analyses to be employed to assess the acute psychophysiological responses/benefits (e.g., immediate but transient blood pressure reductions), and reliability of responses, associated with a relaxation approach, including a theoretical or scientific rationale for the measures selected and, when appropriate, evidence of the validity and reliability of measures selected (e.g., measures of state anxiety). (10 points)

b. The research question(s) (that will advance the knowledge), scientific methods, and data analyses to be employed to evaluate the chronic (e.g., reduction in resting blood pressure in patients with hypertension) health outcomes associated with a relaxation approach, including a theoretical or scientific rationale for the outcomes or variables selected and, when appropriate, evidence of the validity and reliability of measures selected. (10 points)

c. The scientific methods to evaluate the hypothesized causal mechanisms that mediate the relaxation approach, relaxation response, and health outcomes relationship(s). (20 points)

d. The approach to (1) gather information on the determinants related to initiating, maintaining, and benefitting from a relaxation approach, including a brief review of currently available evidence, and/or plans to collect and analyze data that leads to an understanding of correlates which may predict who is attracted to initiating a relaxation approach, adherence rates to a relaxation approach, and the benefits gained (based on factors such as sociodemographic characteristics, health status, and one or more assessments related to belief systems, positive or negative affect, or other pertinent constructs); and (2) assess the perceptions, outcome expectancies, enjoyment, and/or actual response(s) or outcomes of persons based on their status as novice or experienced practitioners of a relaxation approach. (10 points)

4. Management Plan and Project Goals and Objectives—15 Points

a. The management work plan for conducting the project, including the process (approach and methods) by which the applicant will meet established goals and objectives.

b. The presentation of those specific goals, objectives and time lines.

c. The description of the major tasks and responsibilities for key positions including the applicant organization (include an organization chart and denote the relationship of this project within the applicant organization).

d. The description of how the applicant will evaluate his/her work plan, all collaborations, and activities related to the scope of the project.

e. The degree to which the applicant has met the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes:

(1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation.

(2) The proposed justification when representation is limited or absent.

(3) A statement as to whether the design of the study is adequate to measure differences when warranted.

(4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits.

5. Budget Justification—Not Scored

This criteria includes the adequacy of the budget justification and its relationship to program operations and services. Each line item of the budget must be well justified in a detailed narrative with special attention given to contractual requests including the responsibilities of consultants, percentage time equivalents, hourly or daily rates, etc.

The relevance of this section to the other evaluation criteria will be measured on the extent to which the budget narrative is reasonable, clearly documented, accurate, and consistent with the purpose of this announcement.

6. Human Subjects—Not Scored

Does the application adequately addresses the requirements of Title 45 CFR Part 46 for the protection of human subjects?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. Annual progress reports;

2. Financial status report, due no more than 90 days after the end of each budget period; and

3. Final financial status and performance reports, due no more than 90 days after the end of the project period.

Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I in the application kit.

AR-1 Human Subjects Requirements

AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

AR-8 Public Health System Reporting Requirements

AR-9 Paperwork Reduction Act Requirements

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

AR-12 Lobbying Restrictions

AR-14 Accounting Systems Requirements

AR-15 Proof of Non-Profit Status

I. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under the sections 301(a) and 317(k)(2) the Public Health Service Act, (42 U.S.C. 241(a) and 247b(k)(2)), as amended. The Catalog of Federal Domestic Assistance number is 93.283.

J. Where to Obtain Additional Information

This announcement and other CDC program announcements can be found on the CDC home page Internet address: http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.”

To obtain additional information, contact: Cynthia Collins, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Announcement 000118, Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, Room 3000 Atlanta, GA 30341-4146, telephone (770)-488-2757, E-mail: coc9@cdc.gov.

For program technical assistance, contact: Deborah Jones, Division of Nutrition and Physical Activity, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Highway, Atlanta, GA 30341-3724, telephone (770) 488-5593, E-mail address: DAJones@cdc.gov.