Full Text PA-95-056

BIOBEHAVIORAL PAIN RESEARCH

NIH GUIDE, Volume 24, Number 15, April 28, 1995

PA NUMBER:  PA-95-056

P.T. 34

Keywords: 
  Behavioral/Experimental Psychology 
  Pain 
  Psychology 
  Genetics 
  Neuroscience 
  Endocrinology 


National Institute of Nursing Research
National Institute of Dental Research
National Institute on Aging
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Cancer Institute
National Institute of Child Health and Human Development
National Institute on Drug Abuse
National Heart, Lung, and Blood Institute
National Institute of Mental Health
National Institute of Neurological Disorders and Stroke
Office of Alternative Medicine

PURPOSE

The purpose of this biobehavioral pain research program announcement
is to inform the scientific community of the interests of the various
institutes at the National Institutes of Health (NIH) and to
stimulate and foster a wide range of basic and clinical studies on
pain as they relate to the missions of these Institutes.
Applications are encouraged to study individual differences in pain
responses which may be due to factors such as genetic differences,
endocrine activity, neural activity, immune function, psychological
state, disability state, age, gender, and cultural background.
Research is also needed in areas such as understanding the
neuroanatomical pathways and the neurophysiological mechanisms in
pain.  The pain experience needs to be examined at all levels of
research including the gene, molecule, cell, organ, and individual
with the goal of developing biobehavioral interventions to manage or
prevent pain.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This PA,
"Biobehavioral Pain Research," is related to the priority areas of
chronic disabling conditions, cancer, and clinical prevention
services.  Potential applicants may obtain a copy of "Healthy People
2000" (Full Report:  Stock No. 017- 001-00474-0) or "Healthy People
2000" (Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and domestic, for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.
Foreign institutions are not eligible for First Independent Research
Support and Transition (FIRST) awards (R29).

MECHANISM OF SUPPORT

The mechanisms of support will be the research project grant (R01)
and the FIRST award (R29).  Additionally, some institutes will use
the small research grant (R03) mechanism; applicants are advised to
contact the program official listed under INQUIRIES for information.
Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.  Awards will
be administered under PHS grants policy as stated in the Public
Health Service Grants Policy Statement (April 1, 1994).

RESEARCH OBJECTIVES

Pain is a critical national health problem.  It is the most common
reason for medical appointments, nearly 40 million visits annually,
and costs this country over $100 billion each year in health care and
lost productivity.  Pain has a profound effect on the quality of
human life.  In addition to possible deleterious effects on immune
function, pain can cause disruptions in sleep, eating, mobility, and
overall functional status.  In the hospitalized patient, pain may be
associated with increased length of stay, longer recovery time, and
poorer patient outcomes, all of which have health care quality and
cost implications.

Progress is being made in understanding the neuroanatomical pathways
and the neurophysiological and neurochemical mechanisms involved in
pain.  However, understanding the subjective pain experience in
individuals presents unique scientific challenges.  Even though the
basic physiology may be similar, people react in very different ways,
perhaps due to genetic differences, endocrine activity, neural
activity, immune function, stress, psychological state, age, gender,
and cultural background.  Thus, the pain experience needs to be
examined at all levels of basic and clinical research, including the
gene, molecule, cell, organ, and individual, with the goal of
developing biobehavioral interventions to manage or prevent pain.

In order to develop a research agenda, ten NIH institutes sponsored a
workshop, "Biobehavioral Pain Research:  A Multi-Institute Assessment
of Cross-Cutting Issues and Research Needs," in January 1994.  This
meeting, under the aegis of the NIH Health and Behavior Coordinating
Committee, resulted in the identification of research needs from a
broad spectrum of the scientific community expert in pain research.

The following pain research areas cut across Institutes and programs
and should not be viewed as restricted to only one specific
Institute.  Current NIH referral guidelines will be used to assign
grant applications to the most appropriate NIH Institute based on the
scientific focus of the application.

The following topics and study areas are not intended to be
comprehensive or exclusive:

Understanding Critical Interfaces Between Biology and Behavior

o  Explore the neural basis of pain perception and discover targets
in the signal transduction pathways that may be the most effective
points for interventions in the control of pain across the lifespan.

o  Examine the neuroendocrine and immunological correlates of pain.

o  Investigate both pharmacological and behavioral interventions to
prevent pain.

o  Refine neuroimaging algorithms for the study of structural and
functional correlates of pain perception.

o  Conduct animal and human studies on the temporal patterning of
pain.

o  Explore the basic developmental aspects of pain processing,
including an integration of psychological, neurochemical, and
molecular approaches which could impact the treatment of pain across
the life span.

o  Identify genes relevant to pain and pain inhibitory mechanisms.

o  Examine the role of placebo effect in pain treatment.

Pain, Suffering, and Emotion

o  Explore basic mechanisms of the conscious perception of pain and
the affective responses to pain.

o  Examine the relative importance of biological, socioenvironmental,
and psychological variables in explaining variations in pain-
expressive behaviors.

o  Clarify the relationship between depression and chronic pain by
elucidating the biological factors, characteristics of the pain
(e.g., location, quality, timing), environmental circumstances, and
personal characteristics that are predictive of this relationship.

o  Elucidate emotions and emotional disturbances, in addition to
depression, (e.g., anger, fear, anxiety) which are associated with
acute and chronic pain conditions, and determine how these emotions
modify the experience of pain.

Pain and Behavior

o  Explore the sensory, cognitive, and affective aspects of acute and
chronic pain across the lifespan.

o  Elucidate the interaction of biological markers, central nervous
system mechanisms, and drug and behavioral interventions.

o  Determine the relative contributions of biological, psychological,
behavioral, and environmental predictors of the course of pain, pain
dysfunction, and response to treatment for pain.

o  Examine addiction risk in patients taking controlled drugs for
pain;  the role of tolerance, addiction and dependence in the
consumption of these drugs; and implications of long-term use in
noncancer disease states.

o  Develop and refine biobehavioral techniques for optimizing
adherence to pain management.

Behavior-Related Interventions

o  Evaluate research strategies to integrate medical, nursing,
dental, neurological, pharmacological, and behavioral treatments for
pain problems.  Compare the relative effectiveness of each mode of
treatment, and combined treatments, and their potentiating effects on
multiple outcomes, such as pain, physical functioning, psychological
functioning, health care utilization, and costs.

o  Conduct research on the mechanisms and process variables that are
responsible for the efficacy of behavioral interventions.  This
research includes studies to understand better the effect of
patients' expectations and beliefs, psychophysiological states (e.g.,
anxiety, relaxation, stress), adherence, and specific cognitive
(e.g., imagery) and social (e.g., support) components in behavioral
interventions.

o  Determine which behavioral treatments are most effective for
specific subgroups of patients differentiated by factors such as age,
gender, race, ethnic group, level of dysfunction, or psychosocial
characteristics.

o  Conduct clinical trials of cognitive/behavioral pain control
methods and combinations of medical, pharmacological, and
cognitive/behavioral pain control methods.

o  Compare the costs of various types of interventions for pain,
including economic analyses of pain, pain dysfunction, and pain
treatments with different and combined biomedical and biopsychosocial
models of treatment.

o  Investigate the effectiveness and appropriate targeting of
alternative treatments (e.g., hypnosis, massage, spinal
manipulations, acupuncture) using randomized, controlled trials of
these treatments in association with conventional medical approaches.

o  Assess methods for primary, secondary, and tertiary prevention of
pain.

o  Establish dose-response curves for biobehavioral interventions.

o  Test interventions to improve health care practice in such areas
as pain assessment, analgesic management, pain prevention, and
rehabilitation.

Commonalities and Differences in Pain Expression, Experience, and
Treatment

o  Study cognitive factors in the experience of pain, disability, and
pain behaviors across disorders, including such factors as self-
efficacy, perceived control, and pain beliefs.

o  Establish the factors that prevent a person with acute pain from
developing a chronic pain problem and a chronic pain- related
disability.  Areas to assess include patient biological/organic,
psychosocial, and socioeconomic characteristics, interactions of the
patient with health care providers, family and social supports, and
workplace factors.

o  Refine existing techniques for measuring pain and develop new
techniques that are disease- and outcome-specific for different
populations.

o  Determine the supraspinal mechanisms of pain modulation, determine
the effects of specific pain treatments on these central nervous
system processes, and apply new findings on CNS plasticity to the
understanding of pain.

o  Examine the interrelationships between pain and other symptoms and
comorbidities (e.g., fatigue, sleep alterations, nausea, vomiting,
anxiety, mood disorders, physical deconditioning, stress).

Pain in Special Populations

o  Test culturally sensitive approaches to pain assessment and
management, including translation of the instruments into foreign
languages and validation as needed.

o  Investigate biobehavioral pain treatments for special populations
including infants, children, elderly, cognitively impaired, ethnic
minority groups, substance abusers with pain disorders, and
individuals with disabilities.

o  Determine effective biobehavioral interventions for HIV- and AIDS-
related pain, as well as the pain prevalence, scope, and severity of
patients who are HIV-infected.  Explore alterations in nociceptive
mechanisms and pain perception in patients with HIV.

o  Investigate the roles of sleep and circadian variation in the
precipitation and modulation of pain in populations who have special
rest - activity needs such as infants, children, elderly, pregnant
women, night-shift workers.  This research could include studies of
the effect of pain and its pharmacological treatment on sleep and
daytime alertness, as well as the effects of disturbed sleep on pain
and pain perception.  Studies of seasonal and other variations are
also appropriate.

o  Test and evaluate pharmacotherapies and behavioral treatments in
patients with current and past histories of addiction, including
infants born to drug-, alcohol-, and tobacco-dependent mothers, and
HIV-infected persons.

o  Investigate the effectiveness of biobehavioral pain management in
terminally ill and dying patients.

o  Study the interrelationship of Axis II, as well as Axis I,
psychiatric disorders (e.g., borderline personality, histrionic,
antisocial) and chronic pain, and relate these findings to
pharmacological and behavioral therapies. o  Determine gender-related
differences in the pain experience, such as whether the experience of
clinical chronic pain varies during the menstrual cycle and, if so,
the hormonal, immunological, neuronal, and psychological correlates
of this variability.

o  Investigate biobehavioral approaches to managing pain associated
with acute and chronic illness such as arthritis, cancer, diabetes,
sickle cell disease, low back pain, headaches, temporomandibular
disorders, and other orofacial pain conditions.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 20, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.

Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS
398 (rev. 9/91) and will be accepted at the standard application
deadlines as indicated in the application kit.  Application kits are
available at most institutional offices of sponsored research and may
be obtained from the Office of Grants Information, Division of
Research Grants, National Institutes of Health, Westwood Building,
Room 449, Bethesda, MD 20892, telephone 301/435-0714.  After May 8,
1995, the telephone number will be (301) 435-0715 and the address
will be as below.  The title and number of the program announcement
must be typed in Section 2a on the face page of the application.
Applications for the FIRST award (R29) must include at least three
sealed letters of reference attached to the face page of the original
application.  FIRST award (R29) applications submitted without the
required number reference letters will be considered incomplete and
will be returned without review.

The completed original application and five legible copies must be
sent or delivered to:

Division of Research Grants
National Institutes of Health
6701 Rockledge Drive, Room 1040 MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS
referral guidelines.  Applications will be reviewed for scientific
and technical merit, in accordance with the standard NIH peer review
procedures.  Following scientific-technical review, the applications
will receive a second-level review by the appropriate national
advisory council.

Applications that are complete and responsive to the program
announcement will be evaluated for scientific and technical merit by
an appropriate peer review group convened in accordance with the
standard NIH peer review procedures.  As part of the initial merit
review, all applications will receive a written critique and undergo
a process in which only those applications deemed to have the highest
scientific merit, generally the top half of applications under
review, will be discussed, assigned a priority score, and receive a
second level review by he appropriate national advisory council or
board.

Review Criteria

o  scientific, technical, or clinical significance and originality of
proposed research;

o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;

o  availability of the resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research;

o  adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.

The initial review group will also examine the provisions for the
protection of human and animal subjects and the safety of the
research environment.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications assigned to that institute/center (IC).  The following
will be considered in making funding decisions: quality of the
proposed project as determined by peer review, availability of funds,
and program priority.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Dr. Mary Lucas Leveck
National Institute of Nursing Research
Natcher Building, Room 3AN-12
Bethesda, MD  20892-6300
Telephone:  (301) 594-5963
Email:  mleveck@ep.ninr.nih.gov

Dr. Patricia Bryant
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AN-24K
Bethesda, MD  20892-6402
Telephone:  (301) 594-2095
Email:  BryantP@DE45.nidr.nih.gov

Dr. Andrew Monjan
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
Gateway Building, Suite 3C307
Bethesda, MD  20892
Telephone:  (301) 496-9350
Email:  monjana@gw.nia.nih.gov

Dr. Julia B. Freeman
Extramural Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building, Room 5AS-19F
Bethesda, MD  20892-6500
Telephone:  (301) 594-5052
Email:  freemanj@ep.niams.nih.gov

Dr. Claudette Varricchio
Community Oncology and Rehabilitation Branch
National Cancer Institute
Executive Plaza North, Suite 300
Bethesda, MD  20892
Telephone:  (301) 496-8541
Email:  varriccc@dcpcepn.nci.nih.gov

Dr. Louis Quatrano
National Center for Medical Rehabilitation Research
National Institute on Child Health and Human Development
Building 61E, Room 2A03
Bethesda, MD  20892-7510
Telephone:  (301) 402-2242
Email:  quatranl@hd01.nichd.nih.gov

Dr. Joseph Frascella
Behavioral Neurobiology Research Branch
National Institute on Drug Abuse
Parklawn Building, Room Number 10A-19
Rockville, MD  20857
Telephone:  (301) 443-4877
Email:  jf80t@nih.gov

Dr. Peter G. Kaufmann
Behavioral Medicine Research Group
National Heart, Lung, and Blood Institute
6701 Rockledge Drive MSC 7936
Bethesda, MD  20892-7936
Telephone:  (301) 435-0404
Email:  pvk@cu.nih.gov

Dr. Fred Altman
Basic Prevention and Behavioral Medicine Research Branch
National Institute of Mental Health
Parklawn Building, Room Number 10-104
Bethesda, MD  20892
Telephone:  (301) 443-4337
Fax: (301) 443-4045
Email:  hfb@cu.nih.gov

Dr. Cheryl A. Kitt
Division of Demyelinating, Atrophic and Dementing Disorders
National Institute of Neurological Disorders and Stroke
Federal Building, Room 802
Bethesda, MD  20892
Telephone:  (301) 496-1431
Email:  kittc%nindsfed%nih@fedtcp.ninds.nih.gov

Dr. John Spencer
Office of Alternative Medicine
Executive Plaza South, Suite 450
Bethesda, MD 20892-9904
Telephone: (301) 402-4333
Email: spencerj@odeps.nih.gov

Direct inquiries regarding fiscal matters to:

Sally A. Nichols
Grants Management Officer
National Institute of Nursing Research
Natcher Building, Room 3AN-32
Bethesda, MD  20892-6301
Telephone:  (301) 594-6869
Email:  snichols@ep.ninr.nih.gov

Theresa Ringler
Division of Extramural Research
National Institute of Dental Research
Natcher Building, Room 4AS-55
Bethesda, MD  20892-6402
Telephone:  (301) 594-4800
Email:  Rubenstein@DE45.nidr.nih.gov

Joanne Colbert
Grants Management Office
National Institute on Aging
Gateway Building, Suite 2N212
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
Email:  colbertj@gw.nia.nih.gov

Mary Graham
Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building, Room 5AS.19A
Bethesda, MD  20892-6500
Telephone:  (301) 594-3504
Email:  grahamm@ep.niams.nih.gov

Bob Hawkins
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Suite 243
Bethesda, MD  20892
Telephone:  (301) 496-7800
Email:  Hawkinsr@gab.nci.nih.gov

Mary Ellen Colvin
Grants Management Specialist
National Institute of Child Health and Human Development
Building 61, Room 8A17G
Bethesda, MD  20892-7510
Telephone:  (301) 496-1303
Email:  colvinm@hd01.nichd.nih.gov

Gary Fleming
Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 8A-54
Rockville, MD  20857
Telephone:  (301) 443-6710
Email:  gfleming@aoada.ssw.dhhs.gov

Jane Davis
Grants Management Officer
National Heart, Lung, and Blood Institute
Rockledge Two, Room 7174
Bethesda, MD  20892-7926
Telephone:  (301) 435-0166
Email:  janedavis:nhlbi-wb-1:nih

Diana Trunnell
Grants Management Officer
National Institute of Mental Health
Parklawn Building, Room 7C08
Bethesda, MD  20892
Telephone:  (301) 443-3065
Email:  dt21a@nih.gov

Karen D. Shields
Grants Management Branch
National Institute of Neurological Disorders and Stroke
Federal Building, Room 1004
Bethesda, MD  20892
Telephone:  (301) 496-9231
Email:  Karen_Shields%NINDSFED%NIH@fedtcp.ninds.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.361.  Awards are made under authorization of the
Public Health Service Act, Title IV, Part A (Public Law 78-410, as
amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 52 and 45
CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
review.

The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routing education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the phs
mission to protect and advance the physical and mental health of the
american people.

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