NIH Guide, Volume 26, Number 38, November 21, 1997

RFA:  MH-98-002


National Institute of Mental Health

Letter of Intent Receipt Date:  February 2, 1998
Application Receipt Date:  March 11, 1998


The National Institute of Mental Health (NIMH) invites research grant
applications to test models of depression recognition and treatment to prevent
and reduce suicidal behavior in older patients in primary care settings.  The
purpose of this RFA is to encourage implementation of research studies with
sufficient sample size and heterogeneity to be generalizable to various primary
care settings.  Research grant funds may not be used to operate a treatment,
rehabilitation or other service program.  Applications should represent
innovations and improvements in treatments, rather than requesting support for
existing or usual patient care costs.  Suicidal behavior is broadly defined to
include ideation and attempts, as well as completion. The results are expected
to lead to treatment recommendations for primary care.


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 RFA, Prevention of Suicidal Behavior
in Older Primary Care Patients, is related to the priority area of reduction in
suicides by way of primary care recognition and treatment of mental disorders. 
Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: 
Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through
the Superintendent of Documents, Government Printing Office, Washington, DC
20402-9325 (telephone 202-512-1800).


Applications may be submitted by 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. Foreign institutions are not eligible for these awards. 
Racial/ethnic minority individuals, women, and persons with disabilities are
encouraged to apply as Principal Investigators.


This RFA will use the Investigator-Initiated Interactive Research Project Grant
(R01), which is described in PA-96-001, NIH Guide, Vol. 24, No. 35, October 6,
1995. The Investigator-Initiated Interactive Research Project Grant (IRPG) group
must include a minimum of two independent applications.  Applications for both
new (Type 1) and competing renewal (Type 2) awards may be submitted as part of
an IRPG group.

Responsibility for the planning, direction, coordination and execution of the
proposed projects will be solely that of the applicants.  It is expected that
each application include a minimum of two study sites.  The total project period
for an application submitted in response to this RFA may not exceed five years.

This RFA is one-time solicitation.  Future unsolicited competing continuation
applications will compete with all investigator-initiated applications and be
reviewed according to the customary peer review procedures.


The estimated total costs available for the first year of support for this
program is $2 million.



The importance of recognizing and treating late life suicidal behavior and
depression within the primary care context stems from the findings that late life
suicide victims typically have contacted their primary care physician prior to
their death. The majority of older suicide victims have had late onset
depressions, and these depressions are not typically detected or treated by the
primary care physician.  This evidence, along with an uncontrolled Swedish study
indicating that treatment of depression by primary care physicians led to lower
suicide rates, has resulted in recommendations that late life suicide prevention
efforts be focused on more adequate recognition and treatment of depression in
primary care.

Recognition of late life depression and suicidal behavior by primary care
providers can be enhanced by several methods. These include, but are not limited
to, training primary care providers to be more knowledgeable about depression and
its relevant affective, cognitive, and somatic symptoms, as well as employing
screening measures with proven sensitivity and specificity.

Rates of major depression in older primary care patients range from 5 to 10%,
while rates of minor depression have been estimated to range from 20 to 30%. 
Although suicide attempts and completions are relatively rare events, rates of
suicidal ideation among older patients in primary care range from 5% among
unselected groups, about 9% among older males, and up to 40% in depressed male

There are gender differences in rates of late life depression and suicidal
behavior.  Older women are more likely to admit to depressive symptoms, and  are
more likely to make non-lethal suicide attempts than older men.  Older males are
less likely to report depressive symptoms, but are more likely to complete

In addition to reducing the risk of suicidal behavior, adequate recognition and
treatment of late life depression can also prevent non-suicide mortality, and
reduce unnecessary suffering in patients and their family members.  Moreover,
appropriate diagnosis and treatment can reduce medical morbidity, functional
impairment, and excess medical costs.

Research Objectives

There are at least two models of treatment of late life depression and suicidal
behavior in primary care that have been tested in single site studies.  One model
involves improving the abilities of the primary care physician to detect and
treat depression without additional services of mental health professionals,
using either or both pharmacologic and psychosocial or problem-solving
approaches.  A second general model has used a collaboration between primary care
physicians and mental health professionals, where expertise in psychopharmacology
in treating depression is provided by a psychiatrist, and psychosocial
interventions are provided by trained mental health professionals (e.g., social
workers, psychologists, nurse practitioners).

With regard to treatment approaches, pharmacologic advances have indicated that
the newer serotonin reuptake inhibitors (SSRIs) may be as efficacious in older
adults as the proven tricylics (e.g., nortriptyline).  SSRIs are of particular
interest for the present research objectives for two reasons:  A possibly higher
treatment compliance due to a lower side effect profile, and a specific effect
for decreasing suicidal ideation early in treatment in younger adults.  Hormone
replacement therapy as an ongoing medication for female patients, or as an
adjunct treatment for depression, may be considered when designing test of
pharmacologic treatment effects.  With regard to psychosocial treatments,
standardized (i.e., manualized) approaches must be considered and can include
cognitive- behavioral, problem-solving, and interpersonal therapy approaches
which have all been proven efficacious with older adults.

These treatment models, as well as other approaches, deserve further
consideration with regard to short- and long-term efficacy.  The applicability
of these approaches to primary care sites and their affordability need to be
assessed. Investigators are encouraged to consider the acceptability of treatment
approaches, including side effect profiles of pharmacologic approaches, and older
patients? preferences for psychosocial treatments.

The primary patient outcome measures of interest include, but are not limited to:
suicidal behavior, including ideation (passive, active), attempts, intent, and
self- destructive behavior.  Secondary patient outcomes of interest include
depression (minor, major), anxiety, cognitive impairment, substance use, sleep
problems, hopelessness, and personality traits.  Additional outcomes of interest
include mortality, functional status, medical burden (including pain), service
use (e.g., medication use, emergency room visits, visits not related to
depression), and satisfaction with care.

Provider variables of interest include, but are not limited to: knowledge of and
skills for diagnosing and treating late life suicidal behavior and depression,
time spent with patient, and specialty (e.g., internist, family practitioner,
nurse practitioner, geriatrician).

Although suicidal behavior can be a transient phenomenon, late life depression
is frequently a chronic condition. Treatment designs should consider how to
define both acute and maintenance phases, rationales for selection of
pharmacologic and psychosocial treatments (including acceptability and side
effect profiles), and protocols for suicidal behavior.  Treatment studies
typically have significant attrition rates, and methodological approaches to
tracking and statistically modeling non-deceased attritors (e.g. effects of
partial treatments) should be considered.

Primary care treatment settings can include those in academic environments. 
However, the generalizability of study findings would be enhanced by their
combination with more typical primary care sites, such as nonacademic outpatient
clinic sites, including those under managed care health plans.


Applicants are required to include in their budgets travel costs for 3
investigators from each site to travel to Bethesda, MD, for 2 annual meetings,
in addition to other scientific meetings that are justified.


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).

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 28, 1994
(FR 59 14508-14513) and 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.


Prospective applicants are asked to submit, by February 2, 1998, a letter of
intent that includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, the identities of
other key personnel and participating institutions, and the number and title of
the RFA in response to which the application may be submitted.  Although a letter
of intent is not required, is not binding, and does not enter into the review of
a subsequent application, the information that it contains allows NIMH staff to
estimate the potential review workload and avoid conflict of interest in the

The letter of intent is to be sent to:

Jane L. Pearson, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
Parklawn Building, Room 10-75
Rockville, MD  20857
Telephone:  (301) 443-3598
FAX:  (301) 443-4045


The research grant application form PHS 398 (rev. 5/95) is to be used in applying
for these grants.  These forms are available at most institutional offices of
sponsored research or from the Office of Extramural Outreach and Information
Resources, National Institutes of Health,  6701 Rockledge Drive,  MSC 7910,
Bethesda, MD 20892-7910; telephone (301) 710-0267; fax (301) 480-0525; E-mail:

Each application must have its own descriptive title and a principal
investigator.  The contributions of all shared resources must be summarized in
item (I) CONSULTANTS of the Research Plan, describing the collaborative
interactions of the IRPG group.  However, the detailed description and budget for
each shared resource may be requested by only one application in each IRPG group,
in the project most suited to oversee that resource activity.  Item (I) must be
complete, with enough detail for NIH staff and reviewers to understand the full
scope of interactive collaborations within the IRPG group.  Other component
projects must NOT be included as appendix material.

Shared Resources --- A description of the shared resources that will be supported
with a research project must be inserted separately in the application, after
item (I) of the Research Plan.  This must include an explicit description of the
methods and procedures to be used, the services, tests, animals, or facilities
to be provided, and a description of the involvement and protection of human
subjects or vertebrate animals, if appropriate.  Extensive shared resources or
those with large budgets may be more appropriate as "cores" in program projects. 
Applicants are urged to contact an NIH staff member to discuss the nature and
extent of proposed shared resources in an IRPG group.

The detailed description and budget request for a shared resource must be
included in the application of the principal investigator who will serve as the
leader of that resource.  If the proposed shared resource will be managed by an
individual who is not the principal investigator of any of the components of the
IRPG group, the shared resource component should be included in one of the IRPG
applications according to the following instructions.  Support for a shared
resource must not be requested by a separate application.

o  If the shared resource will be managed by a member of the research team of a
component IRPG, the budget for the shared resource must be presented in that

o  If the shared resource will be managed by someone (but not the principal
investigator) employed by an applicant institution, the budget for the shared
resource component must be presented in the component IRPG application from that
institution.  If there is more than one component IRPG application from that
institution, the request for support of the shared resource must be included in
the application of the principal investigator who will use that resource the

o  If the shared resource is not located within an applicant institution, it may
be supported by a contract from a component IRPG awardee.  As above, support of
the shared resource must be requested in the application of the principal
investigator who will use the facility or resource the most.

o  If all projects will share a remote resource equally, or if the request is to
provide only fee-for-service testing or procedures, the costs may be included
within each research project.  Staff in the appropriate NIH institute or center
should be contacted for further guidance in preparing these requests.

Instructions for Preparing Applications on the PHS 398 (rev. 5/95)

The following instructions address ONLY the parts of the PHS 398 research grant
application form for which information about the proposed interactive research
is requested.  All other parts of the grant application should be prepared
according to the instructions in the PHS 398 booklet (rev. 5/95).

Cover Letter:  A cover letter that identifies the total number of applications
in the IRPG group and the principal investigator for each must be enclosed in the
package of applications.


Item 2. Mark "Yes" and enter the RFA number and title, ?Prevention of Suicidal
Behavior in Older Primary Care Patients.?

Items 7-8. Enter the direct costs and total costs - includes the costs of the
specific research project AND the costs of all "shared resources" to be supported
through THIS application (see below for details concerning budget presentation).

Form BB:

Description.  Provide a brief description (abstract) of the research proposed
according to the instructions provided on page 10 of booklet for the PHS 398
(rev. 5/95).  The description of the proposed IRPG interactions and/or any shared
resources requested through this application may be included.

Performance Site(s).  The performance site(s) of THIS project AND of any shared
resource(s) in the IRPG group that will be used in this project (any involved
institution should be named only once).

 Key Personnel.  List first the principal investigator and key personnel engaged
on THIS project, followed by all key personnel engaged on any shared resource(s)
to be supported by this project.  Then list, as collaborators, all principal
investigators and professional personnel engaged in all component projects and
shared resources in the IRPG group.

Form CC:

TABLE OF CONTENTS.  Add the page locations for Part 2 IRPG Interactions of item
(I) of the Research Plan and for each of the shared resources proposed to be
supported through this application.

Forms DD and EE:

Project Budget.  Complete these pages as directed with the budget requests for
this research project only.  Do not include any shared resources here, since they
will have separate budget pages.  Provide clear justification for all items
requested in the first year and for any significant increases or decreases in any
category in future years.

Shared Resource Budgets(s).  Complete a separate form DD and form EE for each
shared resource facility or activity that will be supported through THIS project,
do not include budgets for shared resources that will be supported through other
projects in the IRPG group.  CLEARLY LABEL these form pages as "shared resource
budgets" by typing the name of the shared resource in the upper left portion of
the page.

Composite Budget.  If any shared resources are requested as part of this
application, form DD should be used to prepare a composite budget showing the
requested total direct costs for the project and the shared resource(s).  The
dollar totals listed must match the amounts entered on Item 7 on the application
face page (form AA).  This composite budget will help reviewers and staff
reconcile the figures on the face page with those in the body of the application.

Form FF:

The biographical sketch for each key investigator involved in the project AND any
shared resource(s) to be supported by this project must be included.

Form GG:

Other support information for all professional staff involved in the project AND
any shared resource(s) to be supported by this project must be included.

Form HH:

Besides completing form HH for the project, a separate form HH for each shared
resource to be supported by the project, itemizing the facilities and major
equipment that will be available to the IRPG group, must be completed.


The instructions in section C-9 (pages 15-19) of the PHS 398 must be followed to
complete a. through d. (Page 16) of the Research Plan in detail.  Attention may
be given to the integration of the individual project into the overall IRPG group
effort.  The overall research plan (a.-d.) for the project may not exceed 25
pages.  The following points may be addressed in the appropriate sections.

a.  SPECIFIC AIMS.  Besides listing the specific objectives of the individual
research project for the total period of requested support, briefly summarize how
the overall objective or long-term goal of the research relates to the goals of
the IRPG group.

b.  BACKGROUND AND SIGNIFICANCE.  Besides discussing the overall scientific
significance of the proposed research, this section may briefly summarize the
relevance of the project to the scientific goals of the IRPG group.

(I) CONSULTANTS.  Particular attention must be given in completing this section
of the Research Plan.  It must have subsections as follows:  Part 1 of (I) must
address the collaborations that are unique to the research proposed in the
application as an independent project.  Part 2 must describe in detail the
proposed interactions and collaborations within the IRPG group, and MUST BE

on page 24 of the PHS 398 Instructions should be consulted for help in
determining what information to provide about consultants and collaborators who
are proposed for the individual research project.

PART 2.  IRPG INTERACTIONS.  The collaborative efforts among components of the
IRPG group must be described in this section.  The description should be concise,
although the number of pages is not restricted.  However, this section must not
be used to avoid the page limitations of the Research Plan in Sections a.-d. 
Each component application of the IRPG group must contain IDENTICAL GROUP
STATEMENTS describing the collaborative efforts and the use of any requested
shared resources.  Preparing this section should be a joint effort among the
participating principal investigators under the leadership of the Program
Coordinator, who is responsible for coordinating the collaborative efforts among
all of the IRPG principal investigators.

The following three items must be included in Part 2 IRPG INTERACTIONS:

that is part of the IRPG group, giving each an IRPG project number, and showing
the type of application Project Title, and principal investigator must be
provided.  The Program Coordinator should also be identified here.  The Program
Coordinator must be the first investigator named on the list, with the title
"Program Coordinator" following his/her name.  For example:

IRPG one, R01, (project title), Jessica W. Smith, (Program Coordinator) IRPG two,
R01, (project title), (PI) IRPG three, R01, (project title), (PI)

an opportunity for the IRPG group to give conceptual wholeness to the overall
program.  It must include discussion of the intended interactions among the IRPG
component projects and describe how each shared resource will contribute to those

The general IRPG group objectives and the strategy for achieving those objectives
must be described.  As the strategy develops, each project and shared resource
should be cited for its role in the overall scheme.  Include a brief overview of
the goals, objectives, rationale, and key methods and approaches for the research
proposed in each project and shared resource.  Describe how each relates to the
scientific goals of the IRPG group and/or the anticipated approach to achieve the
IRPG group goals.  A diagram of the interrelationships of the projects and the
enhancement of the collaborative efforts of the research projects by each shared
resource may be helpful.

3.  SUMMARY OF SHARED RESOURCES.  If any shared resources are requested by the
IRPG group, identical information about their use must be included in all
applications of the IRPG group to aid in review of the application.  The
application should specify the anticipated percent of use of each shared resource
in the entire IRPG group by each project in the IRPG group.  This information
will provide reviewers, advisory council members, and NIH staff with a complete
picture of the overall shared resource contribution to the IRPG group.

section must be added to the Research Plan, after (I) Consultants, for each
shared resource to be supported by this application.  The first page of this
section should clearly show the descriptive title of the shared resource; the
name, title and affiliation of the individual who will manage the shared
resource; and the specific location (department, institution, city) of the shared

A concise, but explicit and complete, description and justification for the
shared resource requested.  This section must present a clear picture of the
approaches, methods, techniques, animals, and/or special populations that will
be used to support each project in the IRPG group.  Specifically address how the
available resources and environment will be sufficient to address the needs of
all of the projects in the IRPG group.  If appropriate, address the involvement
and protection of human subjects and/or vertebrate animals if that has not been
addressed under (e) and (f) of the Research Plan of the project.

For each component of an IRPG group, a signed, typewritten original application,
five exact single-sided copies, and five sets of appendix material must be
submitted.  Each application must be complete, with all approvals, budgets, and
signatures from the appropriate officials of the applicant institution.

All of the applications constituting the proposed IRPG group must be submitted
in a single package, whether or not the applications are from the same
institution.  A cover letter must list the total number of applications submitted
for the IRPG group, clearly identifying each application and the principal
investigator of each.  For each component application in the IRPG group, the
original, five copies, and the appendix material must be bundled together and
clearly identified.  Failure to follow the instructions regarding application
receipt dates and packaging may lead to a delay in review.

The RFA label available in the PHS 398 (rev. 5/95) application form must be
affixed to the bottom of the face page of the application.  Failure to use this
label could result in delayed processing of the application such that it may not
reach the review committee in time for review.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed, photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW (formerly Division of Research Grants)
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application must be sent

Jane L. Pearson, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
5600 Fishers Lane, Room 10-75
Rockville, MD  20857

Applications must be received by March 11, 1998.  If an application is received
after that date, it will be returned to the applicant without review.  The Center
for Scientific Review (CSR) will not accept any application in response to this
RFA that is essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application.  The CSR will not accept any
application that is essentially the same as one already reviewed.  This does not
preclude the submission of substantial revisions of applications already
reviewed, but such applications must include an introduction addressing the
previous critique.


Upon receipt, applications will be reviewed for completeness by the Center for
Scientific Review (CSR) and for responsiveness by NIMH staff.  Incomplete and/or
non-responsive applications will be returned to the applicant without further
consideration.  Applications that are complete and responsive to the Request for
Applications will be evaluated for scientific and technical merit by an
appropriate peer review group convened in accordance with the review criteria
stated below.  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 will be discussed, assigned a priority
score, and receive a second level review by the appropriate national advisory
council or board, when applicable.

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  In their
written comments reviewers will be asked to discuss the following aspects of the
application in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals.  Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application.

o  Significance:  Does this study address an important problem? If the aims of
the application are achieved, how will scientific knowledge be advanced?  What
will be the effect of these studies on the concepts or methods that drive this

o  Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider
alternative tactics?

o Innovation:  Does the project employ novel concepts, approaches or method?  Are
the aims original and innovative? Does the project challenge existing paradigms
or develop new methodologies or technologies?

o Investigator:  Is the investigator appropriately trained and well suited to
carry out this work?  Is the work proposed appropriate to the experience level
of the principal investigator and other researchers (if any)?

o Environment:  Does the scientific environment in which the work will be done
contribute to the probability of success?  Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements?  Is there evidence of institutional support?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

o The reasonableness of the proposed budget and duration in relation to the
proposed research.

o The adequacy of plans to include both genders, 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.

o The adequacy of the proposed protection for humans, animals or the environment,
to the extent they may be adversely affected by the project proposed in the


In the decision to fund applications, the following will be considered: The 
scientific and technical merit reflected in the priority score, the balance among
treatment approaches, and balance among geographic areas.


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

Direct inquiries regarding programmatic issues to:

Jane L. Pearson, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
5600 Fishers Lane, Room 10-75
Rockville, MD  20857
Telephone:  (301) 443-3598
FAX:  (301) 443-4045

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
5600 Fishers Lane, Room 7C-08
Rockville, MD  20857
Telephone:  (301) 443-2805
FAX:  (301) 443-6885


This program is described in the Catalog of Federal Domestic Assistance No.
93.242.  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.
Awards will be administered under PHS grants policy as stated in the Public
Health Service Grants Policy Statement (April 1, 1994).

PHS strongly encourages all grant and contract recipients to provide a smoke-free
workplace and promote the nonuse 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
routine 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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