REHABILITATIVE INTERVENTION SUPPLEMENTARY SUPPORT

NIH GUIDE, Volume 26, Number 39, December 5, 1997

RFA:  MH-98-003

P.T.

National Institute of Mental Health

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

PURPOSE

The National Institute of Mental Health (NIMH) announces the availability of
competitive supplementary support for existing clinical therapeutic research
grants.  The purpose of the supplementary support is to study strategies for
rehabilitative interventions that improve residual mental and functional
impairments that remain following active treatment for mental disorders.  The
strategies are to be aimed at the long-term sequelae of mental disorders in
patients currently in treatment.  The focus is on the transition from active
treatment (acute, continuation, or maintenance) to longer-term clinical
management and rehabilitation.  Research supplements are encouraged on the
efficacy and effectiveness of pharmacologic, non- pharmacologic, and combined
rehabilitative strategies.

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 Request for Applications (RFA),
Rehabilitation Intervention Supplement is related to the priority areas of
chronic disabling conditions. 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).

ELIGIBILITY REQUIREMENTS

Applications for supplementary support may be submitted by Principal
Investigators of National Institute of Mental Health (NIMH) grants focused on the
treatment or rehabilitation of mental disorders.  Applications may be submitted
by domestic and foreign, 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.  To be
eligible for consideration for this competitive supplement, current treatment
grants must be active and funded at the time of award, with a minimum of 12
months remaining from September 30,1998.  Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as Principal
Investigators.

MECHANISM OF SUPPORT

This RFA will use competitive supplements to the following NIH research project
grant mechanisms: R01, R10, R21, R37, P30.  (Foreign institutions are not
eligible to apply for a P30 supplement.)  Questions about these grant mechanisms
may be directed to program staff listed under INQUIRIES.

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 anticipated award date is September 30, 1998.  The total project period for
an application submitted in response to this RFA may not exceed the tenure
remaining on the parent grant to be supplemented.

FUNDS AVAILABLE

It is anticipated that at least $750,000 in direct costs will be made available. 
Direct costs for the first year of supplemental funding under this RFA may not
exceed that of the current year of the parent grant, up to a maximum of $100,000. 
Funding for subsequent years is dependent on demonstrated progress in meeting the
goals of the project and on the continued availability of funds.

TERMS AND CONDITIONS OF SUPPORT

Supplemental funds may be used for expenses clearly related and necessary to
conduct the proposed supplemental research, including both direct and allowable
indirect costs. Supplemental funds may not be used to conduct research that is
an integral part of the parent grant, and may not be used to operate a treatment,
rehabilitation, or other service program.

RESEARCH OBJECTIVES

Background

Basic and clinical research have led to the development of psychiatric
interventions that are efficacious for many mental disorders.  Despite these
advances, the current armamentarium of pharmacologic, somatic, and
psychotherapeutic treatments do not always lead to full remission of symptoms or
to complete remission of cognitive and emotional impairment in individuals with
mental disorders.  Social and family functioning may also remain impaired.  A
broad array of basic brain deficits, including neurocognitive (e.g., memory,
language, executive function), neuromotor (e.g., motor retardation, visuo-motor
functioning), perceptual (e.g.,visuo-spatial, sensory integration, body image)
and homeostatic (circadian rhythms, glucose regulation), may be residual and
contribute to some level of functional impairment across many areas, including
every-day problem solving and social interaction.

Rehabilitation programs and rehabilitation research for patients with mental
disorders have traditionally focused on global psychosocial skills development
such as learning appropriate social interactions, vocational training, community
living skills, symptom management, cognitive training and problem solving.  For
many patients and their families these approaches have led to marked improvements
in function and quality of life.  However, patients who do not experience
improvement have high program drop out rates. This group of patients tends to
include the most severely disabled or those whose particular pattern of brain
deficit limits their participation in or ability to take advantage of these
therapies.  For example, in patients with schizophrenia, neuro-cognitive deficits
have been reported to contribute to functional impairment independent of the
positive and negative symptoms of psychopathology and appear to limit the rate
at which traditional rehabilitation strategies succeed.

There is little research on the efficacy of rehabilitative strategies with
certain groups of patients including the elderly or individuals having comorbid
psychiatric and physical illnesses.  In addition, rehabilitative interventions
have not always been examined in successfully treated patients, who achieve full
remission of their primary psychopathology but continue to experience some
functional impairment as the result of the illness or the treatment.

This RFA is an effort to focus rehabilitation research more closely on the brain
(e.g. brain-related functional deficits).  For the purpose of this announcement,
rehabilitative interventions are considered to be any one or any combination of
the following modalities: pharmacological, somatic, psychotherapeutic and non-
traditional provided that it has the potential to enhance the functioning of the
brain beyond the normal course of treatment, to facilitate cognitive or emotional
plasticity, or to provide the basic functional capacity necessary to succeed in
more traditional rehabilitation programs.  This includes rehabilitation
strategies which were initially developed for brain impairment resulting from
known organic, traumatic, or developmental causes.

The aim of this solicitation is to extend ongoing treatment research to
consideration of rehabilitative interventions for adults and aged individuals
with mental disorders.

Research Issues

In the absence of an adequately well-researched data base, those studies that
will advance the field by addressing the following or similar outstanding
questions are encouraged:

What is the optimal relationship and sequencing of different rehabilitative
modalities directed at residual impairments? How is this affected by the
patterns, nature and severity of deficits?

Under what conditions are pharmacological rehabilitation strategies appropriate? 
In particular, the use of neurocognitive enhancing therapeutics?

What is the appropriate timing for rehabilitative interventions?  At what point
in the treatment process should rehabilitation be initiated?  What factors
contribute to patients? willingness to participate and remain in rehabilitation?

In the presence of comorbid mental or physical disorders are residual impairments
altered or compounded in ways that have implications for rehabilitation?

Do aging processes, comorbidity and diagnosis interact to predict functional
rehabilitation or length of time to improvement?

Can profiles of neurocognitive deficits be developed or further refined that can
facilitate identifying patients needing basic rehabilitation prior to, or instead
of, more traditional modalities?

What is the role of rehabilitation as an adjunct to nonpharmacological somatic
treatments, such as electroconvulsive therapy (ECT), bright light treatment,
sleep deprivation, or repetitive Transcranial magnetic stimulation (rTMS)?

In addition, general issues confronting all treatment and rehabilitation research
are relevant for consideration in responses to the present announcement. These
include:

Evaluation of variations, in efficacy or effectiveness of rehabilitation
strategies across comorbid groups, ethnic, racial, or age groups or gender.

Need for development and utilization of valid and reliable outcome measures for
rehabilitation that can be used sequentially as patients attain different
hierarchical levels of functioning.

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
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.

LETTER OF INTENT

Prospective applicants are asked to submit by February 2, 1998 a letter of intent
that includes a descriptive title of the proposed research for which a supplement
is to be requested, if different from the parent grant; the name, mailing and
email address, and telephone/FAX numbers of the Principal Investigator,
identities of other key personnel and participating institutions, and the number
and title of this RFA; and the title, number, and source of the existing PHS
treatment research grant for which supplementary funding is sought.  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 review.

The letter of intent is to be sent to:

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

APPLICATION PROCEDURES

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 and from the Division 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;
Email:ASKNIH@OD.NIH.GOV.

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.  In addition, the RFA title and
number, Rehabilitative Intervention Supplementary support MH-98-003, must be
typed in section 2 of the face page of the application form and the YES box must
be marked.

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)
NATIONAL INSTITUTES OF HEALTH
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
to:

Mary Lou Prince
Adult and Aging Treatment and Preventive Interventions Research Branch
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.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the NIH Center
for Scientific Review (CSR) and for responsiveness by NIMH staff.  The CSR will
not accept applications that do not meet eligibility requirement previously
stated (grant does not have at least 12 months remaining at time of anticipated
award September 30, 1998. Incomplete and/or non-responsive applications will be
returned to the applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group 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 National
Mental Health Advisory Council.

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
field?

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 application.

o  Availability of special opportunities for furthering research programs through
the use of unusual talent resources, populations, or environmental conditions in
other countries that are not readily available in the United States, or that
provide augmentation of existing U.S. resources (for foreign applications only).

AWARD CRITERIA

Competitive supplements under this RFA will be awarded based on scientific merit
as determined by peer review, availability of funds, and programmatic priorities.

INQUIRIES

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:

Enid Light, Ph.D.
Adult and Geriatric Treatment and Preventive Interventions Research Branch
National Institute of Mental Health
5600 Fishers Lane, Room 10-75
Rockville, MD  20857
Telephone:  (301) 443-1185
FAX:  (301) 594-6784
Email:  elight@nih.gov

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
Email:  Diana_Trunnell@nih.gov

AUTHORITY AND REGULATIONS

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).

The 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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