RESEARCH ON ADHERENCE TO INTERVENTIONS FOR MENTAL DISORDERS

Release Date:  December 1, 1999 (see replacement PA-03-111)

PA NUMBER:  PA-00-016

National Institute of Mental Health

THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  THIS PA INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA.

PURPOSE

Maximal benefits from treatment or preventative interventions will not be 
achieved if individuals discontinue those interventions before completion.  Even 
if a protocol is completed, less than full adherence to one or more of its 
components can also limit the benefits.  For example, according to World Health 
Organization estimates, unipolar major depression will become the second leading 
cause of disability worldwide by the year 2020.  Although effective treatments 
exist, large segments of those who suffer from depression do not receive 
treatment.  Among those who do receive treatment with available antidepressant 
medications, estimates the Agency for Health Care Policy Research, forty percent 
do not complete the recommended 7-12 months regimen.  Thus, the full benefit of 
antidepressant medication therapy is not realized.  Similarly, substantial 
dropout rates from psychosocial and behavioral interventions  for mental 
disorders limit their public health impact.  In addition to unipolar major 
depression, bipolar disorder, schizophrenia, and anxiety disorders such as 
obsessive-compulsive disorders are among the leading causes of disability 
worldwide.  Available interventions for these disorders could have greater 
impact and relieve more suffering if adherence to them were improved.

This program announcement is intended to expand research on adherence and 
behavior change that integrates findings from the basic behavioral sciences with 
interventions for mental disorders, symptoms, or related disability.  Included 
are studies of mechanisms and processes that enhance or interfere with adherence 
to preventive, treatment, and rehabilitative interventions.  The interventions 
may be pharmacological, behavioral, or psychosocial.  Emphasis is on the 
development of innovative approaches to adherence and behavior change, 
especially models of interventions to improve adherence.  A well-articulated, 
empirically-based conceptual framework is therefore essential in applications 
solicited under this announcement.  Priority will be given to applications that 
also include a detailed plan for initial tests of that conceptual model.

Although the definition of "adherence" and "behavior change" will vary depending 
upon the nature and scope of the particular problems under study, clear 
definitions and psychometrically sound measures for these terms will be 
essential.  Definitions of "adherence" or "behavior change" might address, for 
example, the completeness and frequency with which a client engages in 
behavioral or psychosocial components of an intervention protocol, or the extent 
to which a client takes medications at the dosage and frequency prescribed.  
Other definitions and measures could focus on provider behaviors and 
intervention strategies.

Increased understanding of the mechanisms and processes underlying individuals' 
decisions to adhere or not to adhere to interventions for mental disorders, 
their symptoms, and related disability, would enhance our ability to develop 
models of interventions to modify those mechanisms and processes to increase 
adherence.  Although many theoretical models have been developed to describe the 
processes of adherence and behavior change, their potential has not been fully 
exploited to guide the design of pharmacological, behavioral and psychosocial 
interventions.  Progress in applied public mental health could be accelerated 
significantly by building on fundamental research in the behavioral and 
biomedical sciences related to motivation, persuasion, attitude change, 
decision-making, perception, self-efficacy, social cognition and other 
interpersonal processes, personality, family and community support, and the 
character of alliances between providers and clients.  Therefore, investigation 
of the utility of such theoretical models remains an important challenge.

Applications examining mechanisms and processes underlying provider strategies 
and behaviors that enhance recruitment, retention, and adherence are also 
encouraged.  Other areas of interest under this program announcement include 
research on approaches to decreasing stigma related to mental disorders and 
increasing adherence to interventions; studies of ways in which various informed 
consent procedures and other issues related to research ethics can facilitate or 
hinder adherence to interventions; and the development of reliable and valid 
measures for all the above areas.

The importance of adherence to the outcome of preventive, treatment, and 
rehabilitative interventions is well recognized, but it has often been treated 
simply as a nuisance variable in research.  Adherence must be regarded as a 
central focus in all research to develop models of interventions for mental 
disorders, symptoms, and related disability.

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 Program Announcement, Research on 
Adherence to Interventions for Mental Disorders, is related to the priority area 
of Mental Health and Mental Disorders.  Potential applicants may obtain a copy 
of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000/

ELIGIBILITY REQUIREMENTS

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.  Foreign institutions are not eligible for the Small Grant 
(R03) mechanism.  Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as principal investigators.

MECHANISM OF SUPPORT

This PA will use the following research grant mechanisms:  Small Grants (R03), 
Exploratory/Developmental Grants (R21), and Research Project Grants (R01).  The 
Small Grant (R03) provides two years of funding with a maximum of $50,000 direct 
costs for each year.  The  Exploratory/Developmental Grant (R21) provides three 
years of funding with an average of $125,000 direct costs for each year; it is 
intended for pilot testing of interventions and other aspects of intervention 
development.  The Research Project Grant (R01) provides up to five years of 
funding that is commensurate with the science proposed.

For all competing R03, R21 and R01 applications requesting up to $250,000 direct 
costs per year, specific application instructions have been modified to reflect 
"MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being undertaken at NIH.  
More detailed information about modular grant applications, including a sample 
budget narrative justification pages and a sample biographical sketch, is 
available via the Internet at: 
https://grants.nih.gov/grants/funding/modular/modular.htm.  Applications that 
request more than $250,000 in any year must use the standard PHS 398 (rev. 4/98) 
application instructions.

Because the small grants have special eligibility requirements, application 
formats, and review criteria, applicants are strongly encouraged to consult with 
program staff (listed under INQUIRIES) and to obtain the appropriate additional 
announcements for those grant mechanisms.  This is found at: 
https://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html 

RESEARCH OBJECTIVES

The need for research is urgent across a range of topics germane to adherence to 
interventions for mental disorders, symptoms, and related disability.  This 
program announcement will encourage grant applications for research in a number 
of critical areas, including, but not limited to:

o  Cross-cutting principles of motivating adherence and behavior change in 
studies aimed at developing models of preventive, treatment, and rehabilitative 
interventions and innovative strategies to enhance adherence to them;

o  Methods of adherence and behavior change that promote incremental change over 
time to sustain the benefits of intervention;

o  The relationship of adherence to intervention response throughout the course 
of the intervention;

o  How competing theories of adherence and behavior change complement each 
other, such as studies simultaneously varying motivation source, degree of self-
efficacy, stage of change, social reinforcement, or norms;

o  How differential patterns of adherence to various components of combined 
interventions influence outcomes;

o  Identifying the general principles of motivation (e.g., intrinsic or 
extrinsic motivation) most effective in encouraging adherence, and identifying 
the most effective emotions, attitudes, states, or beliefs (e.g., negative 
emotions such as fear, or positive attitudes such as an enhanced self-image or 
an appeal to an ideal self);

o  Studies of various theory-based interventions for improving adherence in 
various under-served or high-risk/special-need populations across the life-
course;

o  Strategies containing sub-components that address different adherence-
related behaviors separately, e.g., a project with multiple sub-studies that 
investigate different aspects of a theory for their relevance to different 
behaviors;

o  Studies of how factors underlying adherence or behavior change in one domain, 
for example, interventions aimed at HIV disease, might inform adherence to 
interventions aimed at mental disorders;

o  Studies of factors underlying provider strategies and behaviors that enhance 
recruitment, retention, and adherence;

o  Developing and validating measurements of adherence to pharmacological, 
behavioral, or psychosocial interventions, including self-reports, clinicians' 
observations, and pill counts;

o  Clarifying the characteristics of study participants that may contribute to 
adherence and non-adherence, such as age, gender, ethnicity, level of education, 
occupation, marital status, parental status, socioeconomic status, sexual 
orientation, religion, cultural beliefs about health, and presence of co-morbid 
mental illness;

o  The health provider/client alliance and communication, and how these 
processes affect adherence to complicated, sustained regimens;

o  Studies of increasing client involvement in preventive, treatment, and 
rehabilitative decisions as a way of improving adherence;

o  Research on approaches to decreasing stigma related to mental disorders and 
increasing adherence to interventions, including studies of the social context 
of stigma as well as studies of individuals who are stigmatized; or

o  Research on the potential positive and/or negative impact of various 
informed-consent procedures and other issues related to research ethics on 
adherence to interventions aimed at mental disorders.

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 
sub-populations 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, Vol. 23, No. 
11, March 18, 1994 available on the web at the following URL address:
https://grants.nih.gov/grants/guide/notice-files/not94-100.html

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are scientific and ethical reasons not to include them. This 
policy applies to all initial (Type 1) applications submitted for receipt dates 
after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html 

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

APPLICATION PROCEDURES

Applicants are strongly encouraged to contact the program contacts listed under 
INQUIRIES with any questions regarding their proposed project and the goals of 
this PA.

Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) 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 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, Email: 
GrantsInfo@nih.gov.  Applications are also available on the World Wide Web at: 
https://grants.nih.gov/grants/forms.htm.

SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS

The modular grant concept establishes specific modules in which direct costs may 
be requested as well as a maximum level for requested budgets.  Only limited 
budgetary information is required under this approach.  The just-in-time concept 
allows applicants to submit certain information only when there is a possibility 
for an award.  It is anticipated that these changes will reduce the 
administrative burden for the applicants, reviewers and Institute staff.  The 
research grant application form PHS 398 (rev. 4/98) is to be used in applying 
for these grants, with the modifications noted below.

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up to a 
total direct cost request of $250,000 per year.  (Applications that request more 
than $250,000 direct costs in any year must follow the traditional PHS 398 
application instructions.)  The total direct costs must be requested in 
accordance with the program guidelines and the modifications made to the 
standard PHS 398 application instructions described below:

PHS 398

o  FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total 
Direct plus Facilities and Administrative (F&A) costs] for the initial budget 
period Items 8a and 8b should be completed indicating the Direct and Total Costs 
for the entire proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 
of the PHS 398.  It is not required and will not be accepted with the 
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the 
categorical budget table on Form Page 5 of the PHS 398.  It is not required and 
will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative 
page.  (See https://grants.nih.gov/grants/funding/modular/modular.htm for sample 
pages.)  At the top of the page, enter the total direct costs requested for each 
year.  This is not a Form page.

o  Under Personnel, list key project personnel, including their names, percent 
of effort, and roles on the project.  No individual salary information should be 
provided.  However, the applicant should use the NIH appropriation language 
salary cap and the NIH policy for graduate student compensation in developing 
the budget request.

o  For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the nearest 
$1,000.  List the individuals/organizations with whom consortium or contractual 
arrangements have been made, the percent effort of key personnel, and the role 
on the project.  Indicate whether the collaborating institution is foreign or 
domestic.  The total cost for a consortium/contractual arrangement is included 
in the overall requested modular direct cost amount.  Include the Letter of 
Intent to establish a consortium.

o  Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by 
reviewers in the assessment of each individual's qualifications for a specific 
role in the proposed project, as well as to evaluate the overall qualifications 
of the research team.  A biographical sketch is required for all key personnel, 
following the instructions below.  No more than three pages may be used for each 
person.  A sample biographical sketch may be viewed at: 
https://grants.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on research 
projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

o  CHECKLIST - This page should be completed and submitted with the application.  
If the F&A rate agreement has been established, indicate the type of agreement 
and the date.  All appropriate exclusions must be applied  in the calculation of 
the F&A costs for the initial budget period and all future budget years.

o  The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information is 
necessary following the initial review.

Applications not conforming to these guidelines will be considered unresponsive 
to this PA and will be returned without further review.

Applicants planning to submit an investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended/revised version of 
the preceding grant application types requesting $500,000 or more in direct 
costs for any year are advised that he or she must contact the Institute program 
staff before submitting the application, i.e., as plans for the study are being 
developed.  Furthermore, the application must obtain agreement from the 
Institute staff that the Institute will accept the application for consideration 
for award.  Finally, the applicant must identify, in a cover letter sent with 
the application, the staff member and Institute who agreed to accept assignment 
of the application.

This policy requires an applicant to obtain agreement for acceptance of both any 
such application and any such subsequent amendment.  Refer to the NIH Guide for 
Grants and Contracts, March 20, 1998 at 
https://grants.nih.gov/grants/guide/notice-files/not98-030.html

Any application subject to this policy that does not contain the required
information in a cover letter sent with the application will be returned to the 
applicant without review.

The title and number of the program announcement must be typed on line 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 five signed photocopies in one package to:

CENTER FOR SCIENTIFIC REVIEW
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 evaluated for scientific and technical merit 
by an appropriate scientific review group convened by NIH 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 the appropriate national advisory 
council or board.

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
behavioral and biological systems, improve the control of disease, and enhance 
health.  In the 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.  Note that the 
application does not need to be strong in all categories to be judged likely to 
have major scientific impact and thus deserve a high priority score.  For 
example, an investigator may propose to carry out important work that by its 
nature is not innovative but is essential to move a field forward.

(1) 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?

(2) 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?

(3) 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?

(4) 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)?

(5) 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?

The initial review group will also examine: the appropriateness of proposed 
project budget and duration; the adequacy of plans to include both genders, 
minorities and their subgroups, and children as appropriate for the scientific 
goals of the research and plans for the recruitment and retention of subjects; 
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 recommended 
applications. 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:

Peter Muehrer, Ph.D.
Health and Behavioral Science Research Branch
Division of Mental Disorders, Behavior, and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6190, MSC 9615
Bethesda, MD  20892-9615
Telephone:  (301) 443-4708
FAX:  (301) 480-4415
E-mail:  pmuehrer@nih.gov

Harold Goldstein, Ph.D.
Services Research and Clinical Epidemiology Branch
National Institute of Mental Health
6001 Executive Blvd.; Room 7146, MSC 9631
Bethesda, MD  20892-9631
Telephone: (301) 443-3747 
FAX:  (301) 443-4045
E-mail: goharold@nih.gov 

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-2805
FAX: (301) 443-6885
E-mail:  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, and the NIH Grants Policy Statement, effective 
10/1/98.  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 NIH Grants Policy 
Statement (October 1, 1998).

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, and 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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