BEHAVIORAL THERAPIES DEVELOPMENT PROGRAM

NIH GUIDE, Volume 22, Number 26, July 15, 1994



PA NUMBER:  PA-94-078



P.T. 34



Keywords:

  Drugs/Drug Abuse 

  Behavioral/Social Studies/Service 

  Rehabilitation/Therapy, Emotional 

  0745007 

  Psychotherapy 



National Institute on Drug Abuse



PURPOSE



The purpose of this program announcement (PA) is to firmly establish

the ongoing commitment of the NIDA to a major program of research on

behavioral therapies for drug abuse and dependence.  The term

"behavioral therapy" is used here in a broad sense and includes various

forms of psychotherapy, behavior therapy, cognitive therapy, skills

training, counseling, and other rehabilitative therapies.  Behavioral

therapy research has been conceptualized, for the purposes of this

initiative, to consist of three stages: (1) Stage I research (including

the development, refinement, and pilot efficacy testing of behavioral

interventions); (2) Stage II research (efficacy testing and replication

of promising piloted behavioral therapies); and (3) Stage III research

(studies to test the transferability to the community of behavioral

therapies proven efficacious in Stage II studies).



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,

Behavioral Therapies Development Program, is related to the priority

area of alcohol and other drugs. 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 202-783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by foreign and domestic, for-profit and

non-profit organization, public and private, such as universities,

colleges, hospitals, laboratories, units of State or local governments,

and eligible agencies of the Federal government.  Applications from

minority individuals and women are encouraged.  Foreign institutions

are not eligible for First Independent Research Support and Transition

(FIRST) Awards (R29).



MECHANISM OF SUPPORT



Support mechanisms include:  research project grants (R01), small

grants (R03), cooperative clinical research grants (R10) and FIRST

Awards (R29).  Investigators may also respond to this program

announcement under the Interactive Research Project Grant  (IRPG)

Program.  If an investigator wishes to respond under an IRPG,

additional requirements must be met as described in PA-93-078.

Research grants are awarded to institutions on behalf of Principal

Investigators who have designed and will direct a specific project or

set of projects.  In fiscal year 1995, it is estimated that NIDA will

have approximately $10 million to support approximately 30 new grants

under this announcement.



RESEARCH OBJECTIVES



Background and Rationale.  Behavioral therapies are frequently the only

treatments available to drug dependent individuals. Even where

medications are available, behavioral therapies are an integral

component of treatment.  Recognizing the importance of this area, the

NIDA has launched a Behavioral Therapies Development Program.  It is

intended to:  (1) complement and dramatically expand work underway

within the Clinical and Experimental Therapeutics  Research Branch,

Division of Clinical Research, NIDA; and (2) parallel NIDA's

Medications Development Program.  It is NIDA's intention to support

scientifically sound and clinically relevant behavioral therapy

research that will potentially have a meaningful impact on the efficacy

of drug abuse/ dependence treatment.  Due to the growing AIDS problem

in this country, special consideration will be given to grants that

address AIDS- related issues in their therapies and include measures of

the effect of the therapies on AIDS risk behaviors.  Through the

Behavioral Therapies Development Program, support may be sought to

identify, evaluate, and standardize behavioral therapies for the

treatment of drug abuse and dependence.  Ultimately, therapies found to

be efficacious through rigorous testing will be disseminated to

clinicians.  Although substantial work has already been done, this

initiative will target for funding, in a systematic way, essential

research on behavioral therapies for drug abuse and dependence.  This

will include, in particular, critical areas of research that have been

overlooked in the past.



Recent results from research studies indicate great promise for the

efficacy of behavioral therapies for drug dependence.  While

considerable progress has been made, engagement and retention in

treatment and relapse following treatment remain concerns.  NIDA has

undertaken the Behavioral Therapies Development Program with the goal

of addressing these concerns and substantially improving the efficacy

of behavioral treatments for drug abuse.  The NIDA's Behavioral

Therapies Development Program delineates three stages of behavioral

therapy research.  Stage I, the earliest stage of behavioral therapy

research, therapy development, is viewed as a process involving

identifying promising clinical and research findings relevant to drug

abuse treatment, generating and formulating new behavioral therapies,

operationally defining the therapies in manuals, and pilot testing and

refining the therapies.



Stage II research consists of small-scale efficacy testing of promising

therapies identified in Stage I, as well as studies examining the

efficacy of components of therapies.  Most of the behavioral treatment

research that NIDA has supported in the past has been of this type.

Stage II also involves the replication, at other sites, of efficacy

studies with positive results.



Stage III entails the testing of the transferability to the community

of therapies that have been shown to be efficacious in more than one

controlled Stage II clinical trial.   That is, Stage III, as defined in

this program announcement, involves the determination of the usefulness

of a therapy within community- based treatment programs.  In order to

meet the goals of Stage III research, investigators may wish to propose

the development of training materials for the community drug abuse

treatment provider.



It is NIDA's objective to ensure sufficient emphasis and support for

all stages of behavioral therapy research.  Through the Behavioral

Therapies Development Program, NIDA will greatly increase its support

of the early stages of behavioral therapy development, small-scale

controlled clinical trials of fully- developed therapies (including

replications), and studies in community-based treatment programs of the

most promising therapies identified in the Stage II clinical trials.

This PA is intended to introduce this initiative by encouraging

research grant applications in any one of the three stages of

behavioral therapy research.



Specific Areas of Interest



Stage I Research.  Investigators are encouraged to submit applications

to develop and pilot test new or to modify and pilot test existing

individual, group or family behavioral therapies that (1) appear

promising for the treatment of drug dependent and abusing individuals

and (2) have a theoretical basis and/or logical rationale.  For drug

abusers/addicts at high risk for AIDS, investigators are encouraged to

include AIDS risk reduction interventions as an integral component of

the therapy.  Wherever appropriate, applicants are strongly encouraged

to address how they will incorporate AIDS risk reduction strategies

into the therapies they are proposing to develop.  Of particular

interest for development are:  (1) discrete therapy modules, such as

HIV risk reduction modules or modules to engage ambivalent drug

dependent individuals in treatment, that can be implemented in

conjunction with other therapeutic services; (2) therapies to treat

populations with co-occurring drug abuse and mental problems; (3)

therapies that address the unique needs and perspectives of women,

minorities, adolescents, families, or specific cultural groups; (4)

group therapies; and (5) therapies for HIV- positive drug

abusers/addicts.



Applicants proposing to develop a therapy are encouraged to explicitly

describe the theoretical basis for the proposed therapy, and the

population for whom it is intended.  Although, of course, a manual for

a therapy will not exist prior to an application to develop such a

manual, applicants are encouraged to describe in as much detail as

possible the nature of the therapy to be developed.



Where appropriate, applicants may seek support under this program

announcement to develop theoretically-based and psychometrically- sound

client assessment scales tailored to assess the specific effects of the

proposed therapy.  If one theorizes, for example, that certain heroin

addicts either began or maintained heroin use due to interpersonal

conflicts, and that the resolution of these conflicts will decrease

drug use, a measure of interpersonal conflicts may be required to

ascertain the impact of the therapy under development.



Applicants are encouraged to address the issue of therapy process

measurement.  Where appropriate, applicants may propose to develop

measures of therapist competence and adherence, process measures, and

instruments measuring the integrity and fidelity of the therapy.



In the development of a new therapy for drug dependence, a broad range

of issues relevant to efficacy and safety are raised. Pilot efficacy

testing of newly developed/modified therapies is an integral part of

any therapy development process.  Therefore, applicants are encouraged

to describe, in detail, the nature of any pilot testing intended.



Wherever appropriate, applicants are encouraged to collect pilot data

on the impact of the therapy on AIDS risk behavior, including data on

the route of drug administration, and sexual behavior that may place

individuals at risk for AIDS. Stage II Research.  According to the

model described in this program announcement, Stage II research

establishes the efficacy of behavioral therapies or therapy components

shown to be promising in Stage I.  Therefore, it is strongly suggested

that Stage I pilot data showing that a behavioral therapy is promising

(in terms of a reduction in drug use, dropout rate, or psychiatric

symptoms) be provided when proposing a Stage II controlled clinical

trial.  In Stage II research, control and comparison conditions are

operationally defined, standardized, and manualized.  However, early in

Stage II, it may be appropriate to compare a therapy with "treatment as

usual."  Of course, control/comparison conditions are determined by

clearly delineated research questions.  It is appropriate, but not

required, that investigators design studies to answer not only if their

therapy works, but why it works.  Where investigators are studying

populations that are at risk for HIV, they are encouraged to explicitly

address AIDS-related issues in their applications.



Controlled clinical trials that examine the relative efficacy of

individual, group, or family behavioral therapies and attempt to

determine which therapies are best for which individuals, and under

what conditions, are considered Stage II research.  Where effective

pharmacotherapies are available, research projects that attempt to

maximize the efficacy of that pharmacotherapy through integration with

behavioral therapy, or vice versa, are encouraged.



Knowing the effective components of treatment can greatly aid in

improving the quality of treatment.  Theoretically based research that

attempts to determine the effective components or combination of

components in drug dependence psychotherapies, behavior therapies, or

counseling strategies is encouraged.



Where positive Stage II findings exist, replications are strongly

encouraged.  Applications that propose to generalize the efficacy of a

promising therapy in another population are also encouraged. Where the

investigator believes that significant modification of the therapy is

needed before it can be tested in another population, investigators are

referred to the section of this PA entitled, "Stage I Research."



Investigators proposing a Stage II controlled clinical trial are

encouraged to address pertinent methodological/design issues in their

applications, such as attrition, selection bias, therapist/counselor

training, assessment and control for patient psychiatric diagnosis and

problem severity level, the use of manuals to guide the therapy,

measurement of the treatment process, adequate follow-up assessments,

and potential replication of the research proposed.  It is recognized

that for many research questions asked in the field of psychotherapy,

behavior therapy, and counseling, no perfect research design may exist.

Where there is more than one way to answer a proposed research

question, investigators are urged to state their theoretical, ethical,

and practical reasons for choosing one control group or one research

design over another.



Stage III Research.  Where a behavioral therapy has been shown to be

efficacious in a clinical trial, and where replication by a different

investigator has borne out the contention that the therapy is, indeed,

efficacious, investigators may propose to carry out a study to address

the therapy's transferability to a community setting.  A therapy that

has been shown to be efficacious in a Stage II clinical trial and a

replication is a possible candidate for a Stage III study.  An

investigator may propose to do a Stage III study on a therapy that was

determined to be efficacious in Stage II by themselves or other

investigators.



Stage III may include packaging a therapy for use by a community drug

abuse treatment provider and developing training manuals and other

training materials.  The investigator might then pilot the therapy in

the community clinic, refine the therapy package, and ultimately test

the usefulness of the packaged therapy in the community setting.



Applicants are strongly encouraged to develop applications that are

focused on one stage.  That is, investigators may choose to focus on

either Stage I, Stage II or Stage III research.  However, where

necessary, investigators may develop applications to include a research

component consistent with the another stage (e.g., a Stage II research

application may include a small Stage I component).



If a subject is identified as being at risk for HIV acquisition and/or

transmission, HIV testing and counseling must be offered to the subject

in accordance with current guidelines.  Wherever appropriate,

investigators are encouraged to collect data on the effect of their

behavioral therapy on AIDS risk behaviors and the effect of their

therapy on the acquisition/transmission of associated infectious

disease, including HIV.



STUDY POPULATIONS



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 new 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 28, 1994 (FR 59 11146-11151), and reprinted

in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23,

Number 11.



Investigators may obtain copies from these sources or from the program

staff or contact person listed below.  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.  The receipt dates for

applications for AIDS-related research are found in the PHS 398

instructions.  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 240, Bethesda, MD  20892, telephone

(301) 710-0267.  The title and number of the program announcement must

be typed in Section 2a on the face page of the application.



FIRST applications must include at least three sealed letters of

reference attached to the face page of the original application.  FIRST

applications submitted without the required number of 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

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW CONSIDERATIONS



Applications will be assigned on the basis of established Public Health

Service referral guidelines.  Applications will be reviewed for

scientific and technical merit in accordance with the standard peer

review procedures.  Following scientific-technical review, the

applications will receive a second-level review by the appropriate

national advisory council.  Small grant applications (R03) assigned to

NIDA do not receive a second-level review.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications assigned to that Institute/Center/Division. At NIDA,

special consideration will be given to applications that directly deal

with AIDS-related issues.  The following will be considered when making

funding decisions:



o  Scientific and technical merit of the proposed project as determined

by peer review

o  Availability of funds

o  Institute/Center/Division program needs and balance



INQUIRIES



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applications is welcome.



Direct inquiries regarding programmatic issues to:



Dr. Lisa Onken

Clinical and Experimental Therapeutics Branch

National Institute on Drug Abuse

5600 Fishers Lane, Room 10A-30

Rockville, MD  20857

Telephone:  (301) 443-0107

INTERNET:  [email protected]



Direct inquiries regarding fiscal matters to:



Dr. Gary Fleming, Chief

Grants Management Branch

National Institute on Drug Abuse

5600 Fishers Lane, Room 8A-54

Rockville, MD  20857

Telephone:  (301) 443-6710



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic Assistance

No. 93.279.  Awards are made under authorization of the Public Health

Service Act (42 USC 241 and 290cc) and administered under PHS grants

policies and Federal Regulations at Title 42 CFR Part 52, "Grants for

Research Projects," Title 45 CFR part 74 & 92, "Administration of

Grants," and 45 CFR Part 46, "Protection of Human Subjects."  Title 42

CFR Part 2 "Confidentiality of Alcohol and Drug Abuse Patient Records"

may also be applicable to these awards.  This program is not subject to

the intergovernmental review requirements of Executive Order 12372 or

Health Systems Agency review.  Sections of the Code of Federal

Regulations are available in booklet form from the U.S. Government

Printing Office.  Awards must be administered in accordance with the

PHS Grants Policy Statement, (Rev., 4/94), which may be available from

the institutional office of sponsored research.



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