DEVELOPMENT OF THEORETICALLY-BASED PSYCHOSOCIAL THERAPIES FOR DRUGDEPENDENCE



NIH GUIDE, Volume 21, Number 34, Part II, September 25, 1992



PA NUMBER:  PA-92-110



P.T. 34



Keywords:

  Drugs/Drug Abuse 

  Psychotherapy 

  Behavioral/Social Studies/Service 



National Institute on Drug Abuse



PURPOSE



The purpose of this announcement is to encourage the development,

refinement, and pilot efficacy testing of theoretically based

psychosocial interventions for drug dependence, including

psychotherapies, behavioral and cognitive-behavioral therapies, and

counseling strategies.  In this Program Announcement (PA), "therapy

development" includes both the development of new therapies and the

modification of existing therapies.  The development of drug dependence

treatment therapies based upon therapy-specific diagnostic approaches

is particularly encouraged.  The ultimate goal of this PA is to

increase the efficacy of drug dependence treatment by developing

therapies that are finely tailored to the specific needs and problems

of the drug-dependent individual.  This announcement is not intended to

support full-scale clinical trials.



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,

Development of Theoretically Based Psychosocial Therapies for Drug

Dependence, is related to the priority areas 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 organizations, public and private, such as universities,

colleges, hospitals, laboratories, units of State and local

governments, and eligible agencies of the Federal government.

Applications from minority individuals and women are encouraged.



MECHANISM OF SUPPORT



Support mechanisms include:  Research Projects (R01), Small Grants

(R03), and First Independent Research Support and Transition (FIRST)

Awards (R29).  Most investigator-initiated research is supported by

research grants.  Research grants are awarded to institutions on behalf

of Principal Investigators who have designed and will direct a specific

project or set of projects.  Most grants can be renewed at intervals or

supplemented through the formal submission and review process described

below.  Except for Small Grants (R03) and FIRST Awards (R29),

investigator(s) may apply for a renewal (competing continuation) of the

project by submitting an application for further support, including a

report of progress and including specific plans for future work.  For

details on a particular support mechanism or program, please contact

the program staff listed at the end of this announcement.  Foreign

institutions are not eligible for the FIRST Award (R29s).



RESEARCH OBJECTIVES



Background



Although several psychosocial treatments for drug-dependent individuals

currently exist, many were initially developed for individuals with

problems other than drug dependence.  While the drug abuse treatment

research community has adapted many of these therapies to meet the

needs of the drug-dependent individual, more can be done in the

development of new, and the modification of existing, therapies for

drug dependence.



Theory-driven therapies specifically created/modified for drug abuse/

dependence treatment need to be operationalized, manualized, measured,

and pilot tested before efficacy testing through rigorously controlled

clinical trials can occur.  As is the case with medications

development, the development of psychotherapeutic and behavioral

interventions is a time consuming and costly procedure.  Until this

point, there has been, paradoxically, support available for the

efficacy testing of drug abuse therapies, but no support for their

initial  development, refinement, and pilot testing.  Based in part

upon recommendations made to the National Institute on Drug Abuse by

experts in the drug abuse treatment field, this program announcement

intends to provide support for this endeavor.



Specific Areas of Interest



Investigators are encouraged to submit applications to develop new or

modify existing psychosocial therapies that:  (1) appear promising for

the treatment of drug-dependent individuals and (2) have a convincing

rationale.  Therapies of interest include, but are not limited to, the

following:



o  Diagnosis-specific or client characteristic-specific theoretically

based therapies for drug dependence.  Such therapies are based upon

theories regarding measurable psychological, behavioral, or

interpersonal constructs.  Examples include therapies to overcome

cognitive deficits, family dysfunction, or social skill deficiencies,

where "diagnoses" may be given regarding the relevant cognitive

abilities, family functioning, or social skills.  As appropriate,

investigators are encouraged to propose the development of relevant

diagnostic instrument(s) in addition to the development of the therapy,

in their applications.



It should be noted that in the context of this PA, "diagnosis" is not

limited to traditional DSM-III-R or DSM-IV classification.  Rather, it

may refer to any measurable, theoretically based psychological,

behavioral, or interpersonal construct.



o  Theoretically-based therapies to treat dependence upon certain types

of drugs (e.g., cocaine, heroin, marijuana, benzodiazepines).

o  Theoretically-based therapies to treat particular clients with one

or more co-morbid mental disorders (e.g., mood, anxiety, or personality

disorders).

o  Theoretically-based therapies to treat clients of a particular

ethnic, racial, or cultural group where it is hypothesized that a

therapy geared specifically toward that group will be more effective

than currently existing therapies.

o  Theoretically-based therapies oriented to the special needs of

women.

o  Any drug dependence therapy or counseling strategy, including

therapies which are "eclectic"  or pragmatically based, that have a

convincing rationale.



A goal of this PA is to encourage projects involving the development of

new or refinement of existing therapies and counseling strategies which

are based upon a theoretical rationale.  Therapy development

applications should include an explicit statement describing the

theoretical and clinical basis for that therapy, and the population for

whom it is intended.  Applicants proposing the development of

"eclectic" or "pragmatic" therapies, which may not be tied to a single

theoretical orientation, should describe the rational, practical and

clinical basis for the therapy. Diagnosis-specific or client

characteristic-specific therapies are particularly encouraged for

development.  A thorough literature review documenting and explaining

relevant research and clinical findings which support and apparently

contradict the stated rationale should be included.  Relevant clinical

observations and anecdotal reports are particularly encouraged where

relevant research findings are lacking.  The nature of the therapy to

be developed should be described in as much detail as possible.

Components of the therapy or counseling approach to be developed should

be operationally defined wherever possible.



Applicants proposing diagnosis-specific or

client-characteristic-specific therapies must address the issue of

whether there is a need for development of theoretically based

diagnostic systems or client assessment scales tailored to their

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 should either exist, or be developed

with a therapy based upon treating these conflicts.  The development of

a theoretically based therapy should include measures of client

attributes directly related to that therapy.  As part of the research

activity supported under this announcement, investigators are

encouraged to develop new or refine existing diagnostic systems/client

assessment scales necessary to measure the impact of the proposed

theoretically based therapy.  Methods that will be used to develop

these instruments should be described in detail.  Close attention

should be paid to the psychometric characteristics of these measures

(i.e., their validity, internal consistency, inter-rater and

test-retest reliability).



Applicants must also address the issue of how they intend to measure

what is actually occurring in the therapy they are proposing to

develop.  The credibility of any treatment research depends on our

ability to determine the extent to which that treatment was actually

administered, and administered correctly.  In the development of any

therapy, therefore, emphasis should be placed upon the development of

psychometrically sound therapist competence and adherence scales,

process measures, and instruments measuring the integrity and fidelity

of the therapy.  Applicants must describe the instruments they intend

to develop, and the methods that they will use to ensure they are

developing valid and reliable measures.



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

of issues relevant to efficacy and safety should be addressed.  Pilot

efficacy testing of newly developed/modified therapies, therefore,

should be considered an integral part of any therapy development

process.  The applicant must describe, in detail, the nature of any

pilot testing proposed.  While a full-scale, controlled clinical trial

of a therapy is not expected as part of this PA, any pilot testing

proposed must be based upon sound, scientific methods.



When pilot testing, if a subject is identified as being at risk for HIV

acquisition and/or transmission, HIV testing and counseling should be

offered to the subject in accordance with current guidelines.

Furthermore, in high-risk populations, investigators are encouraged to

assess the effect of the new therapy on the acquisition/transmission of

associated infectious disease, including HIV.



STUDY POPULATIONS



NATIONAL INSTITUTES OF HEALTH (NIH) POLICY CONCERNING INCLUSION OF

MINORITIES AND WOMEN AS SUBJECTS IN RESEARCH



Applications for grants and cooperative agreements and proposals for

contracts that involve human subjects are required to include

minorities and both genders in study populations so that research

findings can be of benefit to all persons at risk of the disease,

disorder, or condition under study; special emphasis should be placed

on the need for inclusion of minorities and women in studies of

diseases, disorders, and conditions which disproportionately affect

them.  This policy applies to all research involving human subjects and

human materials, and applies to males and females of all ages.  If one

gender and/or minorities are excluded or are inadequately represented

in this research, particularly in proposed population-based studies, a

clear compelling rationale for exclusion or inadequate representation

should be provided.  The composition of the proposed study population

must be described in terms of gender and racial/ethnic group, together

with a rationale for its choice.  In addition, gender and racial/ethnic

issues should be addressed in developing a research design and sample

size appropriate for the scientific objectives of the study.



Applicants are urged to assess carefully the feasibility of including

the broadest possible representation of minority groups.  However, the

NIH recognizes that it may not be feasible or appropriate in all

research projects to include representation of the full array of United

States racial/ethnic minority populations (i.e., American Indians or

Alaskan Natives, Asians or Pacific Islanders, Blacks, Hispanics).

Investigators must provide the rationale for studies on single minority

population groups.



Applications for support of research involving human subjects must

employ a study design with minority and/or gender representation (by

age distribution, risk factors, incidence/ prevalence, etc.,)

appropriate to the scientific objectives of the research.  It is not an

automatic requirement for the study design to provide statistical power

to answer the questions posed for men and women and racial/ethnic

groups separately; however, whenever there are scientific reasons to

anticipate differences between men and women, and racial/ethnic groups,

with regard to the hypothesis under investigation, applicants should

include an evaluation of these gender and minority group differences in

the proposed study.  If adequate inclusion of one gender and/or

minorities is impossible or inappropriate with respect to the purpose

of the research, because of the health of the subjects, or other

reasons, or if in the only study population available there is a

disproportionate representation of one gender or minority/majority

group, the rationale for the study population must be well-explained

and justified.



The NIH funding components will not make awards of grants, cooperative

agreements or contracts that do not comply with this policy.  For

research awards which are covered by this policy, awardees will report

annually on enrollment of women and men, and on the race and ethnicity

of subjects.



APPLICATION PROCEDURES



Applications are to be submitted on the research grant application form

PHS 398 (rev. 9/91) and will be accepted at the standard application

deadlines as indicated in the application kit.  The special receipt

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

398 instructions.  Application kits are available at most institutional

business offices and from the Office of Grants Inquiries, Division of

Research Grants, National Institutes of Health, Westwood Building, Room

449, 5333 Westbard Avenue, Bethesda, MD 20892, telephone (301)

496-7441.  The title and number of the announcement must be typed in

Item 2a on the face page of the application.



FIRST Award applications must include at least three sealed letters of

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

Award 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 of the

complete application 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 PHS referral

guidelines.  Applications will be reviewed for scientific and technical

merit by an initial review group in accordance with the standard NIH

peer review procedures.  Following scientific-technical review, the

applications will receive a second-level review by the appropriate

National Advisory Council.  Small grant (R03) applications assigned to

the NIDA do not receive a second-level review.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications.  The following will be considered in making funding

decisions:



o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Institute program needs and balance



INQUIRIES



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.



Direct inquiries regarding programmatic issues to:



Dr. Lisa Onken

Treatment Research Branch

National Institute on Drug Abuse

5600 Fishers Lane, Room 10A-30

Rockville, MD  20857

Telephone:  (301) 443-4060



Direct inquiries regarding fiscal matters to:



Mrs. Shirley Denney

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 Sections 301 and

405 of the Public Health Service Act (42 USC 241 and 284) 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.



.

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