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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