Regulations for the funding measure “Psychotherapy research”

Announcement of the Federal Ministry of Education and Research (BMBF) [December 14, 2004, deadline: March 31, 2005]

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1. Funding purpose and legal basis

Mental disorders belong to the most important disease groups. They have a lifetime prevalence of 30 % and are often responsible for early retirement and sickleave. Due to the demographic development of the population in Germany it is expected that the frequency of mental disorders and their impact on the health care system will increase.
Psychotherapeutic interventions of various kinds are routinely applied in the treatment of many mental diseases. To date, psychotherapeutic treatments play an important role in the national health care system.
However, only few validated facts exist on the efficacy and the effectiveness of psychotherapeutic interventions. There are still deficiencies in the diagnostic classification and the indication of appropriate treatments. The development of standardised instruments to map and validate the effectiveness of psychotherapeutic interventions as well as the standardisation of different therapies are partially unsatisfactory. The rapid recent progress in neurobiological and neurophysiological research has yielded many important aspects that may also help to provide better theoretical understanding of the effect of a psychotherapeutic intervention. These recent techniques should be integrated in future psychotherapy research.

Psychotherapy research in Germany is conducted by researchers coming from various scientific disciplines like psychiatry, psychosomatics and clinical and medical psychology. Aim of the present funding measure is to advance psychotherapy research, to improve the interdisciplinary cooperation in the field and to ameliorate the structural conditions. The accelerated transfer of scientific results into heath care is another goal.
For this reason, the Federal Ministry of Education and Research (BMBF) intends to support up to four nationwide networks, dedicated to a single specific disorder or a group of closely related disorders. Funding will occur within the framework of the Federal Government's "Health Research: Scientific Research for the People" programme and would include provisions for a network-wide organisation and communication structure as well as for specific research projects.
Projects will be supported with grants awarded in accordance with the present funding regulations, the BMBF's standard terms and conditions for grants on expenditure or cost basis and the administrative regulations under section 44 of the Federal Budget Code (BHO). Applicants have no legal claim to a grant. The grant-awarding agency will take its decision after due assessment of the circumstances. The funding measure is subject to the proviso that the budget funds and commitment authorizations required for implementing it are available to the BMBF.

2. Object of funding

The aim of the funding measure is to establish nationwide networks of renowned research institutions. Each network should be dedicated to a specific mental disorder. Eligible partners are universities, other research institutions and research bound clinics. To improve the transfer of knowledge from research into daily clinical practice and to enable the exemplary introduction of new treatment strategies the networks shall create local and regional networks with outpatient clinics and practising medical professions. The early integration of health insurance companies and institutions of the social security system into the networks is regarded as an asset.

Single projects without a network cannot be funded.

The networks should concentrate on the following research topics:
A. Outcome and process research in the psychotherapeutic treatment of specific mental disorders (group of closely related disorders)
Investigating the mode of action and the effectiveness of various psychotherapeutic methods is a prerequisite to a better understanding and the advancement of psychotherapy. Therefore networks should perform outcome and process research including trials comparing a psychotherapeutic method with another and/or with pharmacotherapy. Clinical trials aiming at the approval of a pharmacological substance are not fundable.
B. General conditions and praxis transfer
The effectiveness of validated psychotherapeutic methods depends to great extent on structural conditions which are imposed by the national health care system. Hence, studies are needed which aim at analysing the needs and the reality in medical care, and the structural quality of the health care system regarding the requirements of effective psychotherapeutic interventions. The development of guidelines as well as the introduction and dissemination of evidence-based methods in daily psychotherapeutic practice should be endeavoured.
C. Interaction of neurobiological and psychosocial factors
Investigating the interactions of neurobiological and psychosocial factors in the aetiology and persistence of mental disorders are issues of growing interest in psychotherapeutic research. This includes especially the characterisation of neurobiological predictors of therapy success. Research in this field is expected to contribute to an advancement of individually tailored therapies including also the individual combination of psycho- and pharmacotherapy. Those projects must correlate with the subject of the clinical subprojects of the network.
D. Age and gender-related  dimensions of psychotherapeutic research
So far, psychotherapy research has concentrated on adults. Therefore research projects concerning psychotherapy with children and elderly people are another aim of the funding measure. Gender-specific aspects should be adequately addressed as well.

3. Grant recipients

State and non-state institutions of higher education, non-university research establishments, institution of health care delivery (hospitals and rehabilitation clinics) may submit applications.
Each network should nominate a network speaker.
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7. Procedure

7.1. The BMBF´s project management organisation

The Federal Ministry of Education and Research has entrusted the following project management organisation with implementing the funding activity:

Projektträger DLR des BMBF
Gesundheitsforschung
Heinrich-Konen-Str. 1
53227 Bonn
Tel: + 49 228-3821-210
Fax: + 49 228-3821-257

Applicants are advised to contact the scientific staff member of the project management agency (Dr. Martin Goller (+ 49 228-3821-269) or Dr. Detlef Böcking (+ 49 228-3821-118) before submitting the application in order to obtain comprehensive information.
Applications for clinical trials have to reach international standards (http://www.ich.org/, http://www.consort-statement.org/). Please refer to the additional guidelines for grant application when preparing your proposal.

7.2 Submission of project outlines

The grant application and evaluation is a two-step procedure. Applications can be submitted from now until

31 March 2005

The grant application may not exceed five pages for the network structure and two to three pages for each subproject (five pages for clinical trials).
Grant applications must be written in English and submitted to the project management organization in 15 copies (double-sided, in DIN A4 format, Arial point 11) and as MS Office-compatible pdf document (CD-ROM or diskette).
The deadline for submission is not a cut-off deadline. It is possible that project outlines which are received belatedly may not be considered.
No legal claim can be derived as a result of the submission of an application.
 
7.3. Selection and decision-making procedure

As one part of the selection process, project outlines received will be submitted to an international, independent jury for evaluation.
The criteria to be applied will include the following:
- innovative potential and clinical relevance of the application
- scientific quality and prospects of success of the project,
- previous work,
- multidisciplinarity,
- integration of the expertise and capacities (or efficient access) required for achieving the objectives,
- structure of the network,
- dimension of synergy effect to expect,
- planned measure to transfer results into daily health care,
- contribution to the promotion of young scientists and patient information
- public relation activities
The applicants will be informed in writing about the results of the evaluation. If evaluated positively, they are invited to submit an extended proposal which will be evaluated again by the international jury.
Networks succeeding a midterm evaluation after approximately 2.5 years may be funded for a second 3-year period to consolidate their work.
Approval and payment of and accounting for the funds as well as proof and examination of proper use and, if necessary, revocation of the award and reclaiming of the funds awarded are governed by the administrative regulations under section 44 of the Federal Budget Code (BHO) and sections 48 and 49a of the Administrative Procedure Act (VwVfG) unless deviation is allowed under the present funding regulations.
 
8. Entry into force

These funding regulations will enter into force on December 14, 2004.

Berlin, December 3, 2004

Federal Ministry of Education and Research     

Dr. Gabriele Hausdorf

Head of Health Research Division