Methods Paper of the Scientific Psychotherapy Council, according to §11 PsychThG
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Methods Paper of the Scientific Psychotherapy
Council, according to §11 PsychThG
Regulations for assessing the scientific recognition
of psychotherapeutic methods and procedures.
Methods Paper of the Scientific Psychotherapy Council, according to §11 PsychThG
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Table of Contents
I.
Basis of the assessment of scientific acknowledgement of psychotherapy methods and procedures. ........... 3
I.1
Psychotherapeutic Procedures and Methods .............................................................................................. 3
I.2
Scientific Recognition ................................................................................................................................. 5
I.3
Applications of Psychotherapy .................................................................................................................... 7
II.
Procedures of assessing the scientific recognition of Psychotherapy Methods and Procedures ...................... 8
II.1 Classification as a psychotherapy process or psychotherapy method .......................................................... 8
II.2 Compilation of Studies ............................................................................................................................... 9
II.3
II.3.1
Assessment of the Individual Trials, concerning the Efficacy of Psychotherapeutic Methods and Procedures. .............. 10
Determining the Subject of Inquiry 10
II.3.2
Assessment of the general Methodological Quality of a Study ......................................................... 10
II.3.3
Assessment of the Internal Validity of a Study .................................................................................. 11
II.3.4
Assessment of the External Validity of a Study.................................................................................. 11
II.3.5
Evaluation of the Study ...................................................................................................................... 11
II.3.6
Consideration of Single-Case Studies ................................................................................................. 12
II.3.7
Focus on Older Studies ...................................................................................................................... 12
II.4 Scientific Recognition of Psychotherapy-Methods and Procedures.......................................................... 13
III.
II.4.1
Scientific Recognition of Psychotherapy-Methods and Procedures for Individual Psychotherapy
Applications ....................................................................................................................................... 13
II.4.2
Scientific Recognition of Psychotherapy Methods for the Treatment of Eating Disorders ............... 13
Recommendations for the Training of the Psychological Child and Adolescents Psychotherapists ........... 14
III.1 Recommendations for the training to become a Psychotherapist ................................................................. 14
III.2 Recommendations for Training Children’s and Adolescents Psychotherapists .............................................. 15
Attachment .................................................................................................................................................................. 16
1.
Criteria for the assessment of Studying the Quality of Psychotherapy Studies ........................................ 16
2.
Application of Psychotherapy in Adults, as well as in Children and Adolescents ...................................... 23
Methods Paper of the Scientific Psychotherapy Council, according to §11 PsychThG
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I.
Basis of the assessment of scientific acknowledgement of
psychotherapy methods and procedures.
From the beginning of the Scientific Psychotherapy Council, the council has tried to set up criteria and
rules for the assessment of academically recognizing psychotherapeutic procedures, and this was
published on the website: http://www.wbpsychotherapie.de. Due the experience gained so far, the
Scientific Psychotherapy Council decided to clarify and further on develop these regulations. The reasons
for such actions are due to legal consents for scientific- and methodological development, and the
general discussion on the evidence based medical nature of psychotherapeutic treatments.
The aim of amending the rules is to establish a scientific basis for the recognition of a structured, and
transparent, process. This is to enable an identical evaluation for all possible psychotherapy-methods
and –procedures.
I.1
Psychotherapeutic Procedures and Methods
In § 8 Paragraph 3 of the psychotherapist-laws (PsychThG) it is stated that: “the training need a basic skill
in scientific depth, as well as an in-depth training in one of these method.” In § 11 of the PsychThG, it is
stated that cases that are of in doubt, will be judged and assessed by the Scientific Psychotherapy
Committee to see if it will be acknowledged or not.
In the extended publication of the psychotherapist-laws (Behnsen & Bernhardt, 1999), it is noted that as
soon an individual has entered into the psychotherapist-laws as a socially recognized therapist of
analytical psychotherapy, psychodynamic psychotherapy and/or behavioural therapy, and that person is
to follow the scientific rules defined in the PsychThG. In section B.I of the guidelines, the analytical
psychotherapy, the psychodynamic psychotherapy and the behavioural therapy are marked as
“procedures, which have a comprehensive theory of pathogenesis and for which specific treatments are
covered in their therapeutic efficacy”.
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In research, new treatment methods are increasingly being produced and amended, however, there still
is no comprehensive psychotherapy procedure. Due to this fact, the scientific psychotherapy council was
asked on multiple occasions to ascertain the scientific acknowledgment/recognition of
psychotherapeutic methods. This establishes the necessity to decide if a psychotherapeutic
approach/beginning is a psychotherapy procedure, or a psychotherapy method. Hence, the Scientific
Psychotherapy Council has the following understanding of psychotherapy-procedures, psychotherapymethods, and psychotherapy-techniques1:
Psychotherapy-Procedures
A suitable psychotherapy-procedure treatment is defined by:
An extensive knowledge of the theory of the origin and maintenance of illnesses, and their
treatment
And
A psychotherapeutic treatment strategy for a broad spectrum in applications, or other specific
psychotherapeutic treatment strategies that have a wide range of applications,
And
A concept for the indication, individual treatment plan, and creation of the therapeutic
relationship.
A scientific and acknowledged psychotherapy procedure must fulfil the conditions stated in points II.5
and III.
Psychotherapy-Methods
A treatment of one or more disorders with the appropriate psychotherapy-method is defined by:

A theory of the origin and maintenance of the designated disorder(s), and the theory of its
treatment,

Indication-criteria including their diagnostic acquisition.

The description of the procedure

The description of the intended treatment effect
And
A scientific and acknowledged psychotherapy method must fulfil the conditions stated in point II.5.
1
The definition of procedures, methods, and techniques occurred in the agreement with the “Gemeinsamen
Bundesausschuss.
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Psychotherapy-Technique
A psychotherapeutic technique is a concrete approach with which the intended psychotherapeutic goal
is to be achieved, with the appliance of psychotherapeutic methods and procedures. For example, in the
field of psychodynamic procedures: the transfer of increasing awareness of unconscious relationship
patterns, or in behavioural therapy: stimuli confrontation.
The scientific psychotherapy council checks the scientific acknowledgement of procedures and
independent psychotherapeutic methods. Methods that are categorized as a procedure, will not be
validated on behalf of their scientific acknowledgement, but simply be checked by their relation to the
procedural review.
I.2
Scientific Recognition
The scientific psychotherapy council is in accordance with its terms, and takes the assumption that
psychotherapy-procedures or psychotherapy-methods are to be based on the results that have been
achieved. It is necessary to mention that the Scientific Psychotherapy Council as an institution does not
make any research of their own, but inspects and evaluates the research-papers completed by the
national or international third party.
§ 1 paragraph 3 in the psychotherapist-laws defines the practice of psychotherapy as: “any recognized
and scientifically means of psychotherapeutic processes made to identify, cure or lessen the patients
disorder with clinical significance”. According to this definition of psychotherapy, the Scientific
Psychotherapy Council believes that the scientific recognition of a psychotherapeutic-process is
determined by the scientific implementation in the practice to cure or lessen the patients’ disorder.
The scientific research works on multiple inquiries about psychotherapy, such as; the efficacy, its effects,
the use in practice, their contribution to welfare, and more. For the assessment and recognition of
scientific psychotherapeutic-procedures and –methods, one needs enough proof to display the
effectiveness of the particular treatment in practice, with the desired effect of healing or improving
disorders. Therefore, there are a set of criteria for determination of such assessments:

Criterion 1: The use of interventions on people that suffer from disorders with clinical
significance, which leads to an observable therapeutic healing effect.
The scientific results are only taken under consideration and acknowledgeable of the treatment was
given to a person with a clinical mental disorder. Furthermore, the achieved criterion is only considered
when the “Detection, cure, or alleviation of disorders with clinical significance” has been reached (more
information is under point II.2.5).

Criterion 2: The observed therapeutic effect is inter-subjectively identifiable and replicable.
The impression that a treatment was successful, from the view of the patient and therapist, must be
tested by controlled, objective, reliable and valid measurements. Furthermore, the effect of the
psychotherapeutic-process can only be established if that certain effect can be repeated in an
independent study, also under controlled conditions (more information under II.4.2)
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
Criterion 3: The reached effect must have a high probability to be traceable back to the
therapeutic intervention (internal validity).
It must be observable that the desired effect was really reached through the treatment procedures, and
not through other factors – intentional or not. The rules for proving this are:
o
o
o
A controlled group is set up with patients getting a different treatment or different
therapeutic procedures. The control group may also receive no treatment, a placebotreatment, or a treatment that would usually be given but which would result in a
different outcome,
or, the group of patients receiving the investigated psychotherapeuticmethod/procedure achieve an outcome that is at least no worse than the group of
patients receiving another treatment, which is already proven to have worked,
or, a series of individual case studies who a systematic relation between the method-use
and the desired effect.
These verifications can generally be done under research-conditions, or practice-conditions (more
information in II.4.3)

Criterion 4: The investigated psychotherapeutic intervention can effectively be replicable in
practice (external validity)
Internal and external validity
The question of the internal and the external validity are different, and the answer requires the
consideration of every different methodological rule. In most cases, studies are planned and executed to
answer one of the two questions, but there are studies that permit both statements for internal, as well
as external, validity.
Further Research problems and areas
Beside the question of whether psychotherapeutic interventions have a cure or alleviation of disorders
with clinical relevance (effectiveness research), there are further psychotherapeutic issues that one can
focus on. These include aspects of the effect of psychotherapy (process research). It is of great
importance that you are aware and responsible for the coherence and development of psychotherapy.
Research concerning the efficacy and effectiveness of psychotherapy also include other research areas,
which include the procedural basis for research and health services research.
Validity and Limitations
The questions about the four criteria points can generally be used by all psychotherapists and
psychotherapy-methods, despite the therapy theory and therapy principles one may have.
The research strategy, which is necessary for evaluating the four criteria points of scientific
acknowledgement, is shown separately from the respective therapeutic approach and its justification.
This means, firstly, that the research projects must have as little influence on the subject whilst being
explored as possible. Repercussions of the research on the therapeutic approach should be with a wellplanned research project. If this is not ensured, the validity of the study is reduced, and this is adequately
reflected in the assessment of the study.
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I.3
Applications of Psychotherapy
The Scientific Psychotherapy Council states that the evidence of the efficacy of a psychotherapeuticprocess or method in a scope is not generally identified with the effectiveness of the entire
psychotherapeutic process/method from a different scope. In addition, the generalization of
psychotherapy-procedures/methods and efficacy in adults compared to the efficacy in children is very
limited.
From the evidence of efficacy in adults, it is not possible to conclude the same efficacy in children and
adolescents with disorders, and vice versa.
Due to this, the Scientific Psychotherapy Council decided to assess the efficacy of different
psychotherapeutic applications of adults and children separately. This does not mean that the
psychotherapeutic-procedures and their applications (diagnoses and diagnoses groups) have to be
different from one another, but assessment of the efficacy is going to be held separately.
For these concrete assessments, the Scientific Psychotherapy Council created 18 applications, in terms of
disorders, that are exclusively there for the children and adolescent psychotherapy2.
In the evaluation of psychotherapeutic-procedures, the addition of other studies with patients who do
not show a clear diagnosis from one of the 18 applications are also included (patients with complex
disorders that are represented by several ICD-diagnoses3 and/or diagnostically mixed groups of patients).
Applications of Psychotherapy in adults, children and adolescents
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
Mood Disorders (F3); including F94.1; F53
Anxiety Disorders and Obsessive-Compulsive Disorders (F40-F42; F93 and F94.0)
Somatoform Disorders and Dissociative Disorders (Conversion Disorder) (F44 – F48)
Addiction and Abuse (F1, F55)
Personality Disorder and Behavioural Problems (F6)
Adjustment and Stress Disorders (F43)
Eating Disorders (F50)
Non-Organic Sleeping Disorder (F51)
Sexual Function Disorder (F52)
Psychological and Social factors in Somatic Disorders (F54)
Schizophrenia, Schizotypal and Delusional Disorders (F2)
Organic, including symptomatic psychological disorders (F0)
Psychological and Social Factors in Mental Retardation (F7) and Developmental Disorders (F84)
Hyperkinetic Disorders (F90) and Social-Behaviour Disorders (F91, F94.2-F94.9)
Specific Developmental Disorders (F80 to F83)
Disorders of Elimination (F98.0, F98.1)
Control Disorders (F98.2)
Tic-Disorders and Stereo-types (F95 and F98.4)
The review of the criteria for the determination of scientific recognition is done separately for each
application. Psychotherapy methods are generally made to treat single disorders, so if this is the case,
2
The determination of applications were made with the consultation with the federal Joint Committee
If one study shows a diagnoses of mental disorder in accordance to the current version of the DSM-criteria, the
allocation of the application corresponding to the ICD-criteria is to be used.
3
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the determination of scientific recognition is exclusive to the treated disorder, and not for wider
application.
According to § 8 paragraph 3, in-depth training of psychological psychotherapists for child and
adolescent psychotherapy must be done in a scientifically recognized process. Since a sufficient breadth
of patient care training is required, only those procedures for in-depth training in a wide range of
application will be scientifically recognized.
II.
Procedures of assessing the scientific recognition of Psychotherapy
Methods and Procedures
The Scientific Psychotherapy Council decided, at its meeting on the 08.10.2007, the following methods
for assessing the academic acknowledgment of psychotherapeutic methods and procedures.
Assessing the academic acknowledgement takes place in five consecutive steps. On this basis, it is
recommended for a training to become a psychological psychotherapist for child and adolescent
therapist and for medical training, as a sixth step.
1.
2.
3.
4.
5.
6.
Formulating Questions
Classification as a psychotherapy process or psychotherapy method
Compilation of studies
Assessment of the various scientific studies
Establishing the scientific recognition of a psychotherapy process or method
Recommendations for training to become a psychological psychotherapist for child and
adolescent psychotherapy, as well as for medical training.
The criteria for individual assessment and judgment have been operationalized as far as possible. Their
application is nevertheless not only requires appropriate methodological skills, but also an academic
psychotherapeutic knowledge and psychotherapeutic competence. The consecutive stages of the review
process will be recorded in a report-log. This protocol begins with the start of a job evaluation in order to
influence the review process by intervening.
The individual process steps are shown below.
II.1
Classification as a psychotherapy process or psychotherapy method
In the first step of the review, the classification of psychotherapeutic methods and psychotherapeutic
procedures are distinguished.
A psychotherapeutic approach is then considered as a psychotherapy procedure when:


it is understood by its own representatives as a psychotherapy procedure,
the standard theoretical explanations of the problems and methods are made on the basis of
shared assumptions,
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


reasonable criteria for the indication, as well as approaches for individual treatment planning
and design are formulated,
the psychotherapy procedure, or method, for treating disorders of a wide range of applications
are used,
the psychotherapy procedure has been taught through in-depth training or further education.
A psychotherapeutic approach is only then considered as an individual psychotherapy method when:





it is understood by its own representatives as a psychotherapy method,
its description includes information on how to submit data for the effect to be achieved by
others, and the indication criteria,
a theoretical explanation of the origin, and the maintenance of the treatable disorder(s), are
formulated,
the specific method factors relevant to psychotherapy and other methods of psychotherapy are
different,
the method of psychotherapy was not considered as a method of an already assessed
psychotherapy procedure.
The evaluation of psychotherapy methods can also consider studies in which techniques were applied
that were also used for other psychotherapy procedures.
II.2
Compilation of Studies
The identification of the studies that form the basis of the evaluation of scientific acknowledgement
occurs in the context of a systematic literature search in relevant databases. The Scientific
Psychotherapy Council may use a third party for help if needed. The applicant, and other members, of
the psychotherapeutic method/procedure can supplement their own literature.
The search strategy for the identification of relevant studies is proposed by the representatives of the
psychotherapeutic method/procedure, and this will be reviewed by the Scientific Psychotherapy Council,
and where appropriate, modify it.
The results of the literature research will be published on the website of the Scientific Psychotherapy
Council, and the applicant will be informed in written form. The reference list may, within four weeks
after the publication on the website, elaborated if information is needed to be added.
After the expiry of the four-week period, the Council checks whether the documents produced
supplement the relevant trail basis. Should the results of the findings of the literature search need
revision, the Council has revised further search strategies. The literature list is the supplemented on the
basis of the results of the systematic literature search using the amended search strategy.
Applicants, who have applied for the examination of the scientific recognition of a psychotherapy
procedure, or method, will be called on to submit a paper within six weeks. This has to include three
copies of the publications listed in the basic list in full text. If the individual studies are not submitted,
this has to be appropriately justified by the applicant or the concerned professional group.
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The concrete steps of the systematic literature search, the screening process including the definitions of
screening criteria, and the results of the systematic research with the first screening must be
documented in a report log.
II.3
Assessment of the Individual Trials, concerning the Efficacy of
Psychotherapeutic Methods and Procedures.
Basis for assessing the effectiveness of psychotherapeutic procedures and methods are empirical
studies. The assessment of the studies includes:
1.
2.
3.
4.
5.
Determining the subject of the inquiry: The study-examined psychotherapeutic approach and
therapeutic area.
General methodological assessment
Assessment of the internal validity
Assessment of the external validity
Evaluation of the investigated results
II.3.1 Determining the Subject of Inquiry
The psychotherapeutic approach is concretized by a manual, or manual-like treatment guidelines. If a
concrete description of the procedure is lacking, and only the general psychological interventions are
indicated, then the assessment and evaluation of the methodology is considered as a clinical practice.
The revised indication area is characterized by features of the patients who were studied. This primarily
concerns the diagnoses as defined in the DSM or ICD index.
Studies where most patients have complex disorders, which are represented by multiple ICD diagnoses,
so that not clear assignment can be made under section I.3 to one of the 18 applications of
psychotherapy, must also be assessed. Such studies can optionally be included in the recommendations
for the training of psychotherapists of children and adolescents.
II.3.2 Assessment of the general Methodological Quality of a Study
The methodological quality of each study is based on the “list of criteria of quality psychotherapy studies,
Part A: Criteria for evaluating the general methodological quality assessment.” In general, studies with
sufficient overall methodological qualities are identified as:
1.
2.
3.
4.
If the criteria A1 (manipulation) and A2 (diagnosis) and A8 (measurement endpoints) were
evaluated with either a 1 or 2,
If the criterion B12 (representation of the outcome measures) were evaluated with a 1 or 2,
If the criteria C1 (clinical sample) and C9 (outcome measurement) is evaluated with a 1 or 2,
And if the average of all A-Criteria (A1 – A19) is less than 2.25.
A study will be excluded as evidence of efficacy if no sufficient methodological quality was found.
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II.3.3 Assessment of the Internal Validity of a Study
The internal validity of each study is based on the “list of criteria of quality psychotherapy studies, Part B:
Criteria for assessing the internal validity”. In general, studies with sufficient internal validity will be
determined by:
1.
2.
when adequate overall methodological quality was detected,
and if (A) the criterion B8 (group assignment) was evaluated with a 1 or a 2, and
(B) the average grade of all the B-Criteria (B1 – B12) is less than 2.25.
II.3.4 Assessment of the External Validity of a Study
The external validity of each study is based on the “list of criteria of quality psychotherapy studies, Part
C: Criteria for assessing the external validity”. In general, studies with sufficient external validity are
determined by:
1.
2.
3.
when adequate overall methodological quality was detected,
when the criteria C1 – C9 reached an average evaluation of no more than 2.25
when the criteria C10 – C13 reached an average evaluation of no more than 2.25.
II.3.5 Evaluation of the Study
A study can be regarded as one of the required evidence of efficacy: (I) if the overall methodological
quality of the study was judged to be adequate, (II) if sufficient internal and external validity was found,
and (III) if the results of the study either show:
1.
2.
3.
4.
the intervention group shows a significant outcome measures between pre-and post treatment
which are greater than in the untreated control group, the placebo-control group or the control
group “treatment as usual”
the intervention group shows an equal outcome results between pre-and post treatment
compared with an already proven effective treatment, provided the criterion A17 (statistical
power of comparison) is evaluated with either a 1 or 2
the treatment goal or a cure or improvement in the intervention group shows significant
improvement in their problems than those in the control groups, or at least as well as those in a
group with an already proven effective treatment, proved the criterion A17 is evaluated with a 1
or 2
If there is no control group present for comparisons, the results can be considered as evidence of
efficacy is the treatment effect demonstrated significant pre-and post treatment changes that
are clinically important.
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II.3.6 Consideration of Single-Case Studies
Experimental case studies can be used to assess the effectiveness of psychotherapeutic methods and
procedures if they demonstrate a systematic link between the intervention and effect, and if the general
scientific criteria are met. A systematic relationship can be identified when:
1.
2.
3.
4.
Continuous measurements of the focus related behavior / experience on all relevant study
sections are made,
a sufficient baseline of the target behavior and experience is shown,
The dependent variable is sufficiently stable within the respectively defined study,
The therapeutic approach (the intervention) is described in detail (for example using a treatment
manual).
A further condition for the consideration of single case studies is that the data is given from at least two
independent research groups/organizations/institutions.
The assessment of the studies is done on the basis of the “list of criteria to assess quality psychotherapy
studies”.
II.3.7 Focus on Older Studies
The Scientific Psychotherapy Council may re-evaluate an old psychotherapy-procedure if the given
methodological standards are not up-to-date. Should a study that was published before the first of
January 1990 meet minimum requirements, than it considered as valid (as per decision of the Scientific
Psychotherapy Council meeting from 08.06.2000).
5.
6.
7.
8.
9.
10.
the sample must be adequately described
There must be a clinically relevant outcome criterion determined with reliable methods
It must be called a clinically relevant indication criterion. This can be a diagnosis but can also be a
target syndrome, provided it can be plausible that the change of such an objective criterion can
be significantly changed
It must be given a control condition
It must be made comprehensible, wherein the therapeutic intervention process is made of.
Statements to the stability of treatment success are desirable.
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II.4
Scientific Recognition of Psychotherapy-Methods and Procedures
II.4.1 Scientific Recognition of Psychotherapy-Methods and Procedures for
Individual Psychotherapy Applications
To assess the scientific recognition of a psychotherapy procedure or a specific psychotherapy method for
a single application, all studies are used that have been studied under the same psychotherapeutic
approach (as described in II.3.1).
The scientific recognition of a psychotherapy procedure or method alone can be done if the following is
observed:
1.
and
2.
At least three methodological appropriate and valid studies, of which at least two of these have
to be positively assessed according to internal validity criteria of II.3.3, and at least two according
to the external validity criteria of II.3.4. One of the three studies can be replaced by at least five
experimental single case studies that meet the criteria mentioned in section II.3.6, and
demonstrates the effectiveness of the psychotherapeutic-procedure or method.
If at least one methodological adequate and valid study (corresponding to the criteria of II.3.3
and II.3.4) by which the criterion B11 (Follow-Up Measurement) was rated to be at level 1 or 2,
and showing the treatment success for at least six months after the end of the treatment.
II.4.2 Scientific Recognition of Psychotherapy Methods for the Treatment of
Eating Disorders
To assess the scientific recognition of a specific psychotherapy method for a single disorder, all studies
are used that have been studied in the same psychotherapeutic approach for this disorder.
For a psychotherapy method, the scientific recognition for a single disorder is determined by the
following:
1.
If at least two independent studies, whose general methodological quality and validity were
assessed as adequate, and the psychotherapy method is demonstrated as effective. This has to
include:
 (according to criteria II.3.3) at least one of these studies has to show adequate
internal validity, and
 (According to criteria II.3.4) at least one of these studies needs to show sufficient
external validity.
One of the two studies can be replaced by at least five experimental case-studies that meet the criteria
in section II.3.6, and the effectiveness of the psychotherapeutic-procedure or method need to be
displayed.
and
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2.
If at least one methodological adequate and valid study was completed with a study that fulfilled
the criterion B11 (follow-up measurement) at the level 1 or 2, and showing that the treatment
success for at least six months prior the treatment ending.
3.
Evidence of significant adverse effects of the psychotherapy method is available. This is usually
the case when at least 10% of the studies were considered adequate, in which at least 2 studies
have to be adequate in the general methodology, and the internal or external validity (according
to the given criteria mentioned in the previous sections)
III.
Recommendations for the Training of the Psychological Child and
Adolescents Psychotherapists
A psychotherapy procedure or method, in principle, has to be subject to an in-depth training of the child
and adolescents’ psychotherapist, or trainee. An application for recognition of a training institution
should be granted if for all areas of psychotherapy are scientifically recognized methods, at least for the
core areas of psychotherapy. These can assigned to the same, or different, psychotherapies. For an
application for the recognition of a training institute, applicants need to indicate which psychotherapy
methods will be taught for which applications, and which trainer/supervisors are available for the
training of the psychotherapy method.
III.1 Recommendations for the training to become a Psychotherapist
Only those procedures will be approved for psychotherapy that are in accordance with §1 paragraph 1 of
the training and examination regulation. The scientific recognition for the applications was as following:
The following two application areas:
1.
Affective Disorders (F3); including F94.1, F53
2.
Anxiety Disorders (F40 – F42, F93 and F94.0)
And either, in addition, at least one of the following applications:
3.
Somatoform Disorders and Dissociative Disorders (Conversion Disorders) (F44 – F48)
4.
Dependence and Abuse (F1, F55)
5.
Personality Disorders and Behavioral Disorders (F6)
Or, in addition, at least two of the following applications:
6.
Adjustment Disorders and Stress Disorders (F43)
7.
Eating Disorders (F50)
8.
Non-Organic Sleep Disorders (F51)
9.
Sexual Dysfunction (F52)
10.
Psychological and Social Factors in Somatic Disorders (F54)
11.
Schizophrenia, schizotypal and Delusional Disorders (F2)
12.
Organic, including symptomatic, Mental Disorders (F0)
13.
Psychological and Social Factors in Mental Retardation (F7) and Deep Developmental Disorders
(F84)
14.
Hyperkinetic Disorders (F90) and Conduct Disorders (F91, F94.2 – F94.9)
18.
Tic Disorders and Stereotypes (F95 and F98.4)
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Instead of the scientific recognition in the application areas 6 to 14, or in the scope 18, individual cases
can be acknowledged if the evidence of efficacy is corresponding to studies on “mixed interference” and
if these studies fulfill the criteria under point II.3.1, and II.4.
III.2 Recommendations for Training Children’s and Adolescents
Psychotherapists
Only those psychotherapies are recognized as procedures of in-depth training on children and
adolescents according to §1 paragraph 1 of the training and examination regulation for child and
adolescent psychotherapist. The scientific recognition for such has to have at least the following
applications:
In all three of the following applications:
1.
2.
14.
Affective Disorders (F3; including F94.1, F53)
Anxiety Disorders (F40 – F42, F93 and F94.0)
Hyperkinetic Disorders (F90) and Conduct Disorders (F91; F94.2 – F94.9)
Or
At least two of the following applications:
1.
Affective Disorders (F3; including F94.1, F53)
2.
Anxiety Disorders (F40 – F42, F93 and F94.0)
14.
Hyperkinetic Disorders (F90) and Conduct Disorders (F91; F94.2 – F94.9)
And additionally at least two of the following:
3.
Somatoform Disorders and Dissociative Disorders (Conversion Disorders) (F44 – F48)
4.
Dependence and Abuse (F1, F55)
5.
Personality and Behavior Disorders (F6)
6.
Adjustment Disorders and Stress Disorders (F43)
7.
Eating Disorders (F50)
8.
Non-Organic Sleep Disorders (F51)
9.
Sexual Dysfunction (F52)
10.
Psychological and Social Factors in Somatic Disorders (F54)
11.
Schizophrenia, schizotypal and Delusional Disorders (F2)
12.
Organic, including symptomatic, Mental Disorders (F0)
13.
Psychological and Social Factors in Mental Retardation (F7) and Deep Developmental Disorders
(F84)
15.
Specific Developmental Disorders (F83)
16.
Disorders of Elimination (F98.0, F98.1)
17.
Regulatory Disorders and Feeding Disorders (F98.2)
18
Tic Disorders and Stereotypes (F95 and F98.4)
Instead of the scientific recognition in the application areas 3 to 13 or 15 to 18, individual cases can be
recognized if the evidence of efficacy corresponds to the regulations in paragraph II.3.1. Psychotherapy
procedures and psychotherapy methods for a smaller number of applications, as in III.1 and III.2, cannot
be considered under the training of psychological psychotherapist for children and adolescents.
Methods Paper of the Scientific Psychotherapy Council, according to §11 PsychThG
Page 16 of 23
Attachment
1.
A
1.
Criteria for the assessment of Studying the Quality of
Psychotherapy Studies
Criteria for Assessing the General Methodological Quality
Manipulation of the Data
(level 3 = Exclusion Criterion)
2.
Patients
Objective and Reliable Diagnosis (by means of partially
standardized interview)
(Level 3 = Exclusion Criterion)
3.
Number of drop-out rates to treatment (if not successful)
4.
Number of drop-out rates to catamnesis (if catamnesis
conducted the survey)
5.
6.
7.
Study Design
Sample size per group
Comparison (if any) of the treatment groups to the
Measurement time points
Outcome Measurement
A priori definition of the primary and secondary endpoints
Operationalization
1) No indications pointing to
manipulation of results
3) Indication of manipulation of the
results
1) Diagnosis by means of structured
clinical interview (e.g. SCID, DIPS)
2) Diagnosis using diagnostic
checklists and comprehensible
clinical judgment
3) No adequate diagnosis
1) Drop out quote smaller than 20%
2) Drop out quote between 20% and
40%
3) Drop Out quote larger than 40%
1) Significantly better than in studies
with similar patient groups and
comparable follow up period
2) Drop-out rate compared with
studies with patient groups and
corresponding follow-up period
3)Significantly lower than in studies
with similar patient groups
1) n per group > 30
2) n per group 10-30
3) n per group < 10
Deviations from this scheme may
occur with very seldom disorders
1) a priori definition of the
comparison treatment group and
time points met
2) partially defining the post-hoc
comparisons
3) only post-hoc comparisons
defined
1) a priori defined primary and
possibly secondary endpoint
2) a priori criteria, provided the
target without differentiation in
primary and secondary outcome
measures
3) a posterior definition of objective
criteria, no information on
Methods Paper of the Scientific Psychotherapy Council, according to §11 PsychThG
Page 17 of 23
8.
Reliably and valid measurements of at least the primary
outcome measures
(Level 3 = Exclusion Criterion)
9.
Clinical Significance of the Outcome Measurement
10.
Multiple Information sources (e.g. patient, therapist, lab
results)
11.
External assessment procedures: external evaluators
12.
Complete presentation of the results on all outcome
measures, and to all relevant measurement time points
13.
Detection of adverse effects
14.
Statistical Methods
Requirements application for statistical models tested and
met
outcomes
1) Reliable and Valid outcome
procedures
2) Only limited reliability and/or
validity of the measurement process
3) Reliability and validity of the
measurement method does not
validate criteria for the test method
1) Clinical significance of the
therapeutic effect is detectable
2) Clinical significance of the
therapeutic effect is only partially
detectable
3) Clinical significance of the
therapeutic effect is not detectable
1) Multidimensional assessments of
objective criteria – three of more
sources of information
2) two sources of information
3) one source of information
1) Validated external assessment
procedures applied by trained,
external conditions for the groupblind raters
2) Validated external assessment
procedures applied by trained, nonblind external evaluators
3) Foreign validated assessment
method used.
1) Reported about all outcome
variables
2) Reported only for the primary
outcome measures
3) not reported for all primary
outcome measures
1) Systematic collection and
reporting of adverse events, side
effects, deterioration
2) Unsystematic collection and/or
incomplete reporting of undesired
outcomes
3) Adverse events, side effects ,
deterioration were detected and not
reported
1) Application requirements tested
and completed
2) Usage conditions tested and no
examination of the conditions
3) Significant violations of the
conditions for applying or no review
of the application requirements.
Methods Paper of the Scientific Psychotherapy Council, according to §11 PsychThG
Page 18 of 23
15.
Adequacy of statistical analysis (including the correction for
multiple tests)
16.
Intention to Treat – analysis performed
17.
Statistical power of comparison in comparison to the proven
treatment group
18.
Complete description of the Drop-Outs
19.
Drop-Out-Analysis
1) Adequate and comprehensive
analysis
2) Largely adequate statistical
analysis
3) Inadequate statistical analysis
1) ITT analysis performed
2) No ITT analysis at low risk of
attrition bias
3) No ITT analysis at distinct risk of
attrition bias
1) Adequate statistical power of
comparison
2) Limited power of statistical
comparison (.50 - .80)
3) Inadequate statistical power of
comparison (<.50)
1) Complete description of all dropouts, including the reasons and the
time of drop-out
2) Incomplete data on causes of
drop-outs
3) A description of drop-outs or
definitive indication of the number
of drop-outs is given
1) Drop-out analysis has no
significant differences between the
comparison group
2) Drop-out analysis has show
difference in the validity of the
results and are not substantially
impaired
3) Drop-out analysis is not carried
out or ignores relevant prognostic
characteristics
Methods Paper of the Scientific Psychotherapy Council, according to §11 PsychThG
Page 19 of 23
B.
1.
2.
Criteria for assessing the internal validity
Patients
Specification of inclusion and exclusion criteria
Collection of the specified inclusion and exclusion criteria
by validated methods
3.
Interventions
Operational definition of the interventions
4.
Operational definition of the controlled conditions
5.
Structural equivalence of the controlled conditions
6.
Treatment Integrity
Operationlization
1) Clear specification of inclusion
and exclusion criteria
2) Inclusion or exclusion criteria
described
3) inclusion and exclusion criteria
are not defined
1) The inclusion and exclusion
criteria are all clear and
operationalized by obtainable valid
methods
2) The validity of the inclusion or
exclusion criteria is partially
impaired
3) The validity of the inclusion or
exclusion criteria is clearly limited
and has a differential effect on the
composition of the treatment group
1) Therapy manual is comparable
and replicable
2) description of therapy, without
further specification of the
intervention
3) The intervention is not described
clearly to the designation of the
psychotherapy process.
1) Prospective identification and
extensive description of the control
conditions
2) Ex-post facto description of the
control conditions
3) No description of the control
conditions
1) The therapeutic care and the
setting conditions are equivalent to
the Control Group
2) The level of therapeutic care and
the setting conditions differ from
the CG
3) The level of therapeutic care in
the CG is significantly reduced and
the setting conditions differ from
that of the Intervention Group.
1) Manual loyalty / integrity
treatment by external observers (for
example, video based)
2) Manual loyalty / treatment
Methods Paper of the Scientific Psychotherapy Council, according to §11 PsychThG
Page 20 of 23
7.
8.
Eligibility, documentation and analysis of the influence of
accompanying non-randomized interventions
Study Design
Group membership
(Mandatory criterion for internal validity - <3 )
9.
Comparability of groups at baseline in terms of prognosisrelated features
10.
Definition of the measurement time points
11.
Follow-Up measurement
12.
Outcome Measurements
Amount of changes on the primary and secondary
outcome measures compared to the control group
(Level 3 = Exclusion Criterion)
integrity demonstrated by
questionnaires
3) No measures to monitor the
fidelity or references to the manual.
1) Exclusion of an accompanying
non-randomized intervention
2) Accompanied, non-randomized
interventions are permitted
3) Accompanied, non-randomized
interventions are permitted
1) Adequate randomization at
sufficient sample size n>30/group
2) Parallel or partially randomized,
or quasi-randomized, sample size
n<30/group
3) no randomized group
1) Neither statistically nor clinically
relevant differences between the
groups in terms of relevant
prognostic variables
2) Comparability with regard to
most relevant prognostic features is
largely valid
3) Lack of adequate review of the
comparability and comparison.
1) Several pre-defined times of
measurement, over the course of
the therapy, including pre-post
measurements
2) Only pre-post measurements
3) Only post-measurements
1)A high sample of adequate
catamnsis
2) A low utilization of the sample
and a reasonable catamnesis
3) No catamnesis
1) Full details of the changes
achieved on the target criteria,
including the significance, size and
extent of the effect measured
2) Presentation of the treatment
results only by changing dimensions
or achievements, or both
3) Very incomplete or inadequate
representation of the outcome
criteria
Methods Paper of the Scientific Psychotherapy Council, according to §11 PsychThG
Page 21 of 23
C.
1.
Criteria Assessing the External Validity
Patients
Sample of patients with symptoms and disorders
(Level 3 = exclusion criterion)
2.
Method of recruiting the samples
3.
Selection of the samples, due to the exclusion criteria
4.
Intervention
Clinical representativeness of the intervention in terms of
approach and duration
5.
Method of the Therapy-Monitoring
6.
Admissibility of accompanying interventions (e.g.
pharmacotherapy)
7.
Qualifications of the practitioner
a) Clinical activity of the therapist
Operationalization
1) Only patients with a disorder
from the ICD or DSM manuals
2) Sample of patients with probable
clinical disorders
3) Patients without any problems
are detected with clinical disorders
1) Access of patients mostly through
clinical routine; no selection effects
due to access routes
2) Access of patient mostly through
clinical routines
3) Access of Patients mainly through
calls to the researcher group (e.g.
advertising)
1) No selection effects due to the
exclusion criteria: Inclusion of all
patients
2) Medium selection effects due to
the exclusion criteria
3) Significant selection effects due
to the exclusion criteria
1) Intervention in everyday clinical
practice
2) Intervention with respect to
clinical practice sometimes changed
daily
3) Intervention compared to clinical
practice of everyday life, changed
dramatically
1) No change in behavior by the
therapist therapy monitoring
2) Average change in behavior
through therapist therapy
monitoring
3) Major change in behavior by the
therapist therapy monitoring
1) No restrictions
2) Accompanying in usual routine
interventions partly excluded
3) All associated routine practice
interventio0ns are excluded
1) Therapist is practicing as a
clinician
2) Clinical researcher, mainly
engaged in research and less in
Methods Paper of the Scientific Psychotherapy Council, according to §11 PsychThG
Page 22 of 23
b) Width of the clinical activity of the therapist
c) Specific training of the psychotherapist in a treatment
method for the study
8.
Study Design
Representativeness of the patient freedom in the choice
of intervention
9.
Outcome Measurements
Primary outcome measures related to patient-relevant
parameters
(Level 3 = exclusion criterion)
10.
Practice Transfer
Specification and manufacture of necessary Setting
Conditions
11.
Specification and manufacture of necessary treatment
skills
12.
Specification and understandability of relevant patient
characteristics
patient treatment; education
candidate
3) Not a clinician, or a clinician who
is not a psychotherapist
1) Therapist treats patients with
various problems within and outside
the study
2) Therapist treats patients with
similar problems
3) Therapist only treats patients
with similar problems within and
outside the study
1) No specific training for the study
2) short training for the study or
intensive training for a few
therapists
3) Intensive training before the
study
1) Patients choose for themselves
one of the available therapies
2) A proportion of patients is
randomly assigned to a certain
treatment
3) All patients are randomly
assigned for a certain treatment
1) The objective criteria are based
on several dimensions of patients,
or fault-related parameters
2) Objective criteria relate only to
one dimension
3) The objective criteria are based
solely on surrogate parameters
1) Necessary setting conditions are
produced (such as infra-structure,
cooperation team, etc)
2) Necessary setting conditions are
produced only partially
3) Necessary setting conditions are
not produced
1) Necessary treatment skills are
clearly identified and produced
2) Necessary treatment skills are
clearly identified, but only very
time-consuming to produce
3) Necessary treatment skills are not
described or not practical to
produce
1) Relevant patient characteristics
(such as age, genetic markers) are
Methods Paper of the Scientific Psychotherapy Council, according to §11 PsychThG
Page 23 of 23
13.
Specification and understandability of relevant treatment
aspects
detected
2) Relevant patient characteristics
detected only with considerable
effort
3) Relevant patient characteristics
not identified
1) Relevant treatment
characteristics (type of
interventions, order, duration) are
practically produced (e.g. manual)
2) Relevant treatment
characteristics are difficult to
manufacture
3) Relevant treatment
characteristics are not practical to
produce
2.
Application of Psychotherapy in Adults, as well as in Children and
Adolescents
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
Mood Disorders (F3); including F94.1; F53
Anxiety Disorders and Obsessive-Compulsive Disorders (F40-F42; F93 and F94.0)
Somatoform Disorders and Dissociative Disorders (Conversion Disorder) (F44 – F48)
Addiction and Abuse (F1, F55)
Personality Disorder and Behavioural Problems (F6)
Adjustment and Stress Disorders (F43)
Eating Disorders (F50)
Non-Organic Sleeping Disorder (F51)
Sexual Function Disorder (F52)
Psychological and Social factors in Somatic Disorders (F54)
Schizophrenia, Schizotypal and Delusional Disorders (F2)
Organic, including symptomatic psychological disorders (F0)
Psychological and Social Factors in Mental Retardation (F7) and Developmental Disorders (F84)
Hyperkinetic Disorders (F90) and Social-Behaviour Disorders (F91, F94.2-F94.9)
Specific Developmental Disorders (F80 to F83)
Disorders of Elimination (F98.0, F98.1)
Control Disorders (F98.2)
Tic-Disorders and Stereo-types (F95 and F98.4)