PSYCHOTHERAPEUTIC TREATMENT OF EATING DISORDERS

Objetivo

1.Background

Anorexia nervosa and bulimia nervosa are serious psychological disorders occurring principally in adolescent females and young women. Both illnesses are relatively common and up to the 1990s have been on the increase. Statistical analyses of case registers at psychiatric and general medical clinics have shown admission rates for eating disorders for the United Kingdom, Denmark, Switzerland, the Netherlands and Czechoslovakia of approx. 5 per 100 000 inhabitants. Investigations into non-clinical risk populations - usually schoolgirls and women students - estimate a frequency up to 10% for bulimia nervosa (a life-time risk of 2,8% under strict diagnostic criteria) and approx. 1% for anorexia nervosa.

The frequency (estimations of incidence rate have shown figures up to 26,3/100 000 in women between the ages of 10 and 19/Rochester Study) and seriousness of the illnesses (the mortality rate for anorexia nervosa is estimated at up to 20% - in a 20-year follow-up) reveal the particular relevance of the proposed research project.

The illness frequently becomes chronic with serious bodily, psychological and social effects. Treatment of such patients, whether in the acute phase or intermittently during a chronic course, involves considerable time and effort and is not always successful. The state and course of the two illnesses, as well as the prognosis and results of psychotherapeutic treatments, are determined by a multiplicity of factors. There is broad agreement that:

1)the nature, seriousness and duration of the symptoms
2)family and social factors
3)biological and endocrinological parameters
4)personality factors play an important role. However, little is known at present about whether, and if so how, these factors interact and in what way they influence the result of the treatment or the long-term course of the illness. The samples available so far are generally far too small on account of the large number of potential prognosis factors and the complex interaction between them.

Psychotherapy is helpful to many patients. Nevertheless, in the long term, only 40 to 50% of those treated can be regarded as cured. Psychotherapy, whether in-patient or out-patient, is a well established form of treatment for these patients and has been a part of everyday clinical practice for years. The therapy is carried out with varying degrees of intensity and for varying periods of time, depending on the local organizational conditions and clinical preferences. For seriously ill patients complex - in-patient and out-patient - therapy programmes are used. So far, however, the complex make-up of the various components of the therapy has only rarely been taken as the explicit subject of empirical research; often it is not even carefully documented. Systematic empirical knowledge is correspondingly scarce.

A "myth of uniformity" continues to pervade the majority of empirical studies. A systematic description of the inter-individual differences between the therapies applied is practically never given. Instead, there are usually only blanket terms such as "cognitive behavioural therapy" or "psycho-dynamic therapy". One of the central problems of the therapy service system, namely the distribution of scarce and expensive therapy resources, has remained almost unnoticed so far. There are at the moment only very few empirical results regarding one of the key problems of treatment planning i.e. choosing the frequency of therapy sessions and the length of treatment which will have the greatest impact on the most important therapeutic aims, for the minimum cost.

The current state of the art can be characterized by four crucial areas in which our knowledge is deficient, thus implicitly formulating the key topics for medium-term research in this area:

1)Although psychotherapy is found to be of benefit to many patients, there is still very little known about the differential predictors of the success of the therapy.

2)Imprecise definition and inadequate documentation of the therapy (programmes) which were actually carried out reduces the value of therapy studies.

3)Insufficient attention is given to the multidimensional nature of changes, in particular the criteria for success. The concept of clinical significance developed for general psychotherapy research is still widely unknown.

4)Finally, little is known about how, once it has been achieved, an improvement in symptoms can be stabilized in the long term.

In conclusion, one can state that, mainly because of the small samples used in most studies, the question "who benefits most from what psychotherapy programme" is still unanswered.
The proposed research action is focused on the main and the secondary exploratory questions characteristic for a phase IV study. The research strategy centres on field or observational studies; the statistical methodology is chiefly one of a prognosis study. Therefore very large samples are needed.

Precisely in psychotherapy, the choice, extent and duration of treatment are regarded (subject to certain framework conditions) as matters to be agreed between patient and therapist; often such agreement is only reached, or even modified, during the treatment, depending on how it is going and on the individual preferences, wishes or capabilities of patient or therapist. In order to find out more about how patients actually demand treatment or how therapists actually apply it, there must be as little interference as possible in therapeutic routine; it will generally be necessary to forego any standardization of treatment, experimental controls on certain variables or randomization.

Grounds for carrying out the research project in the framework of COST co-operation

-Anorexia nervosa and bulimia nervosa are illnesses affecting principally adolescent females and young women. In all Western (industrial) countries - and, following the opening up of Central and Eastern Europe, increasingly in those countries too - these illnesses are among the most prevalent psychological disorders. It is thought that cultural and social factors strongly influence the onset and course of the illnesses. Comparative international studies to clarify such questions are lacking. The tremendous social changes in the States of Eastern Europe and co-operation with researchers and institutes in these countries offer an excellent opportunity to clarify these influences.

-In nearly all European countries, patients with eating disorders are treated frequently by psychotherapy. Depending on the particular medical care system involved, various therapy programmes - in-patient or out-patient - are applied, and so experience with these various programmes of therapy, obtained under everyday clinical conditions, is available. Scientific analysis and co-ordinated exchange of information promise major insights for the planning of efficient treatments.

-In all developed countries, health services are facing severe economic problems. Questions regarding the epidemiology of care are therefore of great importance. Questions concerning patients' demand behaviour (who receives therapy, how much and by what route?) and therapists' application behaviour (who offers therapy to whom, how much and subject to what conditions?) can be looked into using the example of sufferers from eating disorders. Through international comparison, not only individual assumptions by the patient or therapist, but also the structural conditions of the various health services can be taken into account.

Benefits of the proposed research action

The proposed research action is designed to improve the psychotherapeutic care of patients with anorexia nervosa and bulimia nervosa, with special reference to questions of health economics and epidemiology of care. These questions are of enormous topical interest for all European countries.
Standardized investigation into effectiveness and efficiency will allow the exchange of clinical experience gathered under different social and structural conditions. This increases the potential for learning new information and facilitates Europe-wide co-ordination of new developments or alignment of tried and tested models.

The investigation of factors giving a favourable or unfavourable prognosis for the course of the illness and determining whether it is treatable will create empirical bases for (a) targeted preventive measures against the development of chronicity and relapse and (b) a more efficient allocation of therapeutic resources on the basis of improved differential indication.

The research action promises progress towards affordable, high-quality treatment for an important group of patients. The anticipated results can be taken as an example, and used for other groups of patients.

The co-ordinated research action does not overlap with other co-operation programmes of the EU. An exchange with the project "psychotherapy in Europe" within the frame of BIOMEDICAL AND HEALTH RESEARCH PROGRAMME DG XII-E-4 could be of interest.

The research action will give scientists from Eastern and Southern European countries in particular the opportunity for increased co-operation with research groups in Western and Northern Europe. In this way it will be easier for them to find their own ways into a research field which is in part still new for them.
The European Council for Eating Disorders (ECED) is an informal organization for clinicians who are engaged in the treatment of eating disordered patients. Therefore, the ECED represents a good opportunity to connect the research activity as that proposed by this action with broader activity in the field. ECED can be a good host for continuing co-operation.

2.Objectives of the action

2.1Main aims

The main aims of the research action are as follows:

2.1.1to assess the effectiveness/success rate (in relation to symptoms, personality development and social and family integration) of psychotherapeutic treatment programmes in patients with anorexia and/or bulimia nervosa according to DSM III R/IV (evaluation)

2.1.2to assess the relationship between therapeutic effort and the success of the therapy (health economics)

2.1.3to identify factors yielding a favourable prognosis for the treatment (systematic treatment selection)

2.1.4to investigate the long-term course of the illnesses or of the recovery, and identify risk factors for recurrence and relapse (prevention against recurrence and relapse)
2.2Secondary objectives

The secondary questions are chiefly concerned with epidemiological aspects of care:

2.2.1How much therapy is received, and by whom?

2.2.2What conditions determine the supply of therapy?

(a) characteristics or predisposition of patients

(b)characteristics of the system of psychotherapeutic care

(c)by what routes do patients with eating disorders obtain therapy?
what makes access easier, what makes it more difficult?

2.2.3How much therapy is actually demanded?

2.2.4What are the factors determining how much therapy is given?

2.2.5How is access to therapy affected by the disease becoming chronic?

3.Scientific content of the action

The work programme comprises the following steps:
3.1Standardizing investigative instruments;

A great variety of instruments are used, some of them specific, others non-specific, for eating disorders. The choice depends often on local/national traditions or theoretical orientations. The availability presents the problem of translation, since many of them are questionnaires or inventories.

The choice of instruments, their adjustment to the national/local conditions, in some cases their translation, will be the dominating activities during the first phase of the action. The study protocol of the German Multicentre Study forms the starting point therefor.

3.2Standardizing investigative procedures;

The investigation of efficacy and efficiency of psychotherapy programmes requires

1)a synchronized time schedule for data collection (begin and end of the treatment, follow-up, intermediate assessments),

2)a precise agreement on the procedure for data collections. Thus, for example, interviews have a key position for the clinical description of patient's state and change. Therefore standardization of interview techniques is indispensable. A video-manual was developed for the German Multicentre Study and is available for the necessary training,
3)measuring of therapy effort. This is "new land" in psychotherapy research. It has to be decided consensually what has to be counted as therapy effort. A particular measurement problem is presented by "indirect treatment activities", e.g. diagnoses conferences, team meeting for treatment planning, internal and external supervision etc. This "indirect treatment activities" can accumulate - especially in the case of inpatient treatment - to a considerable proportion of the total amount of therapy.

3.3Standardizing data storage and handling

For exchanging data between different national research teams an agreement on the storage and handling of data is required. For that, the hard- and software have to be adjusted in the initial phase.

3.4.Operationalizing therapy outcome

-multidimensional: choice of criteria, respectively, dimensions of change, definition of change patterns,

-multiperspectival: assessment from the perspective of patients and therapists or clinical experts separately,

-clinically meaningful: adaptation of the concept "clinical significance" to the chosen dimensions.

3.5.Data collection

3.6.Development of mathematical models for the relation between therapy effort and outcome:

Logistic Regression Models, Classification and Regression Tree-Structures as well as Survival and Reliability Models are modern statistics, whose adequacy for the main questions of this project has to be tested.

3.7.Standardizing the data analysis

In this action, dataset will be of such complexity and size that the common commercial statistical packages are insufficient. The development and exchange of routines and subroutines for preparing data for statistical analysis will therefore have to be co-ordinated.

3.8.Comparison of national research results - final report

4.Timetable

The timetable is scheduled on 7 phases. An intermediate evaluation will be performed after the fourth phase. The continuation of the action will be decided depending on the tasks accomplished until that time.

Phase 1:standardization of instruments and methods,
standardization of data storage

Phase 2:data collection at the beginning and end of treatment,
operationalization of treatment outcome
Phase 3:choosing and testing mathematical models,
preparation of data for statistical analysis

Phase 4:data analysis: pre- and post comparison

Intermediate evaluation

Phase 5:follow-up data collection

Phase 6:follow-up data analysis

Phase 7:comparison of national research results,
final report.

5.Organization management and responsibilities

A Management Committee will be set up following signing by the appropriate number of signatories to the Memorandum of Understanding. A Chairman/woman will be elected and entrusted with drafting an outline project plan based upon the work programme described in 3 above. This plan will then be worked out by the Management Committee.

The Management Committee will report yearly in verbal or written form. It will meet twice a year, at least once in Brussels. Methodological and instrumental premises have to be created particularly during the first phases. Consensus conferences and training sessions will have to be organized. For this reason during the first two years two workshops a year will be needed. In the following years the scientific activities will be supported by one workshop and one seminar per year. The results of the whole research action will be summarized in a final report.
In order to carry out this programme, suitable communication structures (e.g. electronic mail, mail box) will need to be established and maintained. In addition, there should be regular meetings giving the opportunity for an informal exchange of information between the individual research fellows or research groups. To this end, lengthy research stays by experts at certain centres are considered highly desirable, in order to tackle any specific mutual problems together.

6.Economic dimension of the project

The study in the proposer state (Germany) alone is estimated to cover 70 person-years (6 full-time research fellows per year and two technical employees; in addition 5 part-time research fellows and more than 50 therapists for study-specific diagnosis) over 6 years. The major scientific expenditure involved will be borne by the Federal Ministry of Research and Technology. Some of those research groups that have already declared their interest in the proposed research project can already estimate the amount of their contribution as follows:

United Kingdom: 18 person-years (shared by several people)

Austria 7 person-years (shared by several people)

Sweden12 person-years (shared by approx. 10 people)

Czech Republic12 person-years (shared by several people)

Hungary15 person-years (shared by several people)
Taking into account that research groups from approximately 12 countries will take part in the action and that they will invest comparable scientific resources (i.e. average 2 research experts per year) a resulting figure of approximately 200 person-years, that is ECU 12 million, has to be foreseen.

Investment of ECU 6 000 per year is expected for equipment and material (travel expenses for patients, soft- and hardware, printing costs for questionnaires and licences). Apart from this, a total of approximately ECU 300 000 will be needed for the German study over the time of the research action.

The costs for co-ordination work cannot be estimated at this point. However, if one takes ECU 60 000 per year as an approximate figure, the total sum to be expected for the six-year duration of the action amounts to ECU 360 000.

The total expenses for the proposed COST action therefore are estimated at ECU 13 million.

Current status
Working Groups
WG 1 : Standardisation of Measuring Instruments and Procedures
Deepening and Enriching the Core Battery of Instruments
Assessment Instrument for the first Follow-up
Training in the Administration of the EAT-SADS and LIFE-EAT II
WG 2 : Genetics of Eating Disorders - (finished)
WG 3 : Psychotherapeutic Treatment of Eating Disorders in Children and Adolescents
WG 4 : Measuring Therapeutic outcome in Action B6
WG 5 : Monitoring, Evaluating, Steering : Quality Management for Psychotherapeutic Services for Eating Disorders
WG 6 : Mathematical Models of the Course of Recovery for Eating Disorders
Short Term Scientific Missions
6 Short Term Scientific Missions were approved and completed before the end of 1996.
Study contract
"Development of a Data Management System.".
Work planned
The Action agreed on the core battery of tests for the assessments and a standard for the data management worked. In most of the participating countries data collection has already been started.
According to the work and timeplan of the Action, data collection will be continued during the next period. At the end of 1998 data on the treatment phase for the whole sample will be available. In 1997 the one-year follow-up investigation will start, the 18-month follow-up will be prepared.
The increasing data set is enabling the Action to set up the mathematical modelling procedures. In parallel, the Action is preparing for the utilisation of the aimed-for results. The Working Group on "Quality Management for Psychotherapeutic Services for Eating Disorders" will work out a monitoring system, into which the empirical findings on effectiveness can be integrated. The mathematical models of the course of recovery will provide a rationale for the development of steering procedures which are sought to improve the cost-effectiveness of therapeutic services.
Two scientific workshops are planned to relate Action B6 research to other work in the field and to ensure that the findings and developments of the Action are brought to the notice of the scientific community.

Programa(s)

IC-COST - European cooperation in the field of scientific and technical research (COST), 1971-

Tema(s)

7 - Medical Research

Convocatoria de propuestas

Data not available

Régimen de financiación

Data not available

Coordinador

CEC

Aportación de la UE

Sin datos

Dirección

Rue de la Loi 200
1049 Brussels
Bélgica

Coste total