Excerpt of the presentation

Deployment and clinical evaluation of a Web-based self-help guide for the treatment of Bulimia Nervosa

Tony Lam 1, Isabelle Carrard 2, Patrick Rouget 2, Thierry Raguin 1, Mickael Cappozzo 1
1 NetUnion SARL, 2 Hopitaux Universitaires de Geneve, Switzerland

Eating disorders are a common source of psychiatric morbidity among young women [1]. In order to respond to such problems, it is urgent to develop and evaluate more accessible treatment methods. Self-help manuals are one solution. Research on self-help manuals for the treatment of Bulimia Nervosa (BN) has already been conducted in Anglo-Saxon countries, where effectiveness of such methods is recognised [2, 3, 4, 5, 6, 7]. These manuals are based on cognitive and behavioural therapy (CBT) and provide step-by-step methods to face eating disorders by progressively recovering self-control over one's food behaviour. Self-help manuals offer an innovative solution for meeting the increasing demand for specialised treatment. However, patients working alone with these manuals need to be strongly motivated to succeed. The added work of recording, and organising daily records could also be an obstacle to success.

Using online versions of these self-help manuals could bring new benefits [8]. Online systems allow patients to submit exercise directly thus limiting the amount of paperwork for both the patient and the health care provider. Therapists can monitor and track their patient's progress easily, and the system could provide more flexible channels of contact with the patient. Web-based applications can also reach people that otherwise would not seek help, due to practical or constraints such as physical distances, psychological constraints, or a sense of shame (BN is most of the time linked with shame) [9].

The goal of this study is to increase research evidence of the advantage of using online self-help manuals [8]. Our main hypothesis is that the online delivery of self-help manuals can be effective for the treatment of BN. The study also seeks to determine clinical predictors for treatment outcome from the collected data.

The study is part of Salut! (IST-2000-25026), a 39-month project funded by the European Commission under the 5th Framework Programme and by the Swiss Federal Office for Education and Science (OFES). This project, started in January 2001, aims at developing Web-based and mobile tools for diagnosis, treatment, and prevention of eating disorders. The online Self-Help Guide (SHG) for outpatient treatment of BN is one of the main results of this project. Clinical trial activities for the evaluation of the SHG started in October 2002 and will continue until January 2004. Trials are conducted in Switzerland, France, Spain, and Sweden in French, Spanish, and Swedish. The multi-lingual platform of the SHG enabled the project to rapidly deploy multiple versions of the SHG, facilitating the extension of research and trial activities to other countries.

The SHG has been designed to deliver evaluation and treatment modules allowing users to recover from their eating disorder. Effectiveness of self-help manuals based on CBT has already been shown and the goal of this study is to increase research evidence of the advantage of using online self-help manuals.

Our main hypothesis is that the online delivery of self-help manuals can be effective for the treatment of BN. A secondary objective is to determine predictors of treatment outcome based on analysis of positive treatment outcome and patient population. The study will also try to ascertain the attractiveness of an online self-help treatment to patients, the potential for reducing treatment cost, and for filling unmet demands in the patient population.

Study design
Clinical trials have a six-month cycle, including four months self-treatment and two months follow-up. Patients suffering from BN are evaluated three times: before the self-treatment, after the self-treatment (four months later) and after the follow-up (6 months after first evaluation) with standardised questionnaires (EDI-2 [10], SCL-90R [11]) and an anamnestic questionnaire (QATA). Evaluation sessions are conducted in face-to-face meetings.

During the self-treatment period, all trial participants maintain weekly e-mail contact with their assigned "coach". Coaches conduct the evaluation sessions, answer questions about usage of the guide and provide some encouragements. Coaches can monitor progress of their own patients via the result analysis module of the SHG and recommend other treatment as necessary. Control groups (waiting-list or psycho-educational therapy) are included on a country-by-country basis.

Participants are recruited through each trial centre according to the following inclusion and exclusion criteria:

Inclusion criteria:
" Women with BN
" Purging type with self-induced vomiting (according to DSM-IV [12])
" Aged from 18 to 30 (participants older than 30 are accepted if duration of bulimia is less than 10 years)
" Body mass index > 17.5

Exclusion criteria:
" Ongoing CBT
" Severe depression
" Drug addiction or alcoholism
" Recent (less than 2 years) and repetitive (more than 2 in a year) suicide attempts

The online version of the SHG was developed by the liaison psychiatry unit of the University Hospitals of Geneva and by NetUnion in Lausanne. The SHG (http://www2.salut-ed.org) is based on CBT and is composed of seven sequential steps: (1) preparing yourself for change, (2) observing yourself, (3) changing your behaviour, (4) changing the way you think, (5) identify and solve your problems, (6) self-assertion, and (7) conclusion.

A set of questionnaires (EDI-2, SCL-90R and QATA) will be used to evaluate treatment effectiveness, attractiveness of the online treatment tool, and user satisfaction. Data collected during the study will be analysed using the statistics package Software for Statistics in Social Sciences (SPSS) to answer questions about effectiveness and to search for possible predictors of treatment outcome.

A priority in the study is to protect the confidential relationship between coaches and participants. All communications are transmitted through an encrypted connection using SSL (Secure Sockets Layer) and participants are only identified by a pseudonym. The coach keeps the real name and contact information separately from the system under lock and key. Access to the application is only given through the partner institutions (research hospitals or clinical units): no participant will be given access freely over the Internet without supervision or monitoring by a trained coach.

The online version of the SHG was released in September 2002 and is currently available in French, Spanish, and Swedish. English, German and Italian versions are also available for testing. Clinical trials were launched in October 2002 and are continuing until January 2004 in four countries. Final results are expected by first quarter 2004. The SHG research is already providing interesting feedback on the use of online tools for collaborative research, and novel cost-effective treatment strategies.

On the clinical side, first impressions are that the application is easy to use, the online evaluation and the e-mail contacts, monitoring of patients' progress is fast and saves time. One main conclusion from the clinical point of view is that this application can be part of a stepped care approach. Patients are interested in being able to get treated by themselves and are rather motivated by the e-mail contacts and feedback given by the computer.

Security and privacy was a main concern and had to be addressed by keeping a good balance between security and ease of use. This concern was satisfied by a combination of technical (e.g. SSL encryption) and procedural solutions (e.g. use of pseudonyms within the system).

The online application also optimised the process of collection and analysis of research data: patient exercises are submitted directly online and statistical data can be downloaded from the database to a statistical software package for analysis, thus saving time and reducing error that can occur when transcribing results from paper to computer.

First results of the clinical trials are promising and the online application has exhibited several advantages. Patient acceptance is high. In addition, the multi-lingual scope of the application gives us the opportunity to deploy the SHG in most European countries and to easily expand its use to other languages. The opportunity for providing this service to a minority population is also perceived to be an unexpected benefit (e.g. providing the Spanish version of the SHG to the Spanish-speaking communities in Sweden).

Moreover, the Web-based SHG is based on a generic platform for the delivery of e-health / e-mental health services. This platform, by its modularity, could allow the rapid deployment of other self-help applications based on CBT, e.g. panic disorder, pathological gambling, etc.

Early results also indicate that making some mobile SHG modules could also extend accessibility and convenience. A prototype for accessing some of the SHG tools via WAP has been implemented, and we are starting to look at ways to integrate mobile technologies more completely in the platform to provide seamless and secure access to the SHG.

Key words
e-mental health, online therapeutic tools, eating disorders, cognitive behavioural therapy, clinical trials, patient empowerment, self help manuals

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