European Comparative Effectiveness Research on Internet-based Depression Treatment

E-COMPARED Newsletter December, 2015

E-COMPARED is funded by the European Community’s

Seventh Framework Programme (FP7) under grant agreement No. 603098

A collaborative project of partners from 11 European countries

www.ecompared.eu info@e-compared.eu

Dear reader Very welcome to this first issue of the E-COMPARED newsletter. We are proud to present you some information, news, first results and experiences from this European project on Internet-based Depression Treatment.

I would like to take this opportunity and thank all the partners, therapists, patients and stakeholders for the very successful collaboration and their engagement.

If you have any questions regarding the E-COMPARED project please contact info@e-compared.eu.

We are happy to answer your questions and would greatly value your feedback.

We hope that you enjoy reading !

Dr. Tobias Krieger University of Bern, Switzerland tobias.krieger@psy.unibe.ch

editedbyT.Krieger

NEWSLETTER CONTENTS

Project Info •  E-COMPARED in a nutshell .......................................................... Page 2 News •  News of E-COMPARED ................................................................. Page 3 Thoughts About the Project •  New directions in Internet-based treatments for mental

disorders ....................................................................................... Page 4 •  “Blended Treatment”? ................................................................. Page 5 •  The “E” of E-COMPARED............................................................... Page 6 Project Results •  Current state of treatment as usual of adult depression

treatment in Europe: First results from E-COMPARED ................ Page 7 •  First impressions of the “E” from patients: Results from the UK . Page 8 1

E-COMPARED in a Nutshell

• Evaluate EU mental health policies/guidelines for standard and Internet-based care for depression in primary care and specialized mental health services in countries with different health care systems and access levels of standard and Internet-based care

• Compare clinical efficacy and cost-effectiveness of Internet-based blended treatment and treatment as usual within controlled research settings

• Predict which patient groups could benefit from Internet-based blended treatment vs. standard treatment by modeling patient characteristics

• Develop evidence based recommendations on how Internet-based blended depression treatment can be cost-effectively integrated into routine primary and specialized care systems for depression in EU mental health care systems, and develop a business case to ensure structural implementation of these services in routine care

Consortium of the E-COMPARED project at Kickoff-Meeting at the VU University in Amsterdam, 2014

A Real European Project In 2010, 30 million Europeans were affected by depression and their number is still growing. Half of Europeans in need of mental care for depression do not have access to care services, do not al-ways receive evidence-based treat-ments, are confronted with long waiting lists or high care expenditures. Internet-based treatment has the po-tential to address the drawbacks of standard care and keep depression treatment of high quality and affordable. And this is what we are going to study ! The European project E-COMPARED conducts comparative effectiveness research in routine specialized mental care and in primary care settings on the (cost-) effectiveness of Internet-based treatment for depression in comparison with standard care. Health care systems, and -policies, existing ICT infrastructures and their uptake will be taken into account. The principal investigator of this project is Prof. Dr. Heleen Riper. She and her team manage the project at the VU University Amsterdam in the Netherlands.

Prof. Dr. Heleen Riper VU University of Amsterdam Principal investigator of E-COMPARED Netherlands h.riper@vu.nl

The E-COMPARED objectives

Working together! The E-COMPARED members are from the following 15 institutions from 11 different countries.

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News of E-COMPARED

In all participating countries the two arm multisite randomized controlled non-inferiority trials comparing internet based blended CBT for depression to treatment as usual have started and patients are recruited. The settings are either in routine primary care (PL, ESP, UK, SE, DE) or in specialized mental health care (NL, FR, CH). Participants in both conditions will be followed until 12 months after baseline. Furthermore, an additional trial of an associated partner of the E-COMPARED project in Denmark is underway. So far approximately 320 patients have been included in the different trials. A generic study protocol of the E-COMPARED study will be published soon.

E-COMPARED is European. The 3rd consortium meeting took place on the 12th and 13th of October 2015 in beautiful Porto (Portugal), in order to work closely together towards the goals of this international, Europe-wide project. The interdisciplinary character of this project was evident, since 42 participants from different fields (Psychology, Health technology assessment, Information and communications technology, Health care) took part. The consortium is highly professional since many front runners in Internet-based treatments for common mental health disorders are represented in the consortium. Many thanks to Dr. Artur Rocha (INESC TEC, Porto) and his team for the great organization!

•  3rd Consortium Meeting in Porto

•  Effectiveness Trials Update

•  Important Upcoming Event It is important to spread the word about the E-COMPARED project and its results not only on a European but also on an even more international level. A next opportunity to do so is the 8th Scientific Meeting of the International Society for Research on Internet Interventions (ISRII) taking place from the 7th – 9th of April 2016 in Seattle (USA). The collaboration with this society is very closely not only because the principal investigator of E-COMPARED Prof. Dr. Heleen Riper is the current president of the ISRII. Furthermore, also other members of the E-COMPARED consortium are part of the ISRII board (Dr. David Daniel Ebert; Prof. Dr. Gerhard Andersson, PhD; Prof. Dr. Christina Botella, PhD; Prof. Dr. Pepijn Van De Ven). The ISRII 8th Scientific Meeting theme is 'Technologies for a digital world: Improving health across the lifespan’. The conference will have a broad scope focusing on digital technologies to improve health across the lifespan and will cover lifestyle behaviors, management of acute and chronic conditions, and mental health. More information about the conference can be found under www.isrii-conference.com/

New Directions in Internet-based

Treatments for Mental Disorders

What kind of Internet treatments exist? Research on Internet-based treatments has grown rapidly over the recent years and evidence is growing that some forms of internet interventions often result in similar outcomes as conventional face-to-face psychotherapy (Andersson, Cuijpers, Carlbring, Riper, & Hedman, 2014). There are various forms of internet interventions. A common distinction relates to the intensity and amount of therapist contact and support provided during treatment. There are (a) self-guided programs that only use the internet to provide information and that do not include any contact with a clinician during treatment, (b) guided self-help approaches, in which the presentation of a self-help program is combined with minimal but regular therapist contact (often via secured e-mail), and (c) Internet-based psychotherapies such as e-mail, chat or videoconferencing therapies, in which the internet is exclusively used as a communication medium between the therapist and patient.

Internet-based treatments work! While there are not many controlled trials on e-mail-, chat- or videoconferencing therapies (e.g. Kessler et al., 2009; Vernmark et al., 2010), the number of studies on Internet-based self-help interventions is exceeding one hundred (Hedman, Ljotsson, & Lindefors, 2012). Many of the studies evaluated guided self-help treatments which require considerably less therapist time than face-to-face psychotherapy because the main component of the intervention is a web-based self-help program. Most of these programs are based on cognitive behavioral therapy, though there are recent studies following other approaches such as psychodynamic therapy (Andersson et al., 2012). The efficacy of guided self-help interventions has been demonstrated for a variety of mental disorders (e.g. anxiety disorders, depression) and health concerns associated with bodily symptoms (e.g. tinnitus, sexual dysfunction). Evidence consistently suggests that guided internet inter-ventions provide equivalent outcomes compared to face-to-face psychotherapy (Andersson et al., 2014). Moreover, data from several effectiveness studies show that these interventions seem to work just as well in routine clinical practice as in research studies (Andersson & Hedman, 2013).

The role of “guidance” An important discussion concerns the role of the therapist in Internet-based self-help treatments. Evidence from meta-analyses (Richardson, Richards, & Barkham, 2010; Spek et al., 2007) suggests a superiority of guided versus unguided self-help interventions, i.e., interventions that do not include an interaction with a therapist. The main problems of unguided self-help programs are the usually rather low adherence to treatment, i.e., patients don’t use the program as they should, and the high drop-out rates. However, in some studies on unguided treatments in which contact with a clinician was established before the treatment started there was no difference between the guided and unguided format (e.g., Berger et al., 2011).

Combining the best of two worlds? Internet-based interventions have several advantages and disadvantages. Main advantages include: easy accessibility, easy use independent of time and place at a self-determined pace, high level of anonymity and privacy which is for many persons with a mental disorder an attractive feature due to their fear of stigmatization and low cost of delivery to large populations. Moreover, such interventions may also help to bridge waiting times for face-to-face treatments and to ensure lasting change. However, there are also risks and challenges associated with internet interventions. A common concern relates to how therapists deal with crisis, e.g., when a client becomes suicidal. Another risk is that patients do not apply the treatment in an appropriate fashion and/or are not appropriately diagnosed when they start working with an Internet-based program. Most of these concerns can be adequately addressed in online interventions, e.g., by excluding suicidal patients, developing emergency plans with patients, including diagnostic interviews and monitoring patients. However, specific measures have to be considered and taken.

Let‘s blend and investigate it Most of the research on internet interventions has focused on interventions completely delivered via Internet. Less is known about blended treatments in which internet interventions and regular face-to-face therapy sessions are combined. The present large-scale European project E-COMPARED (www.ecompared.eu) has just begun to investigate the clinical and cost-effectiveness of blended treatments. This is an important endeavor, since it is possible that some of the shortcomings of both settings can be compensated by combining them. There are some promising preliminary findings on blended treatment formats. For instance, Ly et al. (2015) compared a ten session face-to-face behavioral activation treatment for depression with a four session face-to-face treatment combined with the use of a smartphone app devoted to behavioral activation. The shorter, less (therapist) time consuming blended treatment was found to be just as effective as the ten session treatment. Thus, the use of a smartphone app allowed for six fewer sessions without any loss of effect. However, it has to be shown whether the finding from this small study generalize into larger studies.

The field of internet interventions is a fast growing field. We try to briefly summarize the state-of-the-art in the field and describe new directions, in which the E-COMPARED project plays an important role.

Prof. Dr. Thomas Berger Dr. Tobias Krieger Dept. of Clinical Psychology & Psychotherapy University of Bern Switzerland tobias.krieger@psy.unibe.ch

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“This type of treatment [blended treatment, A/N] involves a combination (blending) of face-to-face treatment with Internet

sessions into one integrated treatment in such a way that it can be delivered in routine care settings.”

“Blended Treatment”?

“[…] blended treatment includes any possible combination of regular face-to-face treatments and web-based interventions. For instance,

treatment components of a web-delivered intervention may be integrated intensively and used during the face-to-face treatment,

[…]”

Since there is hardly any research on the positive and/or side effects of blended treatment, one goal of E-COMPARED is to fill this research gap by comparing blended treatment with routine primary and/or routine secondary usual care for depression with regard to clinical as well as cost effectiveness.

“[… ]a combination of online and face-to-face therapy, in which online sessions replace or substitute some (parts) of the sessions with a health professional […]. Patients would then receive a blend of face-to-face sessions with a health professional and modules in an online

program which they follow independently, while the actual duration of therapy stays equal or could become shorter.”

In the E-COMPARED project, treatment-as-usual is compared to blended treatment. But what exactly is blended treatment? In the following a few citations how blended treatment has been defined so far:

van der Vaart, Witting, Riper, Kooistra, Bohlmeijer, & van Gemert-Pijnen (2014), BMC Psychiatry

Kooistra, Wiersma, Ruwaard, van Oppen, Smit, Lokkerbol, Cuijpers, & Riper (2014), BMC Psychiatry

Krieger, Meyer, Sude, Urech, Maercker, & Berger (2014), BMC Psychiatry

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The “E” of E-COMPARED

No system, no trial In E-COMPARED, technology is key. Part of the therapeutic sessions of the blended treatment are delivered online. To test the clinical effects of this approach across the EU, web-based treatment delivery system had to be in place at each of the eight trial sites. This was critical. No systems, no trial. The technical set-up of the E-COMPARED study was a challenge. Some trial sites already used systems, but these systems needed to be updated to match the requirements of E-COMPARED. At other sites, new systems had to be introduced. But due to the experience and hard work of all project partners, the consortium managed this challenge well. Four systems, one idea In five countries, online sessions are delivered via the ICT4D/Moodbuster research platform, which was redesigned, refined, and extended with a Content Management System (CMS) to better facilitate treatment localisation. Partners in Sweden, Spain, and Switzerland adapted their own existing treatment systems (Iterapy, Smiling is Fun, and Deprexis, respectively). Four different systems, four different treatments? No. All systems implement the core therapeutic elements of the generic E-COMPARED treatment manual: psychoeducation, behavioral activa-tion, problem solving, physical exercise, cogni-tive therapy, and relapse prevention. Implemen-tation differences between the systems will probably introduce some variance in outcome; technology can be a filter or a catalyst of intervention techniques. Pooled data, however, will reflect effects of the common blended treatment manual.

Technical pilot tests As scheduled in the E-COMPARED plan, each treatment delivery system was systematically tested for its support of critical trial requirements by test teams throughout Europe, at local trial sites, in naturalistic settings. These technical pilot-studies were driven by a detailed common test-script that evaluated the technological readiness of the platforms, the usability of the user interfaces, their compliance to local and EU privacy regulations and their compatibility with local ICT configurations. These activities, part of Task 2.2 of Work-package 2 of the e-Compared project, are reported in Deliverable 2.3. More than 750 tests were run in the eight countries. This revealed numerous bugs and usability issues, which, in most cases, could be resolved by system developers on short notice. On completion of the pilot tests, some critical recommendations remained to be implemented for ICT4Depression and Smiling is Fun, but these were addressed and resolved prior the scheduled start of trial participant recruitment in each site. Scheduled systematic technical pilot tests led to focused development efforts that ensured technical treatment delivery platforms that posed no barriers for the E-COMPARED project to enter the trial recruitment phase. All trial partners accepted their system as a result of the pilot test as a usable tool for trial and treatment purposes. With the recent approval of Deliverable 2.3, this was officially recognized by the EU.

Visual walkthrough for download For publications, presentations, workshops and other dissemination activities of project partners, we prepared a PowerPoint presentation of the ICT4D/Moodbuster system. In 100 slides with high-resolution figures, this PowerPoint provides an impression of the system in the form of a visual walkthrough, from both the client and the therapist perspective. The figures below are a sample. This PowerPoint also contains instructions how to experience the look and feel of Moodbuster yourself, at http://moodbuster.eu, via a demo client account. The PowerPoint can be downloaded from the secure E-COMPARED project site. If you experience any difficulties in accessing it there, I am happy to share it through e-mail (j.j.ruwaard@vu.nl).

Fig. 1: The Moodbuster Mobile EMA App

Fig. 2: Moodbuster Homepage 6

Next steps Software development is never finished. It thrives on user feedback, in continuous development cycles. Once applied in routine practice, new bugs and features will be identified. If you encounter technical issues in using the Moodbuster, please let us know at tech-support@moodbuster.eu. In the meantime, I wish the consortium the best of luck with participant recruitment, treatment and data collection. I am looking forward to the results!

Fig. 3: Moodbuster Module Overview

Dr. Jeroen Ruwaard Technical Coordinator E-COMPARED, VU University of Amsterdam Netherlands j.j.ruwaard@vu.nl

Current State of Treatment as Usual of

Adult Depression Treatment in Europe:

First results from E-COMPARED

European state of the art in depression treatment A first report from the E-COMPARED project coordinated by Prof. Gerhard Andersson (University of Linköping, Sweden) and his team pursued the aim to investigate the current state of treatment-as-usual of adult depression treatment in routine practice, Internet-based treatment for depression and blended treatment of depression in Europe. Differences between countries In general, first results indicated that there is a marked difference in availability and support for Internet-based depression treatments throughout Europe, associated to between-country differences in terms of e-health implementation and associated preconditions such as reimbursement policies. Mental health care stakeholders’ knowledge of Internet treatment varies, but potential benefits of Internet-based treatment such as increased capacity in mental health care system are readily identified.

Blended treatment is favoured Blended therapy (blending traditional face-to-face and internet therapy) for depression was generally viewed more favourable compared to stand-alone Internet-based therapy. A majority of stakeholders indicates that their organisation would/did recommend blended therapy for mild (70.5%) and moderate depression (58.4%) respectively.

Promising preliminary results Finally, although the current number of studies is low, the systematic review and IPDMA showed up until now that blended treatments do provide promising results in terms of clinical effectiveness. It was further revealed that there is a gap regarding clear descriptions on what blended treatments exactly entail in terms of face-to-face versus online components. Regarding the current state of depression care in Europe, the report concludes that gaps exist between current practice and distributed care.

Ample need for more research Taken together, the report indicates that there is ample need for advancing research on blended depression treatments in Europe and for informing stakeholders about possibilities and boundaries of Internet-based and blended treatment for depression. The results of this survey and the associated research activities will be published soon in peer-reviewed expert journals.

Naira Topooco Dr. Kien Hoa Ly Prof. Dr. Gerhard Andersson Dept. of Clinical Psychology Linköping University Sweden naira.topooco@liu.se 7

The E-COMPARED team in the UK carried out focus groups with former service-users to explore percept ions and exper iences o f us ing Moodbuster in addition to face-to-face therapy. Thi rteen people who have experienced Depression and/or Anxiety in the past were recruited to form a service-user advisory group. Previous to the focus groups, advisory members were briefed on the blended nature of the intervention and were trained on how to use Moodbuster. Members were then allocated two modules to complete, Psychoeducation and one other module (cognitive restructuring, problem solving, and physical exercise). The focus groups explored a range of topics relating to usability and engagement. Based on the feedback from the first focus group (N=4), Moodbuster appears to be generally well received, with some advisors noting how helpful and enjoyable it was to use the online platform.

First Impressions of the “E” from Patients: Results from

the UK

While the platform was deemed to be well developed, the advisory group members agreed that it was not enough to produce successful therapeutic results on it’s on. Advisors spoke of this in relation to the need of human contact as a means of guidance and support, especially when symptoms are prominent, and motivation to engage in treatment is low.

“My overall opinion is that it is extremely useful. I changed my opinion, initially I was a little bit sceptical, but I thought it was very apt, and I did enjoy, and it was good for me. Not even as part of a [advisory group] project, but it was useful and interesting and I hadn't engaged in anything like this before.” [S.]

“I think the reflective element is very important and it’s a key part of experiential learning, it’s really good that it’s there. but again, having that also spaced out, writing down what you've learned, the connections you make, I think so you can keep them and possibly you know download them as well, that would be really helpful, because then you have something to refer back to, look back and think oh I found this useful…That's some way of creating a record, which you can look back at and that can prompt you know in your daily life as to what might help you, with regards to whatever you're facing.” [J.]

Others noted that the blended sessions could be useful in facilitating learning and reflection.

Users also noted the usefulness of different features of Moodbuster:

“[The Moodbuster platform is] Bright, organized, it’s attractive. That you have some idea of what's in it and, what you can gain from it [referring to the Moodbuster home page]”. [J.]

“The calendar was very important to me.…You can see it by the click of a ...forward and back…That was my experience. And the most positive thing I can say is that, over years, this would actually be more useful, than just about all my personal therapy sessions”. [S.]

“I guess when you're in a really dark place, I guess it's very hard to do it on your own. And you really just can't do something. If you were re luctant to meet someone [therapist]… so if you get as far as meet ing someone and they introduce this and you think, yeah I can try, and they [therapist] do it with you, because after all, it is about support I think. Umm, just to get you to your first goal, even if it’s a general goal, but I think it would be very difficult if you're completely on your own, if you are in the depths of this [depression].” [S.]

Having blended therapy was perceived as a mean of not only ensuring that everyone had access to useful information and techniques about treating depression, but also about getting feedback and reassurance during this process.

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Imprint © 2015, ECOMPARED Text: Members of the

E-COMPARED consortium

Although these quotes were taken from one focus group, these themes were mirrored in the feedback provided in other focus groups, which have yet to be transcribed. It is hoped that the data form the focus groups will be collated, analysed and submitted for publication in a peer reviewed journal in the New Year.  

“I suppose it increases continuity the patient experience because they’re all accessing and presenting with the same information, and of course there will be differences between therapists, but maybe the fact that information is the same for everybody is a good thing. …My clinical psychologist was really good at sharing information and being really clear and focussed, and maybe that made it really easy for me to know why things were relevant and how it linked in…. But she was really good at setting things up so I think that's important. And just in terms of feedback, if you don’t give [people] feedback, it's game over.” [L.]

Asmae Doukani Arlinda Cerga-Pashoja London School of Hygiene & Tropical Medicine United Kingdom arlinda.cerga-pashoja@lshtm.ac.uk

Contact Information

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We, the E-COMPARED

consortium, wish you a Merry Christmas and all the best for 2016!