Effectiveness of a novel integrative online treatment 1 Running head : INTEGRATIVE ONLINE DEPRESSION TREATMENT Effectiveness of a novel integrative online treatment for depression ( Deprexis ) : Randomized field trial

Background: Depression is associated with immense suffering and costs, and many patients receive inadequate care, often because of limited treatment availability. Web-based treatments may play an increasingly important role in closing this gap between demand and supply. We developed the integrative, web-based program Deprexis covering therapeutic approaches such as behavioral activation, cognitive restructuring, mindfulness/acceptance exercises, and social skills training. Objective: To evaluate the effectiveness of the web-based intervention in a randomized field trial. Methods: 396 adults were recruited via internet depression forums in Germany and were randomly assigned in an 80:20 weighted randomization sequence to either 9 weeks of immediate-program-access as an add-on to treatment-as-usual (N = 320), or to a 9-week delayed-access plus treatment-as-usual condition (N = 76). At preand post-treatment and 6month follow-up, we measured depression (Beck Depression Inventory) as the primary outcome measure and social functioning (Work and Social Adjustment Scale) as the secondary outcome measure. Completer analyses and intention-to-treat analyses were performed. Results: Of 396 participants, 216 (55%) completed the post-measurement nine weeks later. Available case analyses revealed a significant reduction in depression severity (BDI), Cohen’s d = . 64 (CI 95%=0.33-0.94), and significant improvement in social functioning (WSA), Cohen’s d =. 64, 95% (CI 95%=0.33-0.95). These improvements were maintained at 6-month follow-up. Intention-to-treat analyses confirmed significant effects on depression and social functioning improvements (BDI: Cohen’s d=0.30, CI 95%=0.05-0.55; WSA: Cohen’s d=0.36, CI 95%=0.10-0.61). Moreover, a much higher percentage of patients in the intervention group experienced a significant reduction of depression symptoms (BDI: odds ratio [OR]=6.8, CI 95%=2.90-18.19) and recovered more often (OR=17.3, 95% CI 2.3-130). More than 80% of the users felt subjectively that the program had been helpful. Conclusions: This integrative, web-based intervention was effective in reducing symptoms of depression and in improving social functioning. Findings suggest that the program could serve as an adjunctive or stand-alone treatment tool for patients suffering from symptoms of depression. Ashridge Business School http://www.ashridge. org.uk Effectiveness of a novel integrative online treatment 3 Effectiveness of a novel integrative online treatment for depression (Deprexis): Randomized field trial Introduction Depression is associated with immense personal suffering and—due to treatment expenses and lost productivity—with high costs to the individual and society [1-3]. Despite the enormous burden imposed by depression, and even though depression is clearly treatable [4], many sufferers still receive only inadequate or no treatment at all [5-8]. For example, it has been estimated that only 10% of the four million people who suffer annually from depression are treated adequately in a well developed healthcare system such as the one established in Germany [9]. In other countries, similar problems are evident. For example, in the early 2000s, fewer than 25% of adults with major depressive disorder in the US received the recommended appropriate treatment [10]. The World Health Organization has estimated that during a 12-month period, about 14 million depressed individuals in Europe and 20 million in North and South America (combined) remain untreated [11]. Many depressed patients who could benefit from treatment also remain on waiting lists for long times or do not engage with treatment due to geographical inaccessibility, prohibitive costs or other reasons, such as a preference for self-help [8]. The evidence shows that depressed patients who remain on waiting lists continue to report high levels of distress, even over many months [12]. What can be done to help more of these patients quickly and efficiently? In the UK, experts have recommended the training of 10,000 new therapists and the creation of new treatment delivery systems [13]. Similarly, a workgroup commissioned by the US National Institute of Mental Health [14] has recommended the development of innovative treatments that can be delivered at low costs to large populations. Specifically, the workgroup noted that “the internet affords the opportunity to make psychosocial interventions available to large segments of the public. Interventions can be delivered programmatically and reliably, greatly extending the numbers and types of people who can be reached with services” [14, p. 623]. In recent years, web-based approaches have been increasingly used and it has been repeatedly shown that internet-delivered treatments may be an effective and inexpensive alternative to traditional treatments [15-17]. Most of the existing internet-based depression treatments are based on cognitive-behavioral principles, although other modalities, such as problem-solving therapy, appear promising as well [18]. The purpose of the project described here was to develop a novel, integrative program that could be delivered via the internet to reduce symptoms of depression. The name Deprexis was chosen because it expresses which symptoms are targeted (i.e., depression), and it conveys the idea that active practice is an inherent part of the treatment. The word is a combination of depression and praxis—a word of Greek and Latin origin denoting deed or action. The aim of this paper is to describe an initial study of its effectiveness. Methods Recruitment of Participants The study was conducted between February of 2007 and June of 2008. Participants were recruited via advertisements posted on the internet (e.g., by posting brief notices on depression-related internet forums in Germany, given the permission of the forum administrators). Upon establishing contact via email, potential participants received a detailed response-email describing the project and inviting them to complete a set of online questionnaires. The email also informed potential participants that the program was not intended to replace psychotherapy or medical treatment and did not entail personal interactions with any treatment provider. Additionally, it explained that participants would be randomly assigned to one of two conditions: Nine weeks of access to an online self-help Ashridge Business School http://www.ashridge. org.uk Effectiveness of a novel integrative online treatment 4 program or nine weeks in a waitlist/delayed-access condition. Only those who provided consent, were above the age of 18 and completed at least half of the baseline depression questionnaire were included in the study. Similar to some previous studies in this area (e.g. [18]) no other inclusion or exclusion criteria were used. The study was approved by an internal review board (IRB) in Germany, where the study was conducted. Intervention The Web-based intervention consists of ten content modules representing different psychotherapeutic approaches, plus one introductory and one summary module, each of which can be completed in 10 to 60 minutes, depending on the user’s reading speed, interest, motivation and individual path through the program (see Figure 1 and Multimedia Appendix for screenshots). Modules are organized as simulated dialogues in which the program explains and illustrates concepts and techniques, engages the user in exercises, and continuously asks users to respond by selecting among response options. Subsequent content is then tailored to the users’ responses, resulting in a simulated conversational flow. All modules are accompanied by illustrations (e.g., drawings, photographs, flash animations). The program version that was evaluated in this study did not include audio or video features in order to increase accessibility by reducing the requirements for broad bandwidth and specialized hardware or software. Figure 1: Example screenshot (see multimedia appendix for additional examples) The modules cover a variety of therapeutic content that is broadly consistent with a cognitivebehavioral perspective, although the program is not restricted to one CBT manual. Instead, an effort was made to design the program as an integrative treatment tool that provides a variety of relevant therapeutic approaches and fits within the broad array of contemporary CBT. The modules’ theoretical rationale and content are briefly summarized below: (1) Behavioral activation and (2) cognitive modification. There is strong evidence that CBT techniques such as cognitive restructuring (e.g., identifying and refuting unhelpful automatic thoughts, recognizing cognitive distortions, etc.) and behavioral activation (e.g., scheduling potentially enjoyable activities) are effective in the treatment of depression [4, 19, 20], so their inclusion in web-based programs appears justified. Some controversy remains, however, with regard to the necessity of the cognitive elements of CBT packages. In some studies, Ashridge Business School http://www.ashridge. org.uk Effectiveness of a novel integrative online treatment 5 behavioral activation alone has been as effective as, or even outperformed, the more cognitive CBT interventions [21-23]. In line with most CBT packages for depression, one Deprexis module was designed with a focus on behavioral activation (BA) and another with a focus on cognitive restructuring. The BA module incorporates standard BA principles and procedures, as described in existing manuals [e.g. 24, 25], but also contains modifications. For instance, users are encouraged to schedule activities that have the potential to satisfy basic psychological needs: the needs for social relatedness, autonomy, competence, self-esteem and hedonic enjoyment. This needsatisfaction aspect is not a traditional element of BA but is a key feature of other treatments that have garnered empirical support, such as Grawe’s integrative therapy (a treatment that is well-known