An internet-based intervention for people with psychosis (EviBaS): study protocol for a randomized controlled trial

Schizophrenia and other psychotic disorders are severe mental disorders with heterogeneous symptom profiles encompassing positive symptoms such as persecutory delusions and auditory verbal hallucinations as well as negative symptoms such as social isolation and avolition [1]. In addition, they are accompanied by neuropsychological impairments in attention, memory, and executive functioning [2‐6]. Sleep is impaired in the majority of people experiencing persecutory delusions [7] and levels of worrying are high [8, 9]. Besides symptoms, stigmatization is a major source of distress in people diagnosed with schizophrenia [10], even in the context of mental health care [11]. Lifetime prevalence of schizophrenia is about 1% and stable across different regions of the world and cultures [12]. Schizophrenia is accompanied by an enormous individual and societal burden [13, 14] and lies on position eight of the leading causes of disability-adjusted life years in 15- to 44-year-olds [15]. About 65% of individuals with a first episode relapse during the subsequent three years [16], resulting in inpatient costs about two to five times higher compared to non-relapsed patients [17].

As a complementary or alternative treatment option to antipsychotic medication [18], cognitive behavioral therapy for psychosis (CBTp) has emerged as an evidence-based treatment option for patients with schizophrenia and related disorders [19‐24]. CBTp targets psychological mechanisms of symptom formation and maintenance that were primarily identified or corroborated using experimental psychopathology research [25‐27]. The therapeutic framework and techniques of CBTp are to a large extent similar to those of cognitive behavioral therapy (CBT) for depressive or anxiety disorders (cognitive restructuring, reality testing, etc.). For example, the distress (consequence) related to hearing voices (situation) is assumed to be determined not by hearing voices per se, but predominantly by automatic thoughts and the according belief system. Consequently, alternative helpful beliefs about voices established with the help of cognitive techniques are supposed to result in less distress [28]. CBTp is likely to be effective for patients who choose not to take antipsychotic medication, too [29]. In regular mental health care, the effectiveness of CBTp has also been asserted [30], and neurocognitive deficits, comorbidity and poorer functioning pose no barrier to improvement during CBTp [28]. Consequently, national regulations such as the United Kingdom National Institute for Health and Care Excellence (NICE) guideline recommend that CBTp should be offered to every person with psychotic symptoms [31].

Acceptance and Commitment Therapy (ACT) focuses on noticing rather than changing thoughts and feelings [32]. ACT seems to be effective in treating mental health problems [33]. In schizophrenia, ACT helps people to cope with psychotic experiences using strategies such as cognitive distancing, which is characterized by learning to see one’s belief as a hypothetical statement rather than a fact. Instead of trying to change, modify, or control odd cognitions or disturbing sensory states, patients are encouraged to instead simply be aware of these experiences [34]. A meta-analysis showed a medium-sized effect of ACT on symptoms of psychosis [35].

The third type of treatment is the Metacognitive Training for psychosis (MCT), developed specifically for people with schizophrenia [36, 37]. MCT invites participants to critically evaluate cognitive biases such as jumping to conclusions and overconfidence in their thinking (metacognition). These biases might increase the likelihood of psychotic symptoms [38]. Studies show that MCT is efficacious in reducing psychotic symptoms [39, 40].

Despite the availability of evidence-based treatments for schizophrenia, 69% of patients remain untreated in countries with low and middle income [41]. In particular, the need for psychosocial treatments including CBTp remains unmet [42]. Even in highly developed countries such as the United Kingdom or Germany, the treatment gap for schizophrenia is large. In theory, the NICE guidelines proclaim that CBTp is mandatory for the treatment of psychosis [31]. In practice, more than 50% do not receive even a single session of CBTp [43]. In Germany, CBTp is virtually not represented in the mental health service [44]. To sum up, CBTp is effective, recommended, and has great potential to alleviate psychological distress, but only a small fraction of patients with psychosis receives CBTp.

Internet-based cognitive behavioral therapy (iCBT) can help to overcome treatment gaps in many mental disorders [45]. In several psychological disorders, including anxiety and depression, internet-based treatments have proven to be efficacious and effective in randomized controlled trials (RCTs; for a comprehensive review, see [46]). Most of the growing body of evidence comes from studies evaluating guided internet-based self-help treatments. While patients work their way through a structured self-help program that is typically based on CBT manuals, therapists or coaches assist and support them via a secured e-mail system. Meta-analyses on internet-based treatments show a superiority of guided interventions in comparison to unguided, automated programs in terms of efficacy, adherence to treatment, and drop-out rates [47‐49]. Main advantages of guided internet-based treatments include: (1) low-threshold accessibility, (2) flexible usage independent of time and place at a self-determined pace, (3) high levels of anonymity and privacy (which is an attractive feature for many persons with a mental disorder due to their fear of stigmatization) and (4) low costs of delivery to large populations [50].

People diagnosed with schizophrenia use the internet [51] and are able and willing to use mental health services on the internet, such as peer-to-peer support [52]. The feasibility of internet-based treatments for people with psychosis (iCBTp) is well documented for web-based interventions [53, 54] and also reported for smartphone interventions [55]. However, current internet-based programs differ in their comprehensiveness and focus. For instance, mixed results have been reported regarding the efficacy of internet-based psychoeducation programs [56], and the efficiency of internet-based programs targeting medication management [53, 57]. There is a pilot study on a more comprehensive web-based, CBTp-oriented program for auditory verbal hallucinations, but this program was delivered via computers in mental health care centres (and not online). The study provided promising results using an uncontrolled pre-post-design (Cohen’s d = 0.58) [58]. None of the 21 participants with schizophrenia reported that the program was unhelpful and the authors report no adverse events, highlighting the feasibility of iCBTp in a computerized self-help format. A recent investigation of aforementioned program in an RCT design showed a comparable effect of the web-based intervention and usual care on levels of auditory hallucinations [59]. The study was able to show that patients with schizophrenia who used the web-based program, however, had increased significantly in social functioning and their knowledge about CBTp was larger than of those who did not use the program. In another study that investigated iCBT for people with schizophrenia, the web-based program specifically targeted comorbid depressive symptoms. The intervention lead to a significant decline in depression severity [60].

In summary, there is preliminary evidence that iCBTp for people diagnosed with schizophrenia could be beneficial. However, to the best of our knowledge, no larger trials on comprehensive treatments have been conducted. The overarching goal of this RCT is to evaluate a guided internet-based self-help intervention for people with psychosis. We developed a web-based program that is comprehensive in many respects: The program is not only based on CBT but also includes elements from its third wave, specifically ACT and MCT [34, 36]. Schizophrenia patients often have comorbidities, such as depression, which should be addressed in an appropriate treatment [61]. This program offers additional interventions for such comorbidities. Disrupted sleep and worrying, among other secondary symptoms, are crucial in the formation and maintenance of psychotic disorders [25]. These factors are considered in the intervention as well. According to a review, the effects of smartphone-enhanced self-help are promising [62]. The intervention therefore includes an accompanying smartphone app for access in symptom-relevant situations in daily life. The app is expected to facilitate a transfer of skills to real world settings. Finally, a specific goal of the intervention was not to overstate negative consequences of the disorder [63] and solely focus on deficits, but to specifically target resources of the participants [64].

Treatment adherence in schizophrenia has been a well discussed topic predominantly in medication treatment [65]. But also in psychological treatments, rather high dropout rates are reported (e.g. prematurely terminated treatments by 45% of patients) [66]. This led us to look for factors that might influence treatment adherence. Among others, suggested mediators are treatment motivation [67] and working alliance with the therapist [68]. Overall, the study tests whether a comprehensive internet-based self-help program with an accompanying smartphone app reduces symptomatology in people with schizophrenia.

EviBaS has been developed as one of the first fully encompassing iCBT programs for people with psychosis. People with schizophrenia spectrum disorders suffer from a heavy burden of symptoms and stigmatization [13]. Psychological evidence-based treatments for schizophrenia exist, but only a small portion of affected people receive them [120]. Bridging the treatment gap in the psychological care for people with severe mental disorders is therefore of utmost importance. This project wants to reach people who do not receive psychological treatment but are looking for support. Internet-based interventions might even be able to reach a group of patients that discontinued a previous face-to-face therapy [121]. Given the efficacy of CBTp on hallucinations and delusions [122], as well as of iCBT in other mental disorders [46], the EviBaS self-help program is expected to reduce symptomatology. Negative effects and long-lasting effects of the treatment will be assessed. This study will also add to our understanding of how people with schizophrenia use internet-based interventions.