Cost-effectiveness of the mobile application TCApp combined with face-to-face CBT treatment compared to face-to-face CBT treatment alone for patients with an eating disorder: study protocol of a multi-centre randomised controlled trial

In the last three decades, Eating Disorders (EDs) have become a particularly relevant public health concern due to their growing incidence, the severity of the associated physical and psychiatric comorbidities [1], the high suicide and mortality rates [2] and the resistance of patients to treatment [3], among other reasons. In addition, they constitute today the third most prevalent chronic illness among the adolescent female population in developed and westernized societies and a public health priority around the world [4, 5]. Specifically in Spain, 75,000 adolescents are affected by one of the different manifestations of the disorder, among which 90% are female [6].

Although we do not have specific data related to the economic burden of treatment in Spain, various Cost Of Illness (COI) studies conducted in other European countries indicate that the direct costs for diagnosis and treatment of patients (medical expenditures, nonmedical costs, out-of-pocket expenses of the patient and his/her family), together with the indirect costs (loss of productivity due to sickness, reduced productivity or death) imply a high economic impact [7] and a significant loss of quality of life for people affected [8, 9] and their families [10]. However, according to the systematic review conducted by Stuhldreher et al. (2012), COI studies are sparse, the costs are often underestimated, the majority target only outpatient settings, and due to their heterogeneous nature, it is impossible to carry out comparisons between studies.

The widespread use of new technologies offers a promising and innovative way to improve the quality of care for patients with an ED and to reduce its economic burden. Systematic reviews of the literature demonstrate the effectiveness of eHealth as a complementary therapeutic tool in the treatment of EDs [11‐16]. For example, Internet-based interventions have proved their efficacy in reducing ED-related symptoms in a number of Randomised Controlled Trials (RCTs) [17‐19]. However, to date, there is a complete absence of RCTs evaluating the effectiveness of mHealth interventions for EDs and existing studies only offer preliminary results about acceptability and usability of such tools [20‐22].

In particular, mHealth interventions for EDs may help patients to increase their treatment adherence and to better deal with feelings of stigma associated with face-to-face psychological treatment. Additionally, considering the shortage of ED specialists and the long waiting lists in mental health outpatient settings, mHealth interventions may offer improved accessibility and availability of treatment, at lower costs [20].

In addition, it is worth noting that traditional Cognitive Behavioural Therapy (CBT) is considered the “gold standard” treatment for EDs. CBT uses real-time self-monitoring of patients’ eating habits and behaviours to help them gain a clearer picture of their problem and understand what triggers their behaviour and what are the consequences of it. Self-monitoring is the key driver of behavioural change as it helps patients intervene in the moment [12]. By doing so, all the relevant information regarding the eating problem is entered in real time and can be recovered repeatedly when the therapists or the patients want. Although the efficacy of online CBT interventions as alternatives to face-to-face treatment for patients with EDs is rather controversial [13, 23], such interventions may have a lot of advantages when used as therapeutic tools. Within this context, smartphone apps can offer an attractive and personalised treatment option and can reach a wider range of patients with low motivation for change or others who desire anonymity. Self-monitoring could be enhanced through smartphone-based interventions, as data entry is simpler than traditional pen-and-paper methods. In addition, reminders and motivational messages as well as bidirectional interactions between patient and therapist can improve adherence to treatment [24].

Nevertheless, while growth in mHealth interventions has been rapid, advances in the existing evaluation frameworks have not been seen [25‐27]. As a result, a huge number of health apps are widely available to the general healthcare public without possessing best-practice guidelines and certifications or a standardised validation process to assess their long-term cost benefits [28].

The TCApp¹ represents a tool for connecting patients and therapists in the time between medical consultations. It is currently available on Google Play and Apple Store markets, there are more than 412 patients who are currently using it and has been developed in collaboration with different public and private mental health institutions in the Barcelona area (Althaia, Hospital de Sant Rafael, CST, ITA and Hospital Sant Joan de Déu). The TCApp was designed from the very beginning with therapists’ and patients’ needs and interests in mind. By using the TCApp, patients and therapists are in continuous contact, allowing for a quicker reaction from the therapist according to the patients’ needs.

Through the TCApp, patients can record their thoughts, actions, emotions and whatever the therapists consider relevant for the therapy, since the app can be customized according to the therapy requirements of each specific patient. It involves algorithms based on artificial intelligence that can generate alarms when strategic words (i.e. suicide, death, etc.) are written. It also introduces technologies to allow real-time online contact with therapists and gamification aesthetics with prizes, rewards and reminders to improve patients’ engagement.

The back-office tool for therapists is a web-based platform where therapists can see in real time what their patients have registered (i.e. generation of graphs in a period of time to see parameter comparison and patient evolution) and they can interact in real time with them, using PUSH notifications. The tool is integrated in Azure server in order to ensure accordance with the most restrictive data protection laws and it is prepared for the integration in local management systems of hospitals and clinics. Lastly, there is currently no application available to provide the same services and benefits as the TCApp as most of the available applications contain self-help functionalities, rather than allowing for a bidirectional link between the patient and the therapist.

The purpose of this trial is to conduct a multicentre, randomized controlled trial with 250 patients diagnosed with an ED. In this experiment, the patients from the experimental group will test a mHealth application (TCApp developed by HealthApp) and then, a clinical efficacy analysis and economic evaluations will be performed. To do this, we have set the following three specific objectives:

The implementation of the intensive intervention program (TAU + TCApp) would result in a more significant improvement of the ED symptoms compared to the TAU control group. More specifically:

In this article  we present the protocol of a study aimed to assess the clinical efficacy of an intensive intervention program using the TCApp. In addition to the assessment of changes in ED pathology and other secondary outcomes, such as anxiety, depression and quality of life of both patients and their caregivers, we will assess the differential cost-effectiveness of an intensive treatment (TCApp + TAU) compared to that of TAU. This is an important strength of this study because to our knowledge, there are only a few apps for mental disorders with supporting evidence from RCTs and none of them was specifically designed for people with EDs or ED professionals [11, 61]. Once the TCApp has proven to be an efficient and cost-effective tool for use in ED units in Spain, the long-term contributions of the current study are as follows: 1) to promote the clinical use of the TCApp in ED units not only in Spain but also on an international level, 2) to improve the quality of patient care using the TCApp as complementary tool alongside face-to-face psychological treatment, while reducing direct and indirect costs associated with the treatment of the illness and 3) to explore the future use of the application in other mental disorders whose treatment is based on CBT, such as depression, addictions and anxiety.

Among the strengths of the study is its large sample size, which is clinically relevant, as it will be recruited from different public and private ED units in Spain. Another strength is the use of face-to-face assessment and a diagnostic interview to establish patient’s clinical diagnosis and confirm his/her final inclusion in the study, according to the inclusion and exclusion criteria. Furthermore, the assessment of the experience of caregivers is another strength worth mentioning.

Regarding the limitations of the study, the short follow-up time as well as the delayed access to the TCApp by the control group, which may influence our results, should be mentioned. Finally, a limitation related to the nature of the study is the fact that it is a multi-centre study that includes several private and public ED units in Spain. To overcome this limitation, when performing the statistical analyses, between-centre heterogeneity will be explored in subgroup analyses.