Elsevier

Journal of Affective Disorders

Volume 241, 1 December 2018, Pages 436-445
Journal of Affective Disorders

Research paper
OpenSIMPLe: A real-world implementation feasibility study of a smartphone-based psychoeducation programme for bipolar disorder

https://doi.org/10.1016/j.jad.2018.08.048Get rights and content

Highlights

  • So far, many mental health internet-based platforms (IBP) were developed and tested.

  • Few of these IBPs were made widely available for mental health patients.

  • OpenSIMPLe evaluated the large-scale implementation of an IBP for bipolar disorder.

  • Positive outcomes regarding satisfaction, usability and helpfulness were found.

  • Attrition rates were high, requiring further research about retention factors.

Abstract

Background

Few evidence-based mental health apps are widely available to patients and, conversely, many of the available apps have not been appropriately evaluated. Given that the ultimate goal is to scale-up and open internet-based platforms (IBP), it is crucial to appropriately evaluate their real-world feasibility beforehand. We aimed to evaluate the implementation feasibility of a smartphone-based psychoeducational programme for bipolar disorder, exploring its long-term retention, usability, perceived helpfulness and satisfaction, alongside its impact on secondary health outcomes.

Methods

Participants were recruited via the project website after completing an online screening questionnaire. They were requested to complete web-based questionnaires before using the app and after 6 months of use which included sociodemographic, illness and treatment variables, the world health organisation-five well-being index (WHO-5) and the short form health survey (SF-36). The follow-up questionnaires also contained satisfaction and usefulness questions.

Results

201 participants took part in the study. According to their retention, 66.2% of the participants were classified as nonsingle bondcompleters and 33.8% as completers. The only predictor significantly associated with higher odds of retention was older age (OR = 1.021, p < 0.001). 62% of the users reported they were satisfied with the programme with a higher percentage among completers. Who-5 baseline and follow-up scores showed a significant improvement as well as 6 out of 8 domains of the SF-36.

Limitations

Screening and outcome measures were administered using exclusively self-reported online methods.

Conclusion

The 6-month attrition rate of the programme was high. Positive outcomes regarding satisfaction were found predominantly among completers. The optimal dosage and retention of IBP mental health programmes remain challenging issues that need further research.

Introduction

The high prevalence of mental health disorders in comparison to the limited availability of traditional healthcare resources has led to an increasing interest in new cost-effective methods which could meet this growing demand and burden (Kessler et al., 2007, Whiteford et al., 2013). Given their growing, ubiquitous and broad accessibility, internet-based platforms (IBP) have frequently been proposed as a potential solution for reaching wider populations and increasing large-scale availability of health services, while simultaneously reducing costs. Thus, over the last twenty years, several projects have explored the possibility of providing adjunctive interventions through a wide array of e-mental health approaches for the most prevalent mental disorders (Lal and Adair, 2014).

Despite the initial optimism around IBPS in the mental health field and some positive findings regarding their efficacy, few projects have successfully implemented the platforms they evaluated (Buntrock et al., 2016, Firth et al., 2017, Wozney et al., 2017a). Most remained as researchsingle bondonly platforms never accomplishing their ultimate aim of becoming mental health care services in the real world (Meurk et al., 2016, Wozney et al., 2017a). conversely, many platforms and smartphone applications (apps) which were not properly evaluated ended up being widely available mainly due to an increasing pressure of stakeholders (Ruwaard and Kok, 2015) and the lack of clear validation guidelines and policies to regulate these new technologies (Charani et al., 2014, Lewis and Wyatt, 2014, Torous et al., 2016). In fact, few of the currently available e-mental health apps provide contents in accordance with established self-management or practice guidelines standards (Bakker et al., 2016, Nicholas et al., 2015).

Among the most prevalent of mental health disorders, bipolar disorder (BD) is a chronic, recurrent and disabling condition affecting more than 2% of the world population (Merikangas et al., 2011, Whiteford et al., 2013). It consists of acute episodes of mood fluctuations and long-term sub-syndromal symptoms which have a significant negative impact on patients´ quality of life, cognition, and life expectancy (Martínez-Arán et al., 2004, Michalak et al., 2005). In this context, simple (self-monitoring and psychoeducation in patients with BD with a smartphone application) is a nonsingle bondcommercial academic project set out to develop and validate several IBPS and, amongst them, a self-management smartphone app for patients with BD. the app collects continuous information about symptomatology while offering personalized psychoeducation messages as an addition to treatment as usual in order to prevent relapses (Hidalgo-Mazzei et al., 2015). The psychoeducational contents are based on a face-to-face group psychological programme developed and extensively evaluated by our group (Colom et al., 2009, Colom and Vieta, 2006). It is worth mentioning that both efficacy and cost-effectiveness results were positive and the programme showed a significant reduction of the number of episodes to a half in the 5 years follow-up as well as improving other relevant clinical outcomes in BD (Colom et al., 2009). Unfortunately, despite being recommended as a first-line psychological treatment for maintenance in most international guidelines, the program did not make it in terms of implementation and dissemination. Hence, the ultimate goal of the simple project is to extend, personalize and facilitate the wide access to the psychoeducational contents of the programme around the world to everyone who may need it.

The early feasibility, acceptability, safety and user satisfaction of the first version of the app (SIMPLe 1.0) was evaluated in a 3-month study involving more than 50 patients with BD and showed positive and encouraging results (Hidalgo-Mazzei et al., 2016). Moreover, post hoc analyses also suggested some potential improvements in terms of the biological rhythms of the patients and medication adherence (Hidalgo-Mazzei et al., 2017). An independent and parallel randomized clinical trial (RCT) evaluating the efficacy of the second version of the app (SIMPLe + ) is currently ongoing.

However, as is the case with other e-mental health interventions, one of the main issues noted during the feasibility study was the retention of participants (Ben-Zeev et al., 2016, Hidalgo-Mazzei et al., 2016). Although an acceptable 74% retention rate was attained at 3 months, the contents of our programme are intended to be delivered across a 6 months period. Therefore, the final implementation of a potentially widely available intervention could have been compromised if retention continued to drop. Moreover, upscaling of an open platform could potentially be affected by socio-demographic, cultural and technical factors (Aranda-Jan et al., 2014, Wozney et al., 2017b).

Considering the results of our initial feasibility study, the educational nature of the platform and requests from patients’ associations and other Institutions to use an improved, modified and open version of the SIMPLe original app (i.e. SIMPLE 1.5) we decided to open the app to a wider population whilst remaining within an independent and parallel research protocol until conclusive results regarding its efficacy are available.

OpenSIMPLe is thus an implementation feasibility study using SIMPLe 1.5 aimed at evaluating the long-term retention, usability, perceived helpfulness and satisfaction among the first 201 users of the programme: a wider and more diverse population of patients with BD. Simultaneously, we set out to explore sociodemographic, self-reported clinical factors and technical factors influencing retention, while testing the system's capability in handling a larger number of users. Moreover, we explored secondary clinical outcomes related to general health and well-being among the app users.

Section snippets

The intervention: SIMPLe 1.5

The application offered to the participants in this study was an improved version of SIMPLe 1.0 (Hidalgo-Mazzei et al., 2016). Following the user-centred design approach adopted by the project (Hidalgo-Mazzei et al., 2015, McCurdie et al., 2012, Roth et al., 2014), in SIMPLe 1.5 we incorporated suggestions based on feedback received by patients during the feasibility study as well as modifications to adapt the platform for an open study. Additionally, we developed an iOS version with the same

Data analyses

Descriptive analyses were conducted to characterize the sociodemographic and clinical characteristics of the initial sample as well as retention at the end of the programme, satisfaction and perceived helpfulness of each subcomponent of the app. Participants were further classified according to the total duration of app use as either non-completers (≤ 4.99 months of use) and completers (≥ 5 months of use). The lower-threshold for month usage was of at least 5 daily tests and 2 weekly tests

Discussion

The results of this study represent the first attempt to evaluate the feasibility of offering a large-scale wide-reaching smartphone-based IBP psychoeducation programme for BD. More than 30% of the participants continued to use the programme after 6 months. Positive outcomes regarding satisfaction and usability were mainly found among completers, whereas high percentages of perceived helpfulness, well-being and general health were found among all the participants. The data collected in this

Limitations

There are several methodological and practical limitations of this work that must be noted and generalizing results should be done with caution.

First, the screening, baseline and follow-up measures were administered using exclusively self-reported online methods which impeded reaching out back participants who dropped out to collect reasons for attrition or further comments about their experience with the programme. Furthermore, the accuracy and reliability of the information provided could not

Conclusion

The attrition rates of our implementation feasibility study delivering a large-scale psychoeducational programme for BD through smartphones were significant. We found positive outcomes regarding satisfaction and usability predominantly among completers, as well as perceived helpfulness and reported benefits to well-being and general health of all participants. The only variable significantly associated with retention was older age. In addition to proving efficacy, future studies should explore

Role of funding sources

The authors of this manuscript were indirectly supported by research grants from the Spanish Ministry of Economy and Competitiveness PI14/00286 and PI15/00588 (to FC), Instituto de Salud Carlos III, Subdirección General de Evaluación y Fomento de la Investigación; Fondo Europeo de Desarrollo Regional. Unión Europea, Una manera de hacer Europa. Other sources of indirect support are a Río Hortega grant (CM15/00127) from Instituto de Salud Carlos III (to DH), a research grant from the Spanish

Authors’ contributions

DH, MR, CB, AM, EV and FC designed the protocol. DH and FC developed and maintained the project's website. SS and AG collaborated in the recruitment process. AG was in charge of giving online support to the users. AM, CB and MR gave advice during the data management and conducted the statistical analyses. DH, VN and LS prepared the first draft of the manuscript which was subsequently reviewed and improved by SS, VP, AY, EV and FC.

Conflict of interest

DH, AM, MR, EV and FC have designed the SIMPLe smartphone application mentioned in this study. The authors declare no other conflict of interests regarding this manuscript. The authors do not have any economic interests in the SIMPLe application, its use or copyrights.

Acknowledgements

The authors would like to thank all the beta testers and users of the SIMPLe 1.0 and 1.5 apps for their kind and permanent collaboration in this project. The technical development of the application software was commissioned to SODEP S.A (Asunción, Paraguay). The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in

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