Research paperPsychoeducation in bipolar disorder with a SIMPLe smartphone application: Feasibility, acceptability and satisfaction
Introduction
The estimated prevalence of bipolar disorder (BD) in the general population is estimated to be around 2%, although this could have been underestimated due to undiagnosed cases (Fagiolini et al., 2013). Besides the well-known behavior changes during pathological mood episodes, BD has a serious impact on psychosocial functioning, cognition, quality of life and survival of those affected (Catalá-López et al., 2013). Some pharmacological treatments and adjunctive psychological interventions have shown to improve the long-term outcome of the disorder (Grunze et al., 2013, Reinares et al., 2014).
Among psychological interventions, psychoeducational programs proved to be a cost-effective approach to help patients improve adherence, regularity of habits and recognize early signs and symptoms in order to prevent episodes (Colom et al., 2009, Scott et al., 2009). However, although there is an increasing demand from patients and their relatives to receive this kind of treatments, its availability is still limited due to the costs and resources involved (Miklowitz and Scott, 2009). The implementation of psychoeducation programs require trained specialists and specialized units (Colom, 2011). Unfortunately, this combination is available only at very few centers around the globe. Moreover, from the patients' side, it requires attendance to weekly sessions during a period of about 6 months. This may limit its implementation in large countries and rural areas with long geographical distances between the patient and the care center. Besides the aforementioned challenges, tailoring these interventions to individual clinical characteristics and schedules in a cost-effective way are difficult aims yet to be addressed. For these reasons, there is an increasing need to find new efficient methods to deliver and extend psychoeducation programs to a wider population of patients with BD.
During the last fifteen years, several projects have explored the possibility of delivering psychoeducation programs through Internet-based platforms such as web-sites and mobile devices (Cosgrove et al., 2013, Depp et al., 2014, Meiser et al., 2013). These platforms offer the patients the possibility to access the program according to their schedules even if they live in remote areas, something which represents a very attractive complement to the standard treatment (Holländare et al., 2015, Palmier-Claus et al., 2013, Parmanto et al., 2013). Studies evaluating these programs have shown good to acceptable retention rates of about 50–80%; however, due to the extreme heterogeneity in outcome measures and methodologies used, it is still not possible to draw sound conclusions about their long-term efficacy (Hidalgo-Mazzei et al., 2015a).
On the other hand, the wide availability, constant miniaturization and increasing computing power of mobile devices make it possible to obtain a reliable and continuous collection of relevant users´ information at a low-cost. Smartphones, through the increasing embedded sensors and daily usage patterns, can collect a vast amount of objective information to identify behavioral symptoms patterns as well as physiological signs, which have the potential to provide novel insights about mental illnesses (Munk-Jørgensen et al., 2014). Moreover, this still underutilized kind of data have recently shown to be a feasible potential biomarker of illness activity in BD (Faurholt-Jepsen et al., 2015, Faurholt-Jepsen et al., 2014).
Based on an increasing number of studies, it seems that smartphones technology is perceived by the patients as a comfortable, time-unconstrained, user-friendly and non-invasive method in the self-management of their mental health (Bush et al., 2013). Furthermore, it makes possible to register and monitor relevant signs and symptoms in real-time (Faurholt-Jepsen et al., 2015). In addition, it can provide continuous self-managed psychoeducational contents, which can be tailored to the specific needs of each individual based on their smartphone data (Ben-Zeev et al., 2013, Torous et al., 2015).
As an initial phase of the SIMPLe project (Hidalgo-Mazzei et al., 2015a), we initially set out to develop a smartphone application (SIMPLe 1.0) collecting information about potential bipolar symptomatology (i.e. subjective information), with the additional advantage of offering personalized psychoeducation messages and alerts delivered to the patient. The application is intended to be an additional tool to the usual treatment. Before testing its efficacy and due to the novelty of the intervention, it is mandatory to carry out a rigorous feasibility study in a real-world clinical setting in order to ensure the acceptability, satisfaction and safety of these interventions and increase the chances of reaching some degree of engagement in the long term (Bowen et al., 2009, Wenze et al., 2014).
Accordingly, the main aims of this feasibility study were to evaluate, during 3 months, acceptability, safety and satisfaction of the SIMPLe smartphone application designed to monitor symptoms in BD, offering customized embedded psychoeducation contents and empowering self-management. Secondary objectives were to explore whether sociodemographic and clinical variables of the sample could predict or enhance the usage of this application. Additionally, patients' suggestions and comments regarding the application were collected during the study in order to improve further versions.
Section snippets
Participants, procedure and measures
The study was conducted from March to August 2015. Participation in the study was proposed to a consecutive sample of adult patients attending the outpatient mental health clinic of the Bipolar Disorders Program in the Hospital Clínic of Barcelona. The eligibility criteria included a diagnosis of a BD type I, II or not elsewhere specified (NES) based on DSM-5 criteria. The study was approved by the Ethics Committee of the Hospital Clínic of Barcelona and registered at clinicaltrials.gov
Sociodemographic and clinical characteristics of the sample
Out of 85 individuals offered to participate in the study, 51 were initially enrolled. A flowchart of the study is depicted in Fig. 3, including the main reasons of refusal to participate from the 34 eligible non-participants. Non-participants had a mean age of 44.5 years (standard deviation, SD=12.9) and there was a predominance of women (69.4%). Two patients accepted to participate but never installed the application, hence these users were not considered in the analyses.
The baseline
Discussion
To our knowledge, this is the first study to evaluate the feasibility of mood monitoring and providing personalized psychoeducation in BD through a smartphone application independently of a face-to-face psychoeducational program. The results confirm that this particular intervention is feasible and represent a satisfactory and acceptable instrument for self-management of BD as an add-on to the usual treatment. Furthermore, the ecological momentary assessments embedded in the application,
Limitations
Several limitations from both the intervention and the study methodology have to be considered. Taking into account the nature of the intervention, results could have been influenced by the so-called “technological generation gap”. However, given the very similar mean ages between participants and non-participants as well as completers and non-completers, this does not seem to have been a crucial issue in our study. In terms of the application, it was only available for Google™'s Android
Conclusions
Despite the aforementioned limitations, SIMPLe 1.0 has proven to be a feasible intervention that, if it proves its prophylactic effects, may extend the options to offer evidence-based psychoeducation for BD regardless of their sex, age or functional status. However, its efficacy and effectiveness as an add-on treatment still needs to be evaluated in randomized controlled clinical trials. Finally, this study is an example of technology use for healthcare improvement. These initiatives may give
Role of funding source
This project was supported by research grants from the Spanish Ministry of Economy and Competitiveness PI14/00286 and PI15/00588, 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” (to FC and JS). Other sources of indirect support are a Río Hortega grant (CM15/00127) from Instituto de Salud Carlos III (to DH), a Beatriu de Pinós grant from Secretaria d’ Universitats I
Contributors and Acknowledgments
Diego Hidalgo-Mazzei, Ainoa Mateu and Francesc Colom designed the study protocol. Diego Hidalgo-Mazzei, Cristina Varo, María Reinares and Marc Valentí conducted the recruitment and enrollment of the patients. Diego Hidalgo-Mazzei and Caterina del Mar Bonnín conducted the statistical analysis. Diego Hidalgo-Mazzei, María Reinares, Andrea Murru, Ainoa Mateu and Juan Undurraga wrote the first draft of the manuscript. Afterwards, Sergio Strejilevich, José Sánchez-Moreno, Eduard Vieta and, finally,
Conflict of Interest
DH, AM, MR, EV and FC have designed the SIMPLe smartphone application mentioned in this manuscript. The authors declare no other conflict of interests regarding this manuscript. The authors do not have any current or future economic interest in the SIMPLe application, its use or copyrights.
References (61)
- et al.
A comparative psychometric study of the Spanish versions with 6, 17, and 21 items of the hamilton depression rating scale
Med. Clin.
(2003) - et al.
Clinical and neurocognitive predictors of functional outcome in bipolar euthymic patients: a long-term, follow-up study
J. Affect. Disord.
(2010) - et al.
How we design feasibility studies
Am. J. Prev. Med.
(2009) - et al.
Brief psychoeducation for bipolar disorder: impact on quality of life in young adults in a 6-month follow-up of a randomized controlled trial
Psychiatry Res.
(2014) - et al.
The increasing burden of mental and neurological disorders
Eur. Neuropsychopharmacol.
(2013) - et al.
Spanish version of a scale for the assessment of mania: validity and reliability of the young mania rating scale
(2002) - et al.
Subthreshold symptoms and time to relapse/recurrence in a community cohort of bipolar disorder outpatients
J. Affect. Disord.
(2012) - et al.
Prevalence, chronicity, burden and borders of bipolar disorder
J. Affect. Disord.
(2013) - et al.
Internet-based psychological interventions for bipolar disorder: Review of the present and insights into the future
J. Affect. Disord.
(2015) - et al.
New treatment guidelines for acute bipolar depression: a systematic review
J. Affect. Disord.
(2011)
New treatment guidelines for acute bipolar mania: a critical review
J. Affect. Disord.
Effects of adjunctive peer support on perceptions of illness control and understanding in an online psychoeducation program for bipolar disorder: a randomised controlled trial
J. Affect. Disord.
Psychosocial interventions in bipolar disorder: what, for whom, and when
J. Affect. Disord.
Practical considerations in the design and development of smartphone apps for behavior change
J. Context. Behav. Sci.
A web-based self-management intervention for bipolar disorder “living with bipolar”: a feasibility randomised controlled trial
J. Affect. Disord.
An online randomised controlled trial to assess the feasibility, acceptability and potential effectiveness of “Living with Bipolar”: a web-based self-management intervention for bipolar disorder: trial design and protocol
Contemp. Clin. Trials
A web-based preventive intervention program for bipolar disorder: outcome of a 12-month randomized controlled trial
J. Affect. Disord.
Smartphones for smarter delivery of mental health programs: a systematic review
JITA-J. Inf. Technol. Appl.
An introduction to gamification: adding game elements for engagement
Med. Ref. Serv. Q.
Behavioral screening measures delivered with a smartphone app: psychometric properties and user preference
J. Nerv. Mental Dis.
Keeping therapies simple: psychoeducation in the prevention of relapse in affective disorders
Br. J. Psychiatry
Psychoeducation efficacy in bipolar disorders: beyond compliance enhancement
J. Clin. Psychiatry
Group psychoeducation for stabilised bipolar disorders: 5-year outcome of a randomised clinical trial
Br. J. Psychiatry
Augmenting psychoeducation with a mobile intervention for bipolar disorder: a randomized controlled trial
J. Affect. Disord.
Ecological momentary assessment of mood disorders and mood dysregulation
Psychol. Assess.
Daily electronic monitoring of subjective and objective measures of illness activity in bipolar disorder using smartphones¿ the MONARCA II trial protocol: a randomized controlled single-blind parallel-group trial
BMC Psychiatry
Smartphone data as an electronic biomarker of illness activity in bipolar disorder
Bipolar Disord.
The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the biological treatment of bipolar disorders: update 2012 on the long-term treatment of bipolar disorder
World J. Biol. Psychiatry
Cited by (84)
Consumer attitudes and preferences toward psychiatric genetic counselling and educational resources: A scoping review
2024, Patient Education and CounselingDeep brain stimulation and digital monitoring for patients with treatment-resistant schizophrenia and bipolar disorder: A case series
2023, Revista de Psiquiatria y Salud MentalThe role of childhood trauma, obesity and inflammatory biomarkers in the adherence to a digital intervention among bipolar disorder outpatients: A cluster analyses
2022, Journal of Affective Disorders ReportsmHealth technology to assess, monitor and treat daily functioning difficulties in people with severe mental illness: A systematic review
2022, Journal of Psychiatric ResearchResearch progress of mobile application in disease self-management of patients with bipolar disorder
2023, Chinese Journal of Nursing