Ecological momentary intervention to enhance emotion regulation in healthcare workers via smartphone: a randomized controlled trial protocol

On March 11th, 2020, the WHO declared a worldwide pandemic level for a new coronavirus, the SARS-COV-2, better known by its disease name: COVID-19 [1]. This pandemic has pushed the health systems around the world, including the Spanish one, to the limit. For example, the Spanish National Institute of Statistics estimates that over 84 thousand individuals have died due to COVID-19 in Spain [2], while over 4.5 million deaths have been calculated globally.

In addition to the burden of COVID-19 on our health systems, experts and institutions around the world have increasingly claimed for the importance of this pandemic on the mental well-being of individuals [3]. The psychological side effects of the COVID-19 pandemic are vast and range from social isolation, fear of infection, marital conflicts, anxiety, post-traumatic stress, and depression, among others [4]. In particular, a group of individuals that have experienced additional burden due to their high exposure to the disease and high work-related demands are healthcare professionals. A recent literature review including 24 studies supports the idea that the psychological effects of the pandemic on healthcare workers has been devastating globally [5]. This is also the case of Spain, where at least 50% of Spanish healthcare professionals are at high risk of developing a mental disorder as a result of the stress associated with COVID-19 [6]. In particular, this study showed that 28.1% of healthcare professionals suffered from depression, 22.5% had an anxiety disorder, almost 1 in 4 suffered from panic, 22.2% had post-traumatic stress disorder, and over 6% suffered from substance abuse. In addition, a recent investigation revealed that up to 8.4% of healthcare professionals have experienced suicidal ideation during the pandemic [6].

Healthcare workers are and have been facing very severe work stressors for many months. For example, they have been fighting against a relatively unfamiliar virus, have had to work for longer hours than usual, have often faced a high work overload and significant risk of infection, have had to follow very strict safety protocols, and have been asked to remain highly concentrated and vigilant [7, 8]. Not surprisingly, burnout and fatigue have significantly increased in this population as a result of the COVID-19 crisis [9]. In this line, a study conducted at the beginning of the pandemic revealed that the most common symptoms in Spanish healthcare professionals were stress, anxiety, depression, and insomnia, which all occurred in significant levels [10]. In another large study conducted during the first wave of the COVID-19 pandemic, one in seven healthcare professionals in Spain screened positive for a disabling mental disorder, from which emotional disorders were the most frequent [11]. The findings suggested that workers frequently exposed to patients affected by COVID-19 patients or those who have been infected or quarantined/isolated should be considered groups that need special monitoring of mental health and psychological support. In addition to these problems, and similar to past epidemics, other adverse psychological reactions have also been observed, such as fear of infection, fear of contagion, fear of infecting family and friends, and uncertainty and stigmatization [12–14], which again adds to the burden of the COVID-19 pandemic.

As a result of the previous, there is growing concern about the psychological adjustment and recovery of healthcare workers who directly treat and care for patients, especially when the latter have an active infection or belong to vulnerable populations (e.g., the elderly). In particular, researchers support the idea that, if not adequately and timely addressed, the aforementioned stressors associated with patient care during the pandemic could potentially lead to the development of long-term anxiety disorders, depression, or post-traumatic stress disorder [10]. As a result, recent studies have concluded that it is necessary to offer healthcare professionals, especially those who have been more impacted by the pandemic, psychological help to reduce the emotional impact of COVID-19. Ultimately, this might not only benefit their mental health, but also it will protect and help maintain the sustainability of our healthcare systems [15–18].

In the last decade, transdiagnostic treatments have gained ground in the treatment of psychological problems, particularly anxiety and depression problems (i.e., emotional disorders, ED). Transdiagnostic treatments emphasize the need to target essential, shared mechanisms or processes that are common to a wide range of emotional problems without tailoring the protocol to specific diagnoses [19]. This is important because it allows to offer a single intervention to individuals with different emotional problems, even if they have comorbidities (i.e., more than one emotional problem).

A transdiagnostic intervention for EDs that has received particular attention in the past years is the Unified Protocol [20]. According to the UP, individuals with emotional disorders share a tendency to frequently and intensely experience negative affect and exhibit maladaptive reactions to these intense, unpleasant emotions [21, 22]. These responses to difficult emotional states are known as emotion regulation (ER) efforts and are key underlying mechanisms of psychopathology for the majority of third-wave psychological interventions, such as Dialectical Behavior Therapy (DBT [23, 24];), Acceptance Commitment Therapy (ACT [25];), and the Unified Protocol [20]. In fact, a recent systematic review [26] identified ER components across all intervention modalities and disorders, thus indicating that ER may be a transdiagnostic factor involved both in the expression and treatment of psychopathological problems. Vast evidence now supports this idea of ER as a transdiagnostic construct [27–29].

ER is a complex process that involves regulating emotional arousal and emotional expressions flexibly according to the context demands [30, 31]. Research has shown that emotion regulation strategies are associated with burnout in the professionals, so emotion regulation training is fundamental for healthcare professionals [32]. When people deal with stress, such as the one described in healthcare professionals during the COVID-19 pandemic, ER enables individuals to evaluate the emotional impact of the situation and helps them to make decisions about the most preferable emotional reactions in that situation [33]. In particular, the UP focuses on regulating negative affect by addressing emotional avoidance, promoting cognitive flexibility, facilitating exposure to avoided situations and sensations, and increasing present-focused emotional awareness [34].

Another treatment approach that includes principles or components that could be useful to target difficulties in emotion regulation is DBT. DBT is based on a skill deficit model that views dysfunctional behavior as either a consequence of dysregulated emotions or a maladaptive approach to ER [24]. DBT places a special emphasis on increasing experiential awareness and acceptance (mindfulness techniques), but it also includes behavioral strategies focused on changing emotional reactions (e.g., opposite action) [35]. This treatment has been suggested to be effective for a wide range of disorders with symptoms that are functionally similar to those of borderline personality disorder (e.g., depression, substance use disorder, anxiety disorders, and eating disorders), for which emotion dysregulation has been proposed to be the main etiological and transdiagnostic factor [35]. More recently, DBT has also been used to address emotion dysregulation in clinical and non-clinical populations [36].

Considering the aforementioned evidence of transdiagnostic interventions for ER, the treatment proposed in this study will include different strategies from the UP and DBT. An emphasis will be placed on the prevention of emotional problems that may occur due to recurrent stress in healthcare professionals. Based on the results of past research, the selection of prevention strategies targeting common transdiagnostic processes (e.g., emotional dysregulation), as opposed to separate diagnostic categories, would present a number of advantages: [1] increase treatment efficacy, because common prevention strategies targeting shared processes would replace numerous interventions targeting specific disorders, thus allowing to treat more people simultaneously with less resources [2]; reduce economic costs by using only one intervention to prevent a broad set of emotional problems [3]; and, finally, transdiagnostic prevention strategies emphasize improving individual quality of life and functioning, which might help prevent disorders before they occur [34].

While the importance of psychological help during the pandemic has been recognized, healthcare professionals appear to face important barriers and restrictions to receiving mental health support [37]. These appear to include, for example, the stigma associated with mental care, time restrictions, and lack of knowledge about the available resources for help. A recent call to action from mental health science underlines the importance of research identifying interventions that can be delivered under pandemic conditions to reduce its psychological impact, especially on vulnerable populations [38]. Self-applied, online, and brief interventions could be a workable solution in this scenario.

COVID-19 has resulted in an unprecedented acceleration and penetration of the digital world in everyday life in general and in the mental health field in particular [4], so a new era of digital interventions is expected [39]. While acknowledging this boost of information and communication technologies (ICTs) for mental care due to the COVID-19 pandemic, the use of ICTs is not new in the Psychology field. Internet-delivered interventions have demonstrated their efficacy in more than 100 controlled clinical trials [40, 41]. In the last 10 years, due to the increased availability of the Internet worldwide and its ubiquity through smartphones, a remarkable progress has been made in the field of psychological treatments with ICTs. As a result, the inclusion of technologies in psychological care has helped overcome some barriers and obstacles associated with psychological treatments, such as stigma, anonymity, economic accessibility, waiting lists, and travel restrictions, among others [42]. Self-applied, online treatments can reach the patient in a more economical and immediate way and are accessible to people who would otherwise experience difficulties when attempting to receive treatment (e.g., due to long geographic distances to health centers, limited financial resources, or lack of time). Therefore, such interventions are feasible alternatives from an economic point of view, since they allow the dissemination of evidence-based treatments at low costs [43]. Due to the advantages of self-applied, online psychological interventions, the aim of the present study is to test their efficacy and feasibility in a sample of healthcare professionals that have been in the front line of patient care during the COVID-19 pandemic.

Digital treatment platforms have advanced notably in the past years. Mobile devices, such as smartphones, are effective ways to deliver psychological interventions [44] and improve psychological assessment by minimizing problems like recall bias due retrospective assessments and the poor adherence to paper diaries [45]. In addition, mobile devices take the aforementioned advantages of online treatments one step further by opening the door of ubiquity to ICT-based psychological interventions. In particular, smartphones allow users to carry the treatments with them in their pockets, which permits clinicians to react in real or in short time when a problem is detected (e.g., if a patient does not leave the home for several days) and facilitates tailoring (i.e., personalizing) treatments to the patient needs at any given moment (e.g., a treatment component can be provided depending on the problem reported in real time) [42].

Another advantage of mobile devices is that they facilitate the assessment and treatment of ER as situational and context-related processes [46]. ER strategies are not adaptive or maladaptive per se, but dependent on the context in which they occur [47, 48]. For example, research has shown that, when the emotional intensity of a situation is low, people tend to use reappraisal [49], which is a form of cognitive change that involves reinterpreting the meaning of a potentially emotion-eliciting situation [50]. Conversely, in the context of a situation with high emotionality, distraction (that consists of disengaging attention from emotional processing by producing neutral thoughts that are independent from and not in conflict with emotional information [51]) is usually preferred [46]. A possible explanation suggested by Fruzzetti and Shenk [52] is that, when people are highly emotionally aroused, they experience poorer cognitive capacity, less self-awareness, and impaired ability to solve problems, which means that distraction may be an adaptive strategy on that specific context. There is already some evidence in this regard. For example, Sheppes et al. [53] showed that, when the intensity of emotional stimuli was low, cognitive demands were accordingly low, long-term goals were more easily activated, and individuals were more likely to implement cognitive reappraisal as an ER strategy. However, when the emotional stimuli were very intense, cognitive demands were high, short-term goals were more easily activated, and participants were keener to use distraction as a coping strategy. Overall, these findings support the view that ER strategy choice and utility is situational and context-related [46].

A common barrier to evaluating the effectiveness of psychological treatments has been related with the dynamic nature of emotional phenomena, which in a healthy individual fluctuates not only over time, but also notably within a single day [54]. To date, research regarding ER has mostly been based on laboratory experiments, which tend to rely on retrospective evaluations and leave situated and momentary aspects relatively unknown [47]. To overcome these limitations, ecological momentary assessment (EMA) has become increasingly popular in the ER research [55]. EMA, also called Experience Sampling Method (ESM), emerged in the 1980s [56, 57], but has been traditionally difficult to implement due to the limitations of paper diaries [58]. EMA requires the evaluation of individuals in the natural context and the moment (or as close as possible) in which events (e.g., an emotion) occur to increase the reliability and ecological validity of the measure obtained. EMA makes it possible to collect repeated inputs of thoughts, feelings, and behaviors close in time to the experience and in real-life contexts [47].

The popularity of EMA studies has clearly increased in the past years, arguably due to the increased availability of mobile applications [55]. EMA has been used for both subjective [58] and objective [59] data collection, and this method has already significantly increased our knowledge about ER outside laboratory settings [60]. Smartphone devices, which are now more accessible than ever [61], have shed new light into EMA and have renewed interest for this type of methodology.

In addition to EMA, smartphones facilitate Ecological Momentary Interventions (EMI), because they allow to provide psychological care to individuals in their natural environment at the time when the support is needed [62]. EMIs consist of momentary treatments provided via mobile technologies while people are engaged in their typical everyday life routines. These interventions can be used as an adjunct to existing psychological therapies delivered by a therapist or they can be implemented as a stand-alone intervention [63]. EMIs are important because they provide the patients with timely recommendations or therapeutic instructions when problems occur as opposed to time later during onsite appointments. This has been argued to reduce patient suffering, enhance treatment effectiveness, and reduce treatment costs [64, 65], which makes this a very suitable methodology to be implemented in new generation psychological treatments for EDs.

In sum, the availability and spread of smartphones has made EMA and EMI more feasible than ever. In fact, a recent systematic review into psychological interventions using mobile devices revealed an exponential growth of published studies focusing on the development of psychological treatments via smartphones [44]. This study, however, indicated that a large number of investigations have used smartphones for monitoring purposes only (EMA), while RCTs comparing different functionalities or conditions are still infrequent (15.8%). The present investigation represents a step in this direction.

As mentioned earlier, healthcare workers have been under a great deal of stress for almost 2 years due the COVID-19 pandemic. As a result, an important number of them have experienced significant levels of stress, anxiety, depression, and insomnia [10]. It is important to note, however, that healthcare workers are not necessarily clinical population with previous psychopathological problems. On the contrary, they might be mentally healthy individuals that are exposed to important chronic stressors and, as a consequence of this exceptional situation, might benefit from some psychological support for prevention purposes. As noted earlier, learning ER skills can prevent the onset of emotional disorders, their maintenance, and worsening, as well as improve the quality of life of individuals. In particular, transdiagnostic interventions focused on teaching emotion regulation skills may be good therapeutic options to teach healthcare professionals how to cope with stress [26] and burnout [32].

Because time restrictions in healthcare professionals are frequent and we aim to offer timely interventions, we propose a two-month brief intervention using smartphones. This technology allows users to receive a treatment in real/short time and facilitates the adaptation of treatments to the needs of patients at any given moment. In this study, we aim to take a step further by comparing two types of innovative interventions. More specifically, the current study will analyze the efficacy of an ecological momentary intervention (EMI) to enhance emotion regulation skills compared with an ecological momentary assessment (EMA), which might enhance awareness of emotions, and a wait-list control group (no daily monitoring nor intervention).

The EMI will be an interactive intervention allowing healthcare workers to record their emotional states at momentary periods. In addition, they will receive contextual ER strategies on request. Considering the recent research on ER strategy choice [49, 53, 66], the logic of displaying one ER strategy or another via EMI will be based on the type of emotional state and emotional intensity reported by the participant. On the other hand, because emotional awareness is a form of emotion regulation processing [66], assessing emotions daily may help improve the self-awareness of emotions, thus contributing to a better emotional regulation. Therefore, an EMA only condition will be included in this study to distinguish the effect of EMA and EMI. The EMI protocol will include different transdiagnostic cognitive behavioral interventions that will be administered to healthcare workers who are or have been recently and repeatedly exposed to COVID-19 related stress. The treatment will be administered via smartphone during 2 months. Treatment efficacy will be evaluated at post-treatment and 3 months later (follow-up). To the best of our knowledge, this is the first investigation that aims to evaluate the efficacy of an ecological, momentary, and self-administered transdiagnostic psychological intervention via smartphone for healthcare professionals during the pandemic.

The goal of this study is to evaluate the efficacy of an ecological, momentary, and self-administered transdiagnostic psychological intervention via smartphone for healthcare professionals (compared to an ecological momentary assessment group and a wait-list group) to decrease depression, difficulties in emotion regulation and increase professional quality of life and resilience. We also would like to study the usability and acceptability of the technology.

The current study will use a randomized controlled superiority trial design. A minimum of 174 healthcare workers will be randomly assigned into three conditions: (1) EMI intervention group, (2) EMA intervention group, and (3) wait-list control group. An online informed consent form will be signed by the participants before randomization. Assessments will be conducted at pre-treatment, post-treatment, and 3- month follow-up. The experimental groups will use different apps during 2 months: the experimental group (1) will use an EMI app (CUIDA-TE) and the experimental group (2) will use an EMA app (MONITOR EMOCIONAL). For ethical reasons, when the wait-list group completes the post-treatment assessment (2 months after the base-line evaluation), the EMI app will be offered if the interim analyses support this. Participants in the EMA condition will also be offered this option at the end of the 3-month follow-up, again if the results support this. The trial has been approved by the Ethics Committee of Humans Research of the Ethics Commission in Experimental Research of University of Valencia (Spain) and it has been registered in clinicaltrials.gov↗ as NCT04958941↗ (https://clinicaltrials.gov/ct2/show/NCT04958941↗). The study will adhere to the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) [67]. The design of the study is outlined in Fig. 1.

A sample of 174 healthcare workers will be recruited from the Spanish healthcare system (hospitals, primary care centers, and nurse care centers). Participants will be eligible if they meet the inclusion criteria: 1) being an active healthcare worker and 2) having an Android smartphone with Internet access. Participants will be excluded if they are already receiving a psychological treatment at the time of the recruitment or 2) having a smartphone with an operating system different to Android. Participants will be recruited from two sources: 1) volunteers from a large healthcare provider company (GESMED company, with 2.500 healthcare workers at the region) and 2) volunteers from different healthcare organizations recruited online using social media (paid campaigns) and personal contacts.

The sample size was calculated a priori using GPower [68]. Assuming a conservative effect size of 0.20, an alpha level of 0.05, an 80% power, three groups, and 3 measurements, a sample of 152 was obtained. Assuming a 15% of attrition, we will recruit a minimum of 174 participants. The small attrition rate is based on a systematic review showing that interventions for mental health that incorporate technology, such as blended interventions, tend to obtain lower dropout rates [69]. The effect size in favor of EMI compared to EMA and the control condition is also inspired by past research [70].

Two active conditions will be used in this study, that is, (1) the EMI intervention and (2) the EMA condition. Because, Android OS represents 80% of the users in Spain [89], the apps for this study have been developed only in this operating system. Further development in other mobile operative systems will be done after the results have been analyzed.

Participants will be volunteers of a healthcare provider company (GESMED) and different healthcare organizations (online recruitment). For volunteers recruited online, the call of participants will be made using an open campaign that will be disseminated via social networks (WhatsApp, Instagram, Twitter, Facebook, and LinkedIn) and personal contacts. For the GESMED volunteers, the call of participants will be done sending an internal e-mail to the workers offering the study information and the website for the study (www.cuidateapp.com↗). Interested candidates from both sources who meet the inclusion criteria will be included in the study after the informed consent is signed online. The randomization will be conducted by an independent researcher not involved in the study and qualified from clinical point of view. Participants will be allocated to one of the three conditions using a computer-generated random software (Random allocation software 2.0 [101];). After signing the consent form and once the randomization is made, the participants will know the condition in which they are allocated and will receive a brief explanation of the characteristics of their condition.

First, all users will fill the baseline questionnaires (primary and secondary outcomes) online. The first intervention group will use the CUIDA-TE app during 2 months. The second intervention group will use MONITOR EMOCIONAL app, again during 2-months. The wait-list control group will remain without treatment in a waiting list condition during 2-months. After that, they will be offered the opportunity to receive the intervention app (CUIDA-TE app) if the interim analyses support this. Primary and secondary outcomes will be measured again at post-treatment (2 months after the baseline assessment) and at follow-up (3 months).

D.C. is an Assistant Professor at the Universitat de Valencia, in the Department of Personality, Evaluation and Psychological Treatments. She works as a research member of LABPSITEC since 2005, and member of CIBERobn (Centre for Network Biomedical Research) group in the area of Biomedicine and Health Sciences, Instituto de Salud Carlos III. (www.ciberisciii.es↗).

M.V.N-H. is an Assistant Professor at the University of Zaragoza. She works as a research member of GIIS082 – Investigación en Personalidad, Emoción y Salud (IPES) at the Instituto de Investigación Sanitaria Aragón. C.S-R. is an Associate Professor at the Universitat Jaume I, and he works as a research member of LABPSITEC, and member of CIBERobn (Centre for Network Biomedical Research) group in the area of Biomedicine and Health Sciences, Instituto de Salud Carlos III. (www.ciberisciii.es↗). A.D-G. is an Assistant Professor at the University of Zaragoza. She works as a research member of GIIS082 – Investigación en Personalidad, Emoción y Salud (IPES) at the Instituto de Investigación Sanitaria Aragón.

I.Z. is a senior researcher of CIBERobn (Centre for Network Biomedical Research) group in the area of Biomedicine and Health Sciences, Instituto de Salud Carlos III. (www.ciberisciii.es↗). AG-P is a full professor of Psychopathology at the Universitat Jaume I and she is also the Director of LABPSITEC (Laboratory of Psychology and Technology, www.labpsitec.com↗) and the Head of the Psychological Assistance Service at Universitat Jaume I, recognized by the health authorities as a mental health facility.

The study follows the standards of the Declaration Helsinki and existing guidelines of Spain and the European Union for the protection of patients in clinical trials. All participants interested in participating will sign an online informed consent form. The study has been approved by the Ethics Commission in Experimental Research of University of Valencia (Spain) in May 2021 (Register code 1547727) and it has been registered in clin-icaltrials.gov↗ as NCT04958941↗ (https://clinicaltrials.gov/ct2/show/NCT04958941↗). The study will adhere to the recommendations of the Consolidated Standards of Reporting Trials (CONSORT).

“Not applicable” in this section.

The authors declare that they have no competing interests.

It is not possible to share the data because the study status is “Not yet recruiting”.