Feasibility of "EmoGuía" to Guide and Personalize Psychological Treatments
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- App' usability and acceptability
研究概览
简要总结
The present project aims at testing the feasibility of an app-based system called "EmoGuía" for routine outcome monitoring of adult patients with emotional disorders while they are administered a self-applied online transdiagnostic psychological intervention.
详细描述
Anxiety and depressive disorders, commonly known as emotional disorders (EDs), are the most frequent mental health problems why patients seek for medical care globally. According to recent epidemiologic studies, lifetime prevalence rates reveal that anxiety and depression disorders affect approximately an estimated 31.9% and 33.7% of people worldwide, respectively. In Spain, a nationwide study showed a prevalence of anxiety and depression disorders of 5.2% and 4.1%, approximately. Consequently, EDs lead to considerable direct and indirect economic losses for countries, as well as a great negative impact on the quality of life and overall functioning of individuals. Adding up to the previous, the current covid-19 pandemic not only has boosted the incidence of mental disorders in healthy people, but also has exacerbated emotional problems in vulnerable populations.
Encouragingly, the effectiveness of psychotherapy for the treatment of EDs, especially cognitive behavioural therapy (CBT), has been supported by a vast amount of scientific evidence. In particular, Internet-delivered CBT (iCBT), where patients sign in to a safe website to access online psychotherapeutic materials within several modules, has emerged in recent years as an effective alternative to face-to-face psychotherapy in an attempt to reduce costs, save therapists' and clients' time, bring psychological treatments closer to the population, and disseminate interventions easily. The growth of digital care has become even more obvious during the covid-19 pandemic and the associated quarantine, where great efforts have been made to adapt evidence-based treatments to a new digital format. Therefore, the current situation has become an opportunity to develop and implement promising digital interventions, which are now more sensible than ever.
To make evidence-based treatments even more accessible, extensions and innovations of CBT have been developed in recent years. The latest research supports a transdiagnostic perspective for the treatment of EDs, where cognitive-behavioural techniques are included to target different EDs altogether. Indeed, the transdiagnostic approach appears to be an effective alternative to single disorder interventions in order to address the high comorbidity rates between anxiety and depressive disorders, as well as the shared mechanisms and the overlapping symptomatology across different disorders which play an essential role in the onset and maintenance of them. In particular, the Unified Protocol (UP), a transdiagnostic extension of CBT which works on regulate emotions in a more adaptive way through different core treatment modules, has been developed for the treatment of EDs. Specifically, the UP shows promising effects not only when delivered onsite, but also online, which makes it an excellent psychological approach to reach a large number of individuals with a single treatment protocol.
In this line, some interesting proposals emphasize the need for a paradigm shift from randomized controlled trials that work on average towards personalized treatments that allow to focus more on the individual (to avoid what group average can mask). In particular, measurement-based care, which consists of routine patient monitoring, periodic feedback to the therapist (or both therapist and patient), and adaptation of the intervention according to such feedback appears to be a feasible option in order to adapt treatments to patients' needs. Fortunately, with the rapid growth of new technologies in our society such as mobile applications (apps), measurement-based care can be implemented more effectively as the apps can be used as support tools for the assessment of several psychological outcome variables. This procedure is commonly known as Ecological Momentary Assessment (EMA) and can help overcome some of the obstacles that traditional, retrospective face-to-face assessments hold. EMA has the potential to assess patients repeatedly and frequently over time, allows to observe fluctuations in patient outcomes, and early interventions can be administered in response to pre-set clinical alarms.
To our knowledge, studies that use technology to improve the management of emotional problems have generally opted for using apps that report on the evolution of treatment to obtain more reliable measures of the evolution of patients or, more frequently, have used different technologies such as web pages or apps to facilitate self-applied treatments based on pre-established modules. The present study goes one step further and explores not only the usefulness of the EMA by means of an app for the improvement of the assessment process of patients with emotional problems/EDs, but also the feasibility of using it to make adjustments in real time or very short-term (e.g., in weekly visits) during the psychotherapeutic process, resembling an ecological momentary intervention (EMI). Several studies have supported the use of EMA to deliver the most personalized feedback or psychological support in real life for a given patient in order to enhance psychotherapy effectiveness and facilitate tailored treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
盲法说明
Patients will be informed of the condition they have been assigned to.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years
- •showing problematic levels (one standard deviation above or below the mean) in at least one of the 9 transdiagnostic dimensions of the Multidimensional Emotional Disorders Inventory (MEDI; Osma et al., 2021; Rosellini & Brown, 2019) or having moderate-to-severe anxiety (scores ≥8) or depressive symptoms (scores ≥5), as reported in the Overall Anxiety Severity and Impairment Scale (OASIS) and the Overall Depression Severity and Impairment Scale (ODSIS) (Mira et al., 2019)
- •having the ability to read and understand Spanish
- •having a computer and a mobile phone Internet access
- •signing the online informed consent.
排除标准
- •severe mental health problems
- •high suicide risk
- •receiving psychological treatment for the same ED emotional problem targeted by our study at the same time the current study is being conducted
- •<8 in OASIS and <5 in ODSIS, or non-problematic scores in the MEDI
- •have changes and/or increases in pharmacological treatment during the study (stable medication will be accepted).
研究组 & 干预措施
App + Unified Protocol Arm
Participants at this condition will be daily monitored by the app (My Emi, Emotional Well-being) while they are administered a self-applied online transdiagnostic intervention for their emotional disorders. Alarms will be generated in the face of certain pre-set undesired events.
Therapists will receive pre-set clinical alarms in real time in the presence of relevant clinical events previously determined by the clinical staff (e.g., clinical worsening or no improvement of functionality, mood or psychological mechanisms worked in therapy). This information will be used to make clinical decisions in a short period of time (e.g., call the patient, or send additional therapeutic material by mail or through the app (momentary ecological intervention), or for its implementation during the course of psychological therapy in order to make the therapy more efficient, safe, personalized and adapted to the needs of the patient.
干预措施: My EMI, Emotional Well-being + self-applied online transdiagnostic treatment (Device)
结局指标
主要结局
App' usability and acceptability
时间窗: It will be assessed at the end of the study, after 18 weeks
My EMI, Emotional Well-being will be assessed by the System Usability Scale in order to evaluate the perception that this tool is simple to use and useful. It is composed by 10 items which are responded according to a 5-point Likert scale (1 = "completely disagree" to 5 ="completely agree").
App satisfaction
时间窗: One time once the study finishes, after 18 weeks
Satisfaction with the app and perceived burden will be evaluated using questions developed by our team and used in previous works using technology (Suso-Ribera, Castilla, Zaragozá, Ribera-Canudas, Botella, \& García-Palacios, 2018). Example items will be "To what extent are you satisfied with the app?" and "To what extent would you recommend the app?".
Feasibility of the support call and videoconference
时间窗: One time once the study finishes, after 18 weeks
We will also record the number of support calls and videoconferences made as a function of the alarms received, the response rate by patients to this supportive care, and their duration.
Adherence to the app and treatment
时间窗: One time once the study finishes, after 18 weeks
Participants' adherence to the app (response rate) will be calculated by dividing the number of the completed assessments in the app by the number of planned evaluations (percentage of daily assessments completed from the assessments prompted). Additional data will be passively collected from the online treatment platform and the app. From the online treatment, the number of modules completed and the number of tasks completed in the online intervention will be collected.
次要结局
- Multidimensional Emotional Disorders Inventory(At the beginning, at the end of the study (18 weeks after using the app) and 3 month follow-up)
- Overall Anxiety Severity and Impairment Scale(At the beginning of the study, at the end of the study (18 weeks after using the app) and 3 month follow-up)
- EMAs(Daily monitoring (10 days before the intervention begins and during treatment))
- Overall Depression Severity and Impairment Scale(At the beginning, at the end of the study (18 weeks after using the app) and 3 month follow-up)
