Feasibility of "EmoGuía" to Guide and Personalize Psychological Treatments

Emotional Disorder Clinical Trial

Official title:

Feasibility of "EmoGuía" to Guide and Personalize Psychological Treatments

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05109780
• Other study ID #: EMIUJI
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: Universitat Jaume I
• Contact: Carlos Suso-Ribera, Ph.D.
• Phone: 964 387643
• Email: susor[@]uji.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Objectives The current study aims to explore the feasibility of an app-based system called "EmoGuía" a recently developed app that will provide personalized measurement-based care (MBC) based on EMIs according to the patients' daily evolution observed with daily evolution/assessment observed in the app (Castilla et al., 2022a). The EMI app will complement a self-applied online transdiagnostic treatment for people with EDs, which has shown to be effective in past research (Díaz-García et al., 2021).

The objectives of this feasibility study are: (1) to test whether the EMI app is appraised as simple to use, useful and acceptable by both patients and psychologists (app usability, satisfaction, and acceptability) and, (2) to test the number of completed assessments and transdiagnostic modules from those suggested (adherence to the app and treatment compliance). As a secondary goal, we will investigate the potential effectiveness of the EMI app by exploring whether changes in outcome variables and mechanisms of change (anxiety, depression, and emotion regulation) occur after the app use at an individual level.

We anticipate that the implementation of the app "EmoGuía" will be feasible in terms of usability, satisfaction, acceptability, compliance, retention rates, and adherence. Thus, we expect that patients and psychologists will perceive the app to be useful, will experience low burden associated with its use, and will be satisfied with the procedure. We also expect to improve the mood status and emotion regulation outcomes in a large number of participants.

The design of a future clinical trial will be optimized with the aforementioned objectives. The current article describes the study protocol of this trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 30, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age =18 years

2. 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)

3. having the ability to read and understand Spanish

4. having a computer and a mobile phone Internet access

5. signing the online informed consent.

Exclusion criteria:

1. age <18

2. severe mental health problems

3. high suicide risk

4. receiving psychological treatment for the same ED emotional problem targeted by our study at the same time the current study is being conducted

5. <8 in OASIS and <5 in ODSIS, or non-problematic scores in the MEDI

6. have changes and/or increases in pharmacological treatment during the study (stable medication will be accepted).

Related Conditions & MeSH terms

• Emotional Disorder
• Mood Disorders

Intervention

Device:
• My EMI, Emotional Well-being + self-applied online transdiagnostic treatment
The intervention will consist in a self-applied online transdiagnostic intervention for emotional problems together with an app-based EMI. In terms of monitoring, the My EMI, Emotional Well-being is a mobile app whose contents have been adapted to conduct ecological momentary assessments in different health conditions. The app assesses important psychological variables, namely anxiety, depressive symptoms,etc. Participants respond daily to the questions in the app. In terms of the online self-applied intervention, the Unified Protocol is a transdiagnostic extension of CBT which works on regulate emotions in a more adaptive way through 5 core treatment modules: present-focused emotional awareness, cognitive flexibility, identification and prevention of emotional avoidance patterns, increasing awareness and tolerance to emotion-elicited physical sensations, and graded (interoceptive and situational) exposure procedures.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Jaume I

References & Publications (5)

Barlow DH, Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Allen LB, Ehrenreich-May J. Protocolo unificado para el tratamiento transdiagnóstico de los trastornos emocionales: Manual del terapeuta y manual del paciente. [The unified protocol for transdiagnostic treatment of emotional disorders: Client workbook and Therapist guide]. Madrid: Alianza Editorial; 2015.

Colombo D, Fernandez-Alvarez J, Suso-Ribera C, Cipresso P, Valev H, Leufkens T, Sas C, Garcia-Palacios A, Riva G, Botella C. The need for change: Understanding emotion regulation antecedents and consequences using ecological momentary assessment. Emotion. 2020 Feb;20(1):30-36. doi: 10.1037/emo0000671. — View Citation

Gual-Montolio P, Martinez-Borba V, Breton-Lopez JM, Osma J, Suso-Ribera C. How Are Information and Communication Technologies Supporting Routine Outcome Monitoring and Measurement-Based Care in Psychotherapy? A Systematic Review. Int J Environ Res Public Health. 2020 May 2;17(9):3170. doi: 10.3390/ijerph17093170. — View Citation

Osma J, Castellano C, Crespo E, García-PalaciosA. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in format group in a Spanish public mental health setting. PsicologíaConductual. 2015; 23 (3): 447-466.

Suso-Ribera C, Castilla D, Zaragoza I, Ribera-Canudas MV, Botella C, Garcia-Palacios A. Validity, Reliability, Feasibility, and Usefulness of Pain Monitor: A Multidimensional Smartphone App for Daily Monitoring of Adults With Heterogenous Chronic Pain. Clin J Pain. 2018 Oct;34(10):900-908. doi: 10.1097/AJP.0000000000000618. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	App' usability and acceptability	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").	It will be assessed at the end of the study, after 18 weeks
Primary	Adherence to the app and treatment	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.	One time once the study finishes, after 18 weeks
Primary	App satisfaction	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?".	One time once the study finishes, after 18 weeks
Primary	Feasibility of the support call and videoconference	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.	One time once the study finishes, after 18 weeks
Secondary	Overall Anxiety Severity and Impairment Scale	It consists of 5 questions that measure the severity and interference of anxiety during the previous week (Osma et al., 2019). The total scale score ranges from 0 to 20. Items are rated on a 5-point Likert scale ranging from 0 to 4. The Spanish validation has shown excellent internal consistency estimates (Cronbach's alpha was 0.87) in patients with EDs (Osma et al., 2019).	At the beginning of the study, at the end of the study (18 weeks after using the app) and 3 month follow-up
Secondary	Overall Depression Severity and Impairment Scale	It consists of 5 questions that measure the severity and interference of depression during the previous week (Osma et al., 2019). Again, the total scale score ranges from 0 to 20. Items are rated on a 5-point Likert scale ranging from 0 to 4. The Spanish validation has shown excellent internal consistency estimates (Cronbach's alpha was 0.94) in patients with EDs (Osma et al., 2019).	At the beginning, at the end of the study (18 weeks after using the app) and 3 month follow-up
Secondary	Multidimensional Emotional Disorders Inventory	The MEDI has 49 questions grouped in 9 dimensions (Osma et al., 2021). The Spanish validation of the MEDI has shown excellent reliability indices as estimated with the internal consistency of the nine factors (Cronbach's alphas between 0.74 and 92) (Osma et al., 2021).	At the beginning, at the end of the study (18 weeks after using the app) and 3 month follow-up
Secondary	EMAs	Outcome variables (anxiety, depression, anger, happiness, activity level) and mechanisms of change (understanding role of emotions, mindfulness, cognitive flexibility, Emotional avoidance, Tolerance to unpleasant physical sensations, and Behaviours not guided by emotion)	Daily monitoring (10 days before the intervention begins and during treatment)