Feasibility of "EmoGuía" to Guide and Personalize Psychological Treatments

NCT05109780 | Not Yet Recruiting

• 1 other identifier: EMIUJI
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Emotional Disorder

Keywords

My EMI, Emotional Wellbeing; Transdiagnostic approach; Emotional Disorder; Unified Protocol

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• 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

• 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

• Multidimensional Emotional Disorders Inventory

  At the beginning, 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)

Study Arms (1)

App + Unified Protocol Arm

EXPERIMENTAL

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.

Device: My EMI, Emotional Well-being + self-applied online transdiagnostic treatment

Interventions

My EMI, Emotional Well-being + self-applied online transdiagnostic treatment DEVICE

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.

Also known as: My EMI, Emotional Well-being

App + Unified Protocol Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• age \<18
• 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).

Sponsors & Collaborators

• Universitat Jaume I: lead

Related Publications (6)

• 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.

  PMID: 29659375 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 32370140 BACKGROUND

• 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.

  PMID: 31961174 BACKGROUND

• Gual-Montolio P, Suso-Ribera C, Garcia-Palacios A, Castilla D, Zaragoza I, Breton-Lopez J. Enhancing Internet-based psychotherapy for adults with emotional disorders using ecological momentary assessments and interventions: Study protocol of a feasibility trial with "My EMI, Emotional Well-being" app. Internet Interv. 2023 Jan 5;31:100601. doi: 10.1016/j.invent.2023.100601. eCollection 2023 Mar.

  PMID: 36686334 DERIVED

Study Officials

• Patricia Gual- Montolio

  Universitat Jaume I

  STUDY CHAIR

• Juana Maria Bretón-López

  Universitat Jaume I

  STUDY CHAIR

Central Study Contacts

Carlos Suso-Ribera, Ph.D.

CONTACT

964 387643; susor@uji.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients will be informed of the condition they have been assigned to.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One condition

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: November 5, 2021
• Study Start: March 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: April 30, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share