CUIDA-TE, an APP for the Emotional Management (CUIDA-TE)
Primary Purpose
Emotional Distress, Burnout, Professional, Emotional Stress
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental: Intervention group
Sponsored by
About this trial
This is an interventional prevention trial for Emotional Distress
Eligibility Criteria
Inclusion Criteria:
- to be a healthcare worker in active (from 18 until 67 years)
- to have a smartphone with Internet access and Android operating system.
Exclusion Criteria:
- to be in psychological treatment at the time of the recruitment
Sites / Locations
- University of ValenciaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
The group will receive the ecological momentary intervention (CUIDA-TE APP). This intervention will allow the individual to learn and practice adaptive ways to regulate their emotions. The protocol contains the following components: Distraction, acceptation skills, re-appraisal and problem-solving skills.
This condition is a waiting list control group with no intervention. The participants will wait for a period of 3 months. They will be offered the possibility of receiving the intervention APP (CUIDA-TE) after the waiting list period.
Outcomes
Primary Outcome Measures
Assess change in Brief Patient Health Questionnaire Mood Scale (PHQ-9)
The PHQ-9 assess depression construct and includes nine items: (1) anhedonia; (2) depressed mood; (3) trouble sleeping; (4) feeling tired; (5) change in appetite; (6) guilt, self-blame, or worthlessness; (7) trouble concentrating; (8) feeling slowed down or restless; and (9) thoughts of being better off dead or hurting oneself. PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). The PHQ-9 score is divided in the following severity categories: 5-9 (mild depression), 10-14 (modera depression), 15-19 (moderately severe depression) and 20 or greater (severe depression).
Assess change in Emotion Regulation Questionnaire (ERQ)
A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). High score indicates more likely to use this kind of emotion regulation strategies (Reappraisal Items: 1, 3, 5, 7, 8, 10; Suppression Items: 2, 4, 6, 9).
Assess change in Difficulties in Emotion Regulation Scale (DERS)
The DERS is a 36-item self-report measure of six facets of emotion regulation. Spanish validated version (Hervás & Jódar, 2008) has 28-items rated on a scale of 1 to 5. Higher scores indicate more difficulty in emotion regulation.
Assess change in Brief Resilience Scale (BRS)
The BRS is a 6-item self-report measure to assess the ability to bounce back or recover from stress. The items are rated on a 5-point scale (1 = strongly disagree; 5 = strongly agree). Range from 6 (low resilience) to 30 (high resilience).
Assess change in Burnout
Three items for assessing burnout in medical professionals. Higher score indicate more perceived burnout.
Assess change in ProQOL-V
The ProQOL (Professional Quality of Life Scale) was developed as a measure of both the negative and positive effects of working with those who have experienced traumatic stress. The ProQOL has sub-scales for compassion satisfaction, burnout, and compassion fatigue.The responses are rated on 5-point scale, indicating the frequency of each item in the last 30 days (1 = never, 2 = rarely, 3= Sometimes, 4= Often and 5 = Very Often). Higher scores on the compassion satisfaction scale represent a greater satisfaction related to the ability of the professional to be an effective caregiver in his/her job. Higher scores on the burnout scale mean a higher risk for burnout and higher scores in secondary traumatic stress indicate the professional is higher exposed to traumatic events.
Assess in usability with the System Usability Scale
The System Usability Scale (SUS; Brooke, 1996) is a reliable, 10-item questionnaire that assess the usability of a technology application. The items are rated from 1 ("Strongly disagree") to 5 ("Strongly agree"). The scale is corrected with a formula that allows to obtain scores between 0 -100 points. Unacceptable usability (with SUS scores below 50) could indicate that a user had difficulties while using the program and could be interpreted as a barrier for the clinical effect.
Assess change in Overall Anxiety Severity and Impairment Scale (OASIS)
The OASIS is a 5-item self-report measure to assess anxiety severity and impairment
Secondary Outcome Measures
Joy daily item integrated in the APP mobile
Item to assess joy/happiness daily through APP mobile. User will rate the item rating between 0 (No happiness) to 10 (Extremely happiness)
EXAMPLE ITEM:
Please, indicate the intensity of your CURRENT HAPPINESS 0= No happiness-------------------------------10= Extremely happy
Item taken from mobile APP validated in Suso-Ribera C, Castilla D, Zaragozá I, Ribera-Canudas MV, Botella C, García-Palacios A. Validity, reliability, feasibility, and usefulness of pain monitor. Clin J Pain. 2018;34(10):900-8.
Fatigue daily item integrated in the APP mobile
Item to assess Fatigue daily through APP mobile. User will rate the item rating between 0 (No Fatigue) to 10 (Extreme fatigue)
EXAMPLE ITEM:
Please, indicate the intensity of your CURRENT FATIGUE 0= No fatigue--------------------------------10= Extreme fatigue
Item taken from mobile APP validated in Suso-Ribera C, Castilla D, Zaragozá I, Ribera-Canudas MV, Botella C, García-Palacios A. Validity, reliability, feasibility, and usefulness of pain monitor. Clin J Pain. 2018;34(10):900-8.00-8.
Sadness daily item integrated in the APP mobile
Item from mobile APP validated in Suso-Ribera C, Castilla D, Zaragozá I, Ribera-Canudas MV, Botella C, García-Palacios A. Validity, reliability, feasibility, and usefulness of pain monitor. Clin J Pain. 2018;34(10):900-8.
Anxiety daily item integrated in the APP mobile
Item to assess Anxiety daily through APP mobile. User will rate the item rating between 0 (No Anxiety) to 10 (Extremely Anxious)
EXAMPLE ITEM:
Please, indicate the intensity of your CURRENT ANXIETY 0= No anxiety-----------------------------10= Extremely anxious
Item taken from mobile APP validated in Suso-Ribera C, Castilla D, Zaragozá I, Ribera-Canudas MV, Botella C, García-Palacios A. Validity, reliability, feasibility, and usefulness of pain monitor. Clin J Pain. 2018;34(10):900-8.
Item from mobile APP validated in Suso-Ribera C, Castilla D, Zaragozá I, Ribera-Canudas MV, Botella C, García-Palacios A. Validity, reliability, feasibility, and usefulness of pain monitor. Clin J Pain. 2018;34(10):900-8.
anger daily item integrated in the APP mobile
Item to assess Anger daily through APP mobile. User will rate the item rating between 0 (No Anger) to 10 (Extremely Angry)
EXAMPLE ITEM:
Please, indicate the intensity of your CURRENT ANGER 0= No anger-------------------------------10= Extremely angry
Item from mobile APP validated in Suso-Ribera C, Castilla D, Zaragozá I, Ribera-Canudas MV, Botella C, García-Palacios A. Validity, reliability, feasibility, and usefulness of pain monitor. Clin J Pain. 2018;34(10):900-8.
sleep quality daily item integrated in the APP mobile
Item to assess sleep quanlity daily through APP mobile. User will rate if the work have interfered with the quality of sleep rating between 0 (No interference) to 10 (maximum interference)
EXAMPLE ITEM:
Has WORK interfered with the quality of your SLEEP tonight? 0 = No Interference----------------------10 = Maximum Interference
Item elaborated AD HOC for this study
sleep quantity daily item integrated in the APP mobile
Item to assess sleep quantity daily through APP mobile. The user will rate the number of hours of sleep each day.
EXAMPLE ITEM:
How many hours have you slept in the last 24 hours?
Item elaborated AD HOC for this study
burnout daily item integrated in the APP mobile
Item to assess the degree of perceived burnout daily through APP mobile. User will rate the item rating between 0 (Totally disagree) to 10 (Totally agree)
EXAMPLE ITEM:
Please, indicate your degree of agreement with the next statement: "I am burned out from my work" 0= totally disagree----------------------------------------10= totally agree
Item adapted from West CP, Dyrbye LN, Sloan JA, Shanafelt TD. Single item measures of emotional exhaustion and depersonalization are useful for assessing burnout in medical professionals. JGen Intern Med. 2009; 24(12):1318-1321. https://doi.org/10.1007/s11606-009-1129-z PMID: 19802645
perceived stress daily item integrated in the APP mobile
Item to assess perceived stress daily through APP mobile. User will rate the item rating between 0 (No stress) to 10 (Extremely stressed)
EXAMPLE ITEM:
Please, indicate the intensity of your CURRENT STRESS 0= No stress------------------------------10= Extremely stressed
Item created AD HOC for this study.
self-perception of coping skills daily item integrated in the APP mobile
Item to assess perceived self-perception of coping skills daily through APP mobile.
User will rate the item rating between 0 (No capable) to 10 (Extremely capable)
EXAMPLE ITEM:
To what extent do you feel CAPABLE OF COPING with your problems right now? 0= No capable---------------------------------10= Extremely capable
Item created AD HOC for this study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04958941
Brief Title
CUIDA-TE, an APP for the Emotional Management
Acronym
CUIDA-TE
Official Title
CUIDA-TE, an APP for the Emotional Management of the Healthcare Professionals
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to develop and validate an Ecological Momentary Intervention APP for healthcare workers, in order to face of work-related stresses generated by the COVID-19 pandemic.
Detailed Description
The COVID-19 pandemic has had a very high emotional impact on healthcare workers. Ecological momentary interventions (EMI) can offer an intervention in real time, when the emotion arises. CUIDA-TE is an EMI APP based on principles of different transdiagnostic cognitive behavioral interventions focused on emotion regulation. The effectiveness of CUIDA-TE will be investigated in the current study. A two-arms randomized controlled trial (RCT) will be conducted. At least 182 healthcare workers will be randomly assigned to a 2-month immediate intervention group (CUIDA-TE APP, n= 91), or a control group (no assessment or intervention, n=91). The CUIDA-TE consists of an app-based EMI that estimates and intervenes based on ecological momentary assessment data of five emotional states: joy, fatigue, sadness, anxiety, anger, as well as sleep quality, sleep quantity, burnout, perceived stress, and self-perception of coping skills. The primary outcome is the PHQ-9. Secondary outcomes include ERQ, DERS, OASIS, BRS, SUS, and ProQOL questionnaires. Primary and secondary outcomes will be obtained at pre- and post-intervention measurements, and at 3-month follow-up measurement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Distress, Burnout, Professional, Emotional Stress
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The group will receive the ecological momentary intervention (CUIDA-TE APP). This intervention will allow the individual to learn and practice adaptive ways to regulate their emotions. The protocol contains the following components: Distraction, acceptation skills, re-appraisal and problem-solving skills.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This condition is a waiting list control group with no intervention. The participants will wait for a period of 3 months. They will be offered the possibility of receiving the intervention APP (CUIDA-TE) after the waiting list period.
Intervention Type
Behavioral
Intervention Name(s)
Experimental: Intervention group
Other Intervention Name(s)
CUIDA-TE APP
Intervention Description
During 2 months participants will be able to asses their mood and practice in real time their emotional regulation skills with an ecological momentary interventions APP.
Primary Outcome Measure Information:
Title
Assess change in Brief Patient Health Questionnaire Mood Scale (PHQ-9)
Description
The PHQ-9 assess depression construct and includes nine items: (1) anhedonia; (2) depressed mood; (3) trouble sleeping; (4) feeling tired; (5) change in appetite; (6) guilt, self-blame, or worthlessness; (7) trouble concentrating; (8) feeling slowed down or restless; and (9) thoughts of being better off dead or hurting oneself. PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). The PHQ-9 score is divided in the following severity categories: 5-9 (mild depression), 10-14 (modera depression), 15-19 (moderately severe depression) and 20 or greater (severe depression).
Time Frame
Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
Title
Assess change in Emotion Regulation Questionnaire (ERQ)
Description
A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). High score indicates more likely to use this kind of emotion regulation strategies (Reappraisal Items: 1, 3, 5, 7, 8, 10; Suppression Items: 2, 4, 6, 9).
Time Frame
Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
Title
Assess change in Difficulties in Emotion Regulation Scale (DERS)
Description
The DERS is a 36-item self-report measure of six facets of emotion regulation. Spanish validated version (Hervás & Jódar, 2008) has 28-items rated on a scale of 1 to 5. Higher scores indicate more difficulty in emotion regulation.
Time Frame
Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
Title
Assess change in Brief Resilience Scale (BRS)
Description
The BRS is a 6-item self-report measure to assess the ability to bounce back or recover from stress. The items are rated on a 5-point scale (1 = strongly disagree; 5 = strongly agree). Range from 6 (low resilience) to 30 (high resilience).
Time Frame
Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
Title
Assess change in Burnout
Description
Three items for assessing burnout in medical professionals. Higher score indicate more perceived burnout.
Time Frame
Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
Title
Assess change in ProQOL-V
Description
The ProQOL (Professional Quality of Life Scale) was developed as a measure of both the negative and positive effects of working with those who have experienced traumatic stress. The ProQOL has sub-scales for compassion satisfaction, burnout, and compassion fatigue.The responses are rated on 5-point scale, indicating the frequency of each item in the last 30 days (1 = never, 2 = rarely, 3= Sometimes, 4= Often and 5 = Very Often). Higher scores on the compassion satisfaction scale represent a greater satisfaction related to the ability of the professional to be an effective caregiver in his/her job. Higher scores on the burnout scale mean a higher risk for burnout and higher scores in secondary traumatic stress indicate the professional is higher exposed to traumatic events.
Time Frame
Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
Title
Assess in usability with the System Usability Scale
Description
The System Usability Scale (SUS; Brooke, 1996) is a reliable, 10-item questionnaire that assess the usability of a technology application. The items are rated from 1 ("Strongly disagree") to 5 ("Strongly agree"). The scale is corrected with a formula that allows to obtain scores between 0 -100 points. Unacceptable usability (with SUS scores below 50) could indicate that a user had difficulties while using the program and could be interpreted as a barrier for the clinical effect.
Time Frame
At 2 months (post intervention)
Title
Assess change in Overall Anxiety Severity and Impairment Scale (OASIS)
Description
The OASIS is a 5-item self-report measure to assess anxiety severity and impairment
Time Frame
Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
Secondary Outcome Measure Information:
Title
Joy daily item integrated in the APP mobile
Description
Item to assess joy/happiness daily through APP mobile. User will rate the item rating between 0 (No happiness) to 10 (Extremely happiness)
EXAMPLE ITEM:
Please, indicate the intensity of your CURRENT HAPPINESS 0= No happiness-------------------------------10= Extremely happy
Item taken from mobile APP validated in Suso-Ribera C, Castilla D, Zaragozá I, Ribera-Canudas MV, Botella C, García-Palacios A. Validity, reliability, feasibility, and usefulness of pain monitor. Clin J Pain. 2018;34(10):900-8.
Time Frame
During intervention process up to 2 months
Title
Fatigue daily item integrated in the APP mobile
Description
Item to assess Fatigue daily through APP mobile. User will rate the item rating between 0 (No Fatigue) to 10 (Extreme fatigue)
EXAMPLE ITEM:
Please, indicate the intensity of your CURRENT FATIGUE 0= No fatigue--------------------------------10= Extreme fatigue
Item taken from mobile APP validated in Suso-Ribera C, Castilla D, Zaragozá I, Ribera-Canudas MV, Botella C, García-Palacios A. Validity, reliability, feasibility, and usefulness of pain monitor. Clin J Pain. 2018;34(10):900-8.00-8.
Time Frame
During intervention process up to 2 months
Title
Sadness daily item integrated in the APP mobile
Description
Item from mobile APP validated in Suso-Ribera C, Castilla D, Zaragozá I, Ribera-Canudas MV, Botella C, García-Palacios A. Validity, reliability, feasibility, and usefulness of pain monitor. Clin J Pain. 2018;34(10):900-8.
Time Frame
During intervention process up to 2 months
Title
Anxiety daily item integrated in the APP mobile
Description
Item to assess Anxiety daily through APP mobile. User will rate the item rating between 0 (No Anxiety) to 10 (Extremely Anxious)
EXAMPLE ITEM:
Please, indicate the intensity of your CURRENT ANXIETY 0= No anxiety-----------------------------10= Extremely anxious
Item taken from mobile APP validated in Suso-Ribera C, Castilla D, Zaragozá I, Ribera-Canudas MV, Botella C, García-Palacios A. Validity, reliability, feasibility, and usefulness of pain monitor. Clin J Pain. 2018;34(10):900-8.
Item from mobile APP validated in Suso-Ribera C, Castilla D, Zaragozá I, Ribera-Canudas MV, Botella C, García-Palacios A. Validity, reliability, feasibility, and usefulness of pain monitor. Clin J Pain. 2018;34(10):900-8.
Time Frame
During intervention process up to 2 months
Title
anger daily item integrated in the APP mobile
Description
Item to assess Anger daily through APP mobile. User will rate the item rating between 0 (No Anger) to 10 (Extremely Angry)
EXAMPLE ITEM:
Please, indicate the intensity of your CURRENT ANGER 0= No anger-------------------------------10= Extremely angry
Item from mobile APP validated in Suso-Ribera C, Castilla D, Zaragozá I, Ribera-Canudas MV, Botella C, García-Palacios A. Validity, reliability, feasibility, and usefulness of pain monitor. Clin J Pain. 2018;34(10):900-8.
Time Frame
During intervention process up to 2 months
Title
sleep quality daily item integrated in the APP mobile
Description
Item to assess sleep quanlity daily through APP mobile. User will rate if the work have interfered with the quality of sleep rating between 0 (No interference) to 10 (maximum interference)
EXAMPLE ITEM:
Has WORK interfered with the quality of your SLEEP tonight? 0 = No Interference----------------------10 = Maximum Interference
Item elaborated AD HOC for this study
Time Frame
During intervention process up to 2 months
Title
sleep quantity daily item integrated in the APP mobile
Description
Item to assess sleep quantity daily through APP mobile. The user will rate the number of hours of sleep each day.
EXAMPLE ITEM:
How many hours have you slept in the last 24 hours?
Item elaborated AD HOC for this study
Time Frame
During intervention process up to 2 months
Title
burnout daily item integrated in the APP mobile
Description
Item to assess the degree of perceived burnout daily through APP mobile. User will rate the item rating between 0 (Totally disagree) to 10 (Totally agree)
EXAMPLE ITEM:
Please, indicate your degree of agreement with the next statement: "I am burned out from my work" 0= totally disagree----------------------------------------10= totally agree
Item adapted from West CP, Dyrbye LN, Sloan JA, Shanafelt TD. Single item measures of emotional exhaustion and depersonalization are useful for assessing burnout in medical professionals. JGen Intern Med. 2009; 24(12):1318-1321. https://doi.org/10.1007/s11606-009-1129-z PMID: 19802645
Time Frame
During intervention process up to 2 months
Title
perceived stress daily item integrated in the APP mobile
Description
Item to assess perceived stress daily through APP mobile. User will rate the item rating between 0 (No stress) to 10 (Extremely stressed)
EXAMPLE ITEM:
Please, indicate the intensity of your CURRENT STRESS 0= No stress------------------------------10= Extremely stressed
Item created AD HOC for this study.
Time Frame
During intervention process up to 2 months
Title
self-perception of coping skills daily item integrated in the APP mobile
Description
Item to assess perceived self-perception of coping skills daily through APP mobile.
User will rate the item rating between 0 (No capable) to 10 (Extremely capable)
EXAMPLE ITEM:
To what extent do you feel CAPABLE OF COPING with your problems right now? 0= No capable---------------------------------10= Extremely capable
Item created AD HOC for this study.
Time Frame
During intervention process up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
to be a healthcare worker in active (from 18 until 67 years)
to have a smartphone with Internet access and Android operating system.
Exclusion Criteria:
to be in psychological treatment at the time of the recruitment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Castilla, PhD
Phone
0034963864394
Email
Diana.Castilla@uv.es
First Name & Middle Initial & Last Name or Official Title & Degree
Irene Jaén, PhD
Phone
0034963864394
Email
Irene.Jaen@uv.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Castilla, PhD
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Castilla, PhD
Phone
0034963864394
Email
Diana.Castilla@uv.es
First Name & Middle Initial & Last Name & Degree
Irene Jaen, PhD
Phone
0034963864394
Email
Irene.Jaen@uv.es
First Name & Middle Initial & Last Name & Degree
Carlos Suso-Ribera, PhD
First Name & Middle Initial & Last Name & Degree
Maria Vicenta Navarro-Haro, PhD
First Name & Middle Initial & Last Name & Degree
Amanda Diaz-Garcia, PhD
First Name & Middle Initial & Last Name & Degree
Irene Zaragoza, PhD
First Name & Middle Initial & Last Name & Degree
Azucena Garcia-Palacios, PhD
First Name & Middle Initial & Last Name & Degree
Diana Castilla, PhD
First Name & Middle Initial & Last Name & Degree
Irene Jaén, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35248015
Citation
Castilla D, Navarro-Haro MV, Suso-Ribera C, Diaz-Garcia A, Zaragoza I, Garcia-Palacios A. Ecological momentary intervention to enhance emotion regulation in healthcare workers via smartphone: a randomized controlled trial protocol. BMC Psychiatry. 2022 Mar 5;22(1):164. doi: 10.1186/s12888-022-03800-x.
Results Reference
derived
Links:
URL
http://emi.labpsitec.es/
Description
CUIDA-TE APP
Learn more about this trial
CUIDA-TE, an APP for the Emotional Management
We'll reach out to this number within 24 hrs