CUIDA-TE, an APP for the Emotional Management of the Healthcare Professionals
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Emotional Distress
- Sponsor
- University of Valencia
- Enrollment
- 340
- Locations
- 1
- Primary Endpoint
- Assess change in Emotion Regulation Questionnaire (ERQ)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Assess change in Emotion Regulation Questionnaire (ERQ)
Time Frame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
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 Brief Patient Health Questionnaire Mood Scale (PHQ-9)
Time Frame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
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 Brief Resilience Scale (BRS)
Time Frame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
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
Time Frame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
Three items for assessing burnout in medical professionals. Higher score indicate more perceived burnout.
Assess change in Difficulties in Emotion Regulation Scale (DERS)
Time Frame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
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 ProQOL-V
Time Frame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
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 change in Overall Anxiety Severity and Impairment Scale (OASIS)
Time Frame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
The OASIS is a 5-item self-report measure to assess anxiety severity and impairment
Assess in usability with the System Usability Scale
Time Frame: At 2 months (post intervention)
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.
Secondary Outcomes
- sleep quality daily item integrated in the APP mobile(During intervention process up to 2 months)
- perceived stress daily item integrated in the APP mobile(During intervention process up to 2 months)
- Joy daily item integrated in the APP mobile(During intervention process up to 2 months)
- Sadness daily item integrated in the APP mobile(During intervention process up to 2 months)
- anger daily item integrated in the APP mobile(During intervention process up to 2 months)
- burnout daily item integrated in the APP mobile(During intervention process up to 2 months)
- Fatigue daily item integrated in the APP mobile(During intervention process up to 2 months)
- Anxiety daily item integrated in the APP mobile(During intervention process up to 2 months)
- self-perception of coping skills daily item integrated in the APP mobile(During intervention process up to 2 months)
- sleep quantity daily item integrated in the APP mobile(During intervention process up to 2 months)