Clinical trial NCT04958941: CUIDA-TE, an APP for the Emotional Management
Official title: CUIDA-TE, an APP for the Emotional Management of the Healthcare Professionals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Distress
Burnout, Professional
Emotional Stress
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Assess change in Brief Patient Health Questionnaire Mood Scale (PHQ-9)
timeFrame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
measure: Assess change in Emotion Regulation Questionnaire (ERQ)
timeFrame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
measure: Assess change in Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
measure: Assess change in Brief Resilience Scale (BRS)
timeFrame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
measure: Assess change in Burnout
timeFrame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
measure: Assess change in ProQOL-V
timeFrame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
measure: Assess in usability with the System Usability Scale
timeFrame: At 2 months (post intervention)
measure: Assess change in Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)
Secondary outcomes:
measure: Joy daily item integrated in the APP mobile
timeFrame: During intervention process up to 2 months
measure: Fatigue daily item integrated in the APP mobile
timeFrame: During intervention process up to 2 months
measure: Sadness daily item integrated in the APP mobile
timeFrame: During intervention process up to 2 months
measure: Anxiety daily item integrated in the APP mobile
timeFrame: During intervention process up to 2 months
measure: anger daily item integrated in the APP mobile
timeFrame: During intervention process up to 2 months
measure: sleep quality daily item integrated in the APP mobile
timeFrame: During intervention process up to 2 months
measure: sleep quantity daily item integrated in the APP mobile
timeFrame: During intervention process up to 2 months
measure: burnout daily item integrated in the APP mobile
timeFrame: During intervention process up to 2 months
measure: perceived stress daily item integrated in the APP mobile
timeFrame: During intervention process up to 2 months
measure: self-perception of coping skills daily item integrated in the APP mobile
timeFrame: During intervention process up to 2 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: University of Valencia
name: Diana Castilla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.