CUIDA-TE, an APP for the Emotional Management

University of Valencia

Status: Completed

Conditions: Emotional Stress; Burnout, Professional; Emotional Distress

Treatments: Behavioral: Experimental: Intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT04958941

UValencia_RCT_CUIDATE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 340 patients

Sex: All

Ages: 18 to 67 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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340 participants in 2 patient groups

Intervention group

Experimental group

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.

Treatment:

Behavioral: Experimental: Intervention group

Control group

No Intervention group

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.