CUIDA-TE, an APP for the Emotional Management

NCT ID: NCT04958941

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-14

Study Completion Date

2023-07-31

Brief Summary

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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

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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.

Conditions

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Emotional Distress Burnout, Professional Emotional Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

Experimental: Intervention group

Intervention Type BEHAVIORAL

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.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experimental: Intervention group

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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CUIDA-TE APP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diana Castilla, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Locations

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University of Valencia

Valencia, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 35248015 (View on PubMed)

Related Links

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Other Identifiers

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UValencia_RCT_CUIDATE

Identifier Type: -

Identifier Source: org_study_id

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