CUIDA-TE, an APP for the Emotional Management

NCT04958941 | Completed DMC

• 1 other identifier: UValencia_RCT_CUIDATE
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Distress; Burnout, Professional; Emotional Stress

Outcome Measures

Primary Outcomes (8)

• 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).

  Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)

• 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).

  Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)

• 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.

  Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)

• 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).

  Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)

• Assess change in Burnout

  Three items for assessing burnout in medical professionals. Higher score indicate more perceived burnout.

  Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)

• 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.

  Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)

• 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.

  At 2 months (post intervention)

• 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

  Change from baseline(PRE), at 2 months (post intervention)and at 3 months (follow-up)

Secondary Outcomes (10)

• Joy 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

• Sadness 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

• anger daily item integrated in the APP mobile

  During intervention process up to 2 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Experimental: Intervention group

Control group

NO INTERVENTION

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.

Interventions

Experimental: Intervention group 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.

Also known as: CUIDA-TE APP

Intervention group

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to be a healthcare worker in active (from 18 until 67 years)
• to have a smartphone with Internet access and Android operating system.

You may not qualify if:

• to be in psychological treatment at the time of the recruitment

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Related Publications (1)

• 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.

  PMID: 35248015 DERIVED

Related Links

• CUIDA-TE APP

MeSH Terms

Conditions

Burnout, Professional; Stress, Psychological

Condition Hierarchy (Ancestors)

Occupational Stress; Occupational Diseases; Burnout, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Diana Castilla, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: July 12, 2021
• Study Start: November 14, 2022
• Primary Completion: April 30, 2023
• Study Completion: July 31, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)