Skip to main content
Clinical Trials/NCT06650449
NCT06650449CompletedNot Applicable

APP: Modelo De Intervención En Salud Mental En Personal Sanitario

Labora1 site in 1 country168 target enrollmentStarted: January 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
168
Locations
1
Primary Endpoint
PHQ-9 (Patient Health Questionnaire)

Study Overview

Brief Summary

This study, titled "APP: Mental Health Intervention Model for Healthcare Workers," aims to evaluate the effectiveness of a mobile app-based intervention to reduce emotional distress and symptoms of depression among healthcare workers at Hospital León Becerra in Milagro, Ecuador. The app, designed with cognitive-behavioral techniques, offers weekly tasks to improve mental health over a three-month period. The study follows a case-control design, with initial and follow-up evaluations using the PHQ-9 and GHQ-12 questionnaires to assess mental health status. The expected outcome is a significant reduction in emotional distress and depression symptoms among the participants.

Detailed Description

Detailed Description:

This study, titled "APP: Mental Health Intervention Model for Healthcare Workers," seeks to evaluate a novel mobile app-based intervention aimed at addressing mental health challenges among healthcare professionals at Hospital León Becerra in Milagro, Ecuador. The intervention leverages Cognitive Behavioral Therapy (CBT) techniques to mitigate emotional distress and reduce symptoms of depression. This approach offers a scalable, flexible, and low-cost solution to support mental well-being in healthcare environments, particularly in response to the increased psychological strain caused by the COVID-19 pandemic.

Study Rationale and Theoretical Framework:

Healthcare workers are often exposed to stressors that lead to cumulative mental health burdens, including extended working hours, emotional labor, and the pressure of making life-or-death decisions in real time. The added impact of the pandemic has exacerbated these stressors, leading to a rise in reported cases of burnout, anxiety, and depression. In resource-limited settings, where access to mental health services is often restricted due to logistical, financial, or cultural barriers, mobile health (mHealth) interventions offer a promising solution.

The intervention model of this study is grounded in Cognitive Behavioral Therapy (CBT), a well-established psychotherapeutic approach with a strong evidence base for treating depression and anxiety. CBT works by helping individuals identify and challenge negative thought patterns, develop emotional regulation techniques, and engage in behaviors that improve mood and well-being. In digital form, CBT maintains its efficacy and can be delivered asynchronously, making it ideal for busy healthcare workers who need flexibility in how and when they access mental health support.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Must be a healthcare worker (doctor, nurse, therapist, etc.) employed at Hospital León Becerra in Milagro, Ecuador.
  • Must have been working at the hospital for at least 12 months. Aged 18 years or older. Willing to participate in the study and able to provide informed consent.

Exclusion Criteria

  • Healthcare workers on leave, incapacity, or vacation during the study period. Those who do not wish to participate in the study. Individuals who no longer work at Hospital León Becerra.

Outcomes

Primary Outcomes

PHQ-9 (Patient Health Questionnaire)

Time Frame: 3 months (at baseline and after completion of the 12-week intervention).

The PHQ-9 (Patient Health Questionnaire-9) is a widely used, brief self-administered tool for screening, diagnosing, monitoring, and measuring the severity of depression. It is based on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM) and includes nine items that reflect the core symptoms of depression. Each of the nine items corresponds to a symptom of depression, and respondents are asked to rate how often they have been bothered by each symptom over the past two weeks. The response options are: 0: Not at all 1. Several days 2. More than half the days 3. Nearly every day The total score ranges from 0 to 27, with higher scores indicating more severe depression.

GHQ-12 (General Health Questionnaire)

Time Frame: 3 months (at baseline and after completion of the 12-week intervention).

GHQ-12 (General Health Questionnaire-12) with Likert Scoring The GHQ-12 with Likert scoring is designed to assess the level of psychological distress by assigning a numerical value to each response on a 4-point scale. This method allows for more nuanced analysis of the severity of mental health issues, rather than just categorizing them as "present" or "absent" as in the bimodal scoring method. Likert Scoring Scale: For each of the 12 items, responses are scored as follows: 0: Not at all 1. No more than usual 2. Rather more than usual 3. Much more than usual This creates a continuous scale where the total score can range from 0 to 36, with higher scores indicating more severe distress. Example Items and Scoring: Have you recently been able to concentrate on whatever you're doing? Not at all (0) No more than usual (1) Rather more than usual (2) Much more than usual (3) Have you recently lost much sleep over worry? Not at all (0) No more than usual (1) Rather more than usual (2) Mu

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Labora
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marco Antonio Faytong Haro

Research Professor

Universidad de Especialidades Espiritu Santo

Study Sites (1)

Loading locations...

Similar Trials