APP: Mental Health Intervention Model for Healthcare Workers

NCT06650449 | Completed

• 1 other identifier: LIDE-2022-001
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorders; Anxiety Disorders; Mental Health

Outcome Measures

Primary Outcomes (2)

• PHQ-9 (Patient Health Questionnaire)

  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.

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

• GHQ-12 (General Health Questionnaire)

  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

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

Study Arms (2)

Intervention Group (Mobile App-Based Mental Health Support)

EXPERIMENTAL

Participants in this group will use a mobile app designed to deliver cognitive-behavioral therapy (CBT) techniques over a 3-month period. The app provides 12 weekly tasks aimed at reducing emotional distress and depressive symptoms. Tasks include exercises on emotional regulation, coping strategies, and mindfulness. Progress is tracked via the app, and participants will complete the PHQ-9 and GHQ-12 questionnaires at the start and end of the intervention.

Other: Mobile App-Based Mental Health Support

Control Group (No Intervention)

NO INTERVENTION

Participants in this group will not receive any mental health intervention during the study period. They will complete the PHQ-9 and GHQ-12 questionnaires at the start and end of the 3-month period to assess changes in emotional distress and depressive symptoms for comparison with the intervention group.

Interventions

Mobile App-Based Mental Health Support OTHER

This intervention uses a mobile application designed to deliver Cognitive Behavioral Therapy (CBT) techniques. The app provides 12 weekly tasks aimed at reducing emotional distress and depressive symptoms in healthcare workers. Tasks include exercises on emotional regulation, coping strategies, and mindfulness. Participants receive notifications to encourage task completion, and the app tracks progress over the 3-month period. At the start and end of the study, participants will complete the PHQ-9 and GHQ-12 questionnaires to assess their mental health status.

Intervention Group (Mobile App-Based Mental Health Support)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Labora: lead

Study Sites (1)

UEES

Samborondón, Ecuador

Location

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Model Details: The study follows a case-control interventional model. Participants are divided into two groups: an intervention group using a mobile app based on Cognitive Behavioral Therapy (CBT) techniques, and a control group receiving no intervention. The app delivers weekly tasks over a 3-month period aimed at reducing emotional distress and depressive symptoms in healthcare workers. Both groups will be assessed at the start and end of the study using the PHQ-9 and GHQ-12 questionnaires to evaluate changes in mental health. The design allows for a comparison of mental health outcomes between those who receive the app-based intervention and those who do not.

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 21, 2024
• Study Start: January 1, 2022
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)