Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650449
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
APP Mental Health Intervention Model for Healthcare Workers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
APP Modelo De Intervención En Salud Mental En Personal Sanitario
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Intervention Model and App Features
The mobile app used in this study has been specifically designed to incorporate core components of CBT including cognitive restructuring behavioral activation and emotional regulation strategies It delivers 12 weekly tasks that participants are expected to complete over a three-month period The app has been developed with healthcare professionals in mind considering the high-demand nature of their work and their need for accessible short and impactful mental health tools
Each weekly task focuses on a different aspect of CBT and is structured to promote cognitive reframing emotional awareness and behavior change Examples of tasks include
Week 1-3 Introducing participants to the basics of CBT and guiding them in identifying negative thought patterns that contribute to emotional distress
Week 4-6 Implementing emotional regulation strategies teaching participants how to manage stress anxiety and sadness through mindfulness and relaxation techniques
Week 7-9 Engaging in behavioral activation encouraging participants to take actionable steps to improve their mood such as goal setting and increasing engagement in pleasurable activities
Week 10-12 Reinforcing coping strategies and relapse prevention techniques to help participants maintain their mental well-being after completing the program
The app features include
Interactive Tasks Participants complete guided exercises within the app that allow them to apply CBT techniques to their own experiences
Reminders and Prompts Automated notifications remind participants to complete their weekly tasks improving adherence to the intervention
Progress Tracking Participants can track their progress over time reviewing completed tasks and assessing improvements in their emotional state
Resource Library The app provides access to educational materials on stress management self-care and coping mechanisms that healthcare workers can access at their convenience
Study Design
The case-control study design allows for a robust evaluation of the apps effectiveness Participants are randomized into either the intervention group which will use the app or the control group which will not receive the app intervention during the study period This design allows for clear comparison between groups controlling for natural fluctuations in mental health that might occur over time without the intervention
The primary objective is to assess the effectiveness of the app in reducing symptoms of depression as measured by the PHQ-9 and emotional distress as measured by the GHQ-12 The secondary objectives include evaluating user engagement with the app user satisfaction and the feasibility of scaling the intervention to other healthcare settings
Implementation and Technology Integration
The mobile app will be implemented in a user-friendly manner compatible with both Android and iOS devices Participants will be provided with a secure download link and the app will include a brief tutorial to help users familiarize themselves with its features Data collected through the app including questionnaire responses and engagement metrics will be encrypted and securely transmitted to a central server for analysis ensuring participant confidentiality and compliance with data privacy regulations
To facilitate high engagement the app has been designed with busy healthcare professionals in mind offering flexibility in when and where they complete their weekly tasks The apps design also includes built-in mechanisms to identify users who may need more intensive mental health support For example if a participant reports severely elevated depression scores during any task the app will trigger an alert prompting the research team to reach out and offer additional support or referrals to mental health services
Data Collection and Analysis Plan
The primary data for this study will be collected through the PHQ-9 and GHQ-12 questionnaires administered at baseline T0 and three months post-intervention T1 These tools are internationally recognized and validated for assessing depression and emotional distress respectively In addition to self-reported mental health outcomes user engagement data such as task completion rates and time spent on the app will be automatically tracked by the app
Data will be analyzed using both descriptive and inferential statistics
Descriptive statistics will summarize baseline characteristics of the participants including age gender professional role and prior mental health diagnoses
Independent t-tests will be used to compare the mean change in PHQ-9 and GHQ-12 scores between the intervention and control groups
Multivariate logistic regression models will be employed to adjust for potential confounders such as age profession education level and prior mental health status These models will help isolate the effect of the intervention from other factors that may influence mental health outcomes
User engagement metrics will be analyzed to determine adherence to the intervention and its correlation with changes in mental health outcomes This will involve examining the relationship between app usage eg number of completed tasks and reductions in PHQ-9 and GHQ-12 scores
Ethical Considerations and Feasibility
The study protocol has been reviewed and approved by the ethics committee at Hospital León Becerra and informed consent will be obtained from all participants before their enrollment Participants will be fully informed about the studys objectives their right to withdraw at any point and the confidentiality measures in place Mental health support will be available to participants who exhibit elevated levels of distress during the study ensuring their well-being is prioritized
This study represents a critical step in assessing the feasibility and effectiveness of mHealth interventions in healthcare settings The findings will not only contribute to the understanding of digital mental health tools but also provide practical insights into how these tools can be integrated into the daily lives of healthcare professionals helping to mitigate the mental health crisis facing this population
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
Intervention Model and App Features
The mobile app used in this study has been specifically designed to incorporate core components of CBT including cognitive restructuring behavioral activation and emotional regulation strategies It delivers 12 weekly tasks that participants are expected to complete over a three-month period The app has been developed with healthcare professionals in mind considering the high-demand nature of their work and their need for accessible short and impactful mental health tools
Each weekly task focuses on a different aspect of CBT and is structured to promote cognitive reframing emotional awareness and behavior change Examples of tasks include
Week 1-3 Introducing participants to the basics of CBT and guiding them in identifying negative thought patterns that contribute to emotional distress
Week 4-6 Implementing emotional regulation strategies teaching participants how to manage stress anxiety and sadness through mindfulness and relaxation techniques
Week 7-9 Engaging in behavioral activation encouraging participants to take actionable steps to improve their mood such as goal setting and increasing engagement in pleasurable activities
Week 10-12 Reinforcing coping strategies and relapse prevention techniques to help participants maintain their mental well-being after completing the program
The app features include
Interactive Tasks Participants complete guided exercises within the app that allow them to apply CBT techniques to their own experiences
Reminders and Prompts Automated notifications remind participants to complete their weekly tasks improving adherence to the intervention
Progress Tracking Participants can track their progress over time reviewing completed tasks and assessing improvements in their emotional state
Resource Library The app provides access to educational materials on stress management self-care and coping mechanisms that healthcare workers can access at their convenience
Study Design
The case-control study design allows for a robust evaluation of the apps effectiveness Participants are randomized into either the intervention group which will use the app or the control group which will not receive the app intervention during the study period This design allows for clear comparison between groups controlling for natural fluctuations in mental health that might occur over time without the intervention
The primary objective is to assess the effectiveness of the app in reducing symptoms of depression as measured by the PHQ-9 and emotional distress as measured by the GHQ-12 The secondary objectives include evaluating user engagement with the app user satisfaction and the feasibility of scaling the intervention to other healthcare settings
Implementation and Technology Integration
The mobile app will be implemented in a user-friendly manner compatible with both Android and iOS devices Participants will be provided with a secure download link and the app will include a brief tutorial to help users familiarize themselves with its features Data collected through the app including questionnaire responses and engagement metrics will be encrypted and securely transmitted to a central server for analysis ensuring participant confidentiality and compliance with data privacy regulations
To facilitate high engagement the app has been designed with busy healthcare professionals in mind offering flexibility in when and where they complete their weekly tasks The apps design also includes built-in mechanisms to identify users who may need more intensive mental health support For example if a participant reports severely elevated depression scores during any task the app will trigger an alert prompting the research team to reach out and offer additional support or referrals to mental health services
Data Collection and Analysis Plan
The primary data for this study will be collected through the PHQ-9 and GHQ-12 questionnaires administered at baseline T0 and three months post-intervention T1 These tools are internationally recognized and validated for assessing depression and emotional distress respectively In addition to self-reported mental health outcomes user engagement data such as task completion rates and time spent on the app will be automatically tracked by the app
Data will be analyzed using both descriptive and inferential statistics
Descriptive statistics will summarize baseline characteristics of the participants including age gender professional role and prior mental health diagnoses
Independent t-tests will be used to compare the mean change in PHQ-9 and GHQ-12 scores between the intervention and control groups
Multivariate logistic regression models will be employed to adjust for potential confounders such as age profession education level and prior mental health status These models will help isolate the effect of the intervention from other factors that may influence mental health outcomes
User engagement metrics will be analyzed to determine adherence to the intervention and its correlation with changes in mental health outcomes This will involve examining the relationship between app usage eg number of completed tasks and reductions in PHQ-9 and GHQ-12 scores
Ethical Considerations and Feasibility
The study protocol has been reviewed and approved by the ethics committee at Hospital León Becerra and informed consent will be obtained from all participants before their enrollment Participants will be fully informed about the studys objectives their right to withdraw at any point and the confidentiality measures in place Mental health support will be available to participants who exhibit elevated levels of distress during the study ensuring their well-being is prioritized
This study represents a critical step in assessing the feasibility and effectiveness of mHealth interventions in healthcare settings The findings will not only contribute to the understanding of digital mental health tools but also provide practical insights into how these tools can be integrated into the daily lives of healthcare professionals helping to mitigate the mental health crisis facing this population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None