Mental Health Resources for Frontline Healthcare Workers

Mental Health Clinical Trial

— Messy-Memories  

Official title:

Mental Health Resources for Frontline Healthcare Workers Using the Messy Memories App

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05113316
• Other study ID #: STUDY00003287
• Status: Completed
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: May 26, 2024

Study information

• Verified date: June 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study is designed to test and optimize the Messy Memories mobile application as an intervention. The Messy Memories mobile intervention is designed to target stress-related problems based on practices with proven effectiveness. By utilizing a mobile application intervention, this study aims to overcome barriers and provide access to evidence-informed intervention strategies that will likely improve mental health in frontline healthcare workers.

Description:

A previous Phase I of this study aimed to test usability (Phase I) of the mobile application. Following this Phase I, this current study Phase II is aimed to test effectiveness of the mobile application ("Messy Memories") in frontline healthcare workers at Emory. Considering current increases in mental health concerns and shortage of mental healthcare providers, the Messy Memories app was designed to target stress-related problems and provide frontline healthcare workers easy access to a mental health intervention that is evidence-informed.

The population to be studied includes adults (ages 18-89 years) employed at Emory Healthcare/University in Atlanta, Georgia. Potentially vulnerable participants that will be enrolled include pregnant women.

Participants will be recruited via email blast and fliers posted in clinics at Emory. These postings will include an electronic link that the potential participant can use to contact the study staff. Informed consent for Phase I will be obtained via online survey, and for Phase II informed consent will be obtained in written form (electronical consent document). This is a minimal risk and contact-less study.

The data collected is not publicly available. Data that is collected as part of this study will be de-identified before use in any analysis or publication. Research study staff will have access to participant names and contact information for the duration of their study participation for compensation purposes. Only members of the research study staff will have access to the code that links identifiers to subjects. Privacy of existing data is not a concern for this study. No HIPAA waiver is needed for this study.

Contact with participants will occur solely electronically via electronic surveys (in REDCap), emails, phone, and focus group (group discussion) via Zoom. Participants will be able to complete study tasks at any remote location that is most convenient for them. Participants will be advised to complete study tasks in the app in a private space. General scope of topics areas includes stress, depression, anxiety, traumatic experiences, burnout, wellbeing, and health behaviors.

Phase I participants will be expected to spend approximately 2 hours on study tasks, not including app use. Time spent on app use (during 2 weeks) will be at the discretion of the participant. Phase II participants will be expected to spend approximately 5 hours on study tasks, also not including app use which will be at the participant's discretion (during 16 weeks).

A participant will be identified throughout the central database by his or her unique subject identification number (SID). All research information will be stored in password-protected folders on secure and HIPAA-compliant servers that can only be accessed by the study staff and non-Emory co-investigators who sign Data Use Agreements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 26, 2024
• Est. primary completion date: May 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Participants will be male and female frontline healthcare employees between ages of 18 and 89.

• Participants must be employed at Emory Healthcare/University

• Participants must comprehend his or her role in the study and the risks involved in

Exclusion Criteria:

• Not fluent in English language

• Individuals who identify concerns that indicate high risk for suicide or self-harm behaviors

• Individuals who deny any stressful or traumatic experiences in their lifetime

• Adults unable to consent

• Individuals who are not yet adults (infants, children, teenagers)

• Prisoners

• Cognitively impaired or Individuals with Impaired Decision-Making Capacity

• Community Participation

Related Conditions & MeSH terms

• Mental Health

Intervention

Behavioral:
• Messy Memories App
The Messy Memories mobile app is an intervention targeting stress-related problems based on practices with proven effectiveness, to overcome barriers and provide access to evidence-informed intervention strategies aimed to improve mental health in frontline healthcare workers. The app allows the user to self-administer exposure therapy techniques outside of the traditional psychotherapy context. The Messy Memories app was initially released in a written form for self-help, but with widespread use of smartphones, a mobile application has the potential to further reduce barriers and increase access to care among frontline healthcare workers. The current study proposes to examine this newly developed application for usability and feasibility in a small sample of frontline healthcare workers (Phase I) and then test efficacy of the application in a larger-scale RCT (Phase II) where the application will be compared to a TAU condition.

Locations

Country	Name	City	State
United States	12 Executive Park	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Affect Assessments with Messy Memories Apps	While the participant uses the Messy Memories app, the participant will input information related to their mood over the past few days (affect rating sliders), their level of distress before and after the memory processing, answers to questions about revisiting the memory	At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Secondary	Change in Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a nine item self-report of general depression and distress. Scores are assessed by adding the columns and then multiplying the sum of the columns by 1, 2, or 3. Several studies support its validity, feasibility, and its capacity to detect changes of depressive symptoms over time	At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Secondary	Change in PTSD Checklist for DSM-5 (PCL-5)	The PCL-5 is a 20-item self-report measure designed to assess the Diagnostic and Stastistical Manual of Menatl Health's symptoms (DSM-5) of PTSD.	At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Secondary	Life Events Checklist (LEC) for DSM-5	The LEC is a 17-item self-report measure designed to inventory stressful/traumatic life events	At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Secondary	Change in The Alcohol Use Disorders Identification Test: Self-Report Version (AUDIT)	The AUDIT is a 10-item self-report measure designed to screen for problematic alcohol use (developed by the World Health Organization; WHO)	At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Secondary	Change in Maslach-Burnout Inventory	The Maslach-Burnout Inventory is a 22-item self-report measure designed to inventory burnout within the work environment as defined by the WHO.	At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Secondary	Change in Perceived Stress Scale (PSS):	The PSS is a 10-item self-report measure designed to examine frequency of thoughts and feelings related to perceived stress. The measure has been validated and widely used in the general population.	At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Secondary	Change in The Connor-Davidson Resilience Scale Brief Version (CD-RISC 10)	The CD-RISC 10 is a 10-item measure of resilience following stressful experiences	At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Secondary	How frequently is the app used	each response to a prompt within the app will be recorded with a timestamp (date and time) to indicate when the participant provided a particular response.	From baseline to week 16
Secondary	For how long is the app used	each response to a prompt within the app will be recorded with a timestamp (date and time) to indicate when the participant provided a particular response.	From baseline to week 16