Clinical trial NCT05113316: Mental Health Resources for Frontline Healthcare Workers
Official title: Mental Health Resources for Frontline Healthcare Workers Using the Messy Memories App
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Keywords: Mental Health in Healthcare Workers
Stress-related problems
Frontline Workers
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Complete research clinical trial (RCT) with a sample of frontline healthcare workers to examine the Messy Memories app versus treatment as usual (TAU).
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Affect Assessments with Messy Memories Apps
timeFrame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Secondary outcomes:
measure: Change in Patient Health Questionnaire (PHQ-9)
timeFrame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
measure: Change in PTSD Checklist for DSM-5 (PCL-5)
timeFrame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
measure: Life Events Checklist (LEC) for DSM-5
timeFrame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
measure: Change in The Alcohol Use Disorders Identification Test: Self-Report Version (AUDIT)
timeFrame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
measure: Change in Maslach-Burnout Inventory
timeFrame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
measure: Change in Perceived Stress Scale (PSS):
timeFrame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
measure: Change in The Connor-Davidson Resilience Scale Brief Version (CD-RISC 10)
timeFrame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
measure: How frequently is the app used
timeFrame: From baseline to week 16
measure: For how long is the app used
timeFrame: From baseline to week 16
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: 12 Executive Park
state: Georgia
Study officials:
affiliation: Emory University
name: Sheila A.M. Rauch, PhD
role: PRINCIPAL_INVESTIGATOR
References: