An interventional study of Messy Memories App in Mental Health, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-04-23.
Sponsored by Emory University · Not applicable, Interventional, and Prevention
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.
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.
Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will download and have access to the Messy Memories application in addition to completing self-report measures electronically at pre-determined time points. While the subject uses the 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, answers to questions in the social connection and self-care modules including assessment of, for example, sleep pattern, eating habits, and exercise habits. The Messy Memories app will also collect data on how frequently and for how long each participant uses the app. Each response will trigger a prompt within the app, and will be recorded with a timestamp (date and time) to indicate when the participant provided a particular response. For all participants, self-report measures will be collected at weeks 4, 8, 12, and 16.
Behavioral: Messy Memories App
Subjects will not receive any study treatments or have access to the app but may seek standard treatment if they choose, in addition to completing self-report measures. For 8 weeks, TAU group will participate in the study under treatment as usual. For weeks 9-16, the TAU group will then switch and have full access to the Messy Memories App to review and use for a limited amount of time. Subjects will download and have access to the Messy Memories application in addition to completing self-report measures electronically at pre-determined time points. While the subject uses the app, the participant will input information related to their mood over the past few days, their level of distress before and after the memory processing, answers to questions about revisiting the memory, answers to questions in the social connection and self-care modules including assessment of, for example, sleep pattern, eating habits, and exercise habits.
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.
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
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
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
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
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.
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Life Events Checklist (LEC) for DSM-5
The LEC is a 17-item self-report measure designed to inventory stressful/traumatic life events
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
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)
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
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.
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
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.
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
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
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
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.
Time frame: From baseline to week 16
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.
Time frame: From baseline to week 16
Plan to share: No — The results of the study will not be shared with participants at the individual level. Once the aggregate data are analyzed, participants may request the study results from the research team. A member of the research team will make these results available after the completion of the study.
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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