Mental HealthMessy-MemoriesNCT05113316
Mental Health Resources for Frontline Healthcare Workers
A study testing Messy Memories App in people with Mental Health, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Mental Health
- What is being tested?
- Messy Memories App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2022to 26 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mental Health Resources for Frontline Healthcare Workers Using the Messy Memories App
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.
Read the 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.
- Conditions
- Mental Health
- Being tested
- Messy Memories App
- Keywords
- Mental Health in Healthcare Workers, Stress-related problems, Frontline Workers
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Messy Memories AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Messy Memories App Group | Experimental | 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. Receives: Behavioral: Messy Memories App |
| Treatment as usual (TAU) Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Secondary outcomes (9)
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
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: From baseline to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start6 Jun 2022
- Primary completion26 May 2024
- Study completion26 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheila Rauch, Emory University
- Investigators
- Sheila A.M. Rauch, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113316
- Sponsor's protocol ID
- STUDY00003287
- Acronym
- Messy-Memories
- Status last verified
- Apr 2025
- First submitted
- 1 Nov 2021
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Resources for Frontline Healthcare Workers Using the Messy Memories App
- ClinicalTrials.gov ID
- NCT05113316
- Acronym / sponsor ID
- Messy-Memories / STUDY00003287
- Conditions
- Mental Health
- Keywords
- Mental Health in Healthcare Workers, Stress-related problems, Frontline Workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 26 May 2024 (actual)
- Study completion
- 26 May 2024 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Messy Memories App Group | Experimental | Behavioral: Messy Memories AppSubjects 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. |
| Treatment as usual (TAU) Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Messy Memories AppThe 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. | Behavioural | Messy Memories App Group |
Primary outcome
Change in Affect Assessments with Messy Memories Apps
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
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
9 secondary outcomes
Change in Patient Health Questionnaire (PHQ-9)
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in PTSD Checklist for DSM-5 (PCL-5)
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Life Events Checklist (LEC) for DSM-5
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)
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Maslach-Burnout Inventory
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Change in Perceived Stress Scale (PSS):
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)
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
How frequently is the app used
Time frame: From baseline to week 16
For how long is the app used
Time frame: From baseline to week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheila A.M. Rauch, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Messy Memories App in people with Mental Health, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Affect Assessments with Messy Memories Apps (time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.