NCT05113316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

June 6, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2024

Completed
Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

November 1, 2021

Last Update Submit

April 18, 2025

Conditions

Keywords

Mental Health in Healthcare WorkersStress-related problemsFrontline Workers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Change in Patient Health Questionnaire (PHQ-9)

    At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

  • Change in PTSD Checklist for DSM-5 (PCL-5)

    At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

  • Life Events Checklist (LEC) for DSM-5

    At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

  • Change in The Alcohol Use Disorders Identification Test: Self-Report Version (AUDIT)

    At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

  • Change in Maslach-Burnout Inventory

    At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

  • +4 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Messy Memories App Group

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

12 Executive Park

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Sheila A.M. Rauch, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Complete research clinical trial (RCT) with a sample of frontline healthcare workers to examine the Messy Memories app versus treatment as usual (TAU).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 1, 2021

First Posted

November 9, 2021

Study Start

June 6, 2022

Primary Completion

May 26, 2024

Study Completion

May 26, 2024

Last Updated

April 23, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

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.

Locations