N/A
N=69
Messy Memories: Mobile Application Therapy Following Critical Illness
Critical Illness · Psychological Distress · Health Behavior
Bottom Line
View on ClinicalTrials.gov: NCT05849454 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Percentage of Screened Participants Who Screen Eligible for the Study — 65.22 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Messy Memories Intervention (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Screened Participants Who Screen Eligible for the Study |
65.22 | — |
| PRIMARY Percentage of Eligible Participants Who Enroll in the Study |
64.44 | — |
| PRIMARY Percentage of Enrolled Participants Who Record a Memory in the Memory Processing Module |
65.52 | — |
| PRIMARY Mean Number of Times That the Memory Processing Module is Accessed |
5.00 | — |
| PRIMARY Mean Duration of Time Spent Using the Memory Processing Module |
57.37 | — |
| PRIMARY Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Feasibility |
78.95 | — |
| PRIMARY Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Acceptability |
73.68 | — |
| PRIMARY Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Appropriateness for Improving Psychological Distress |
68.42 | — |
| PRIMARY Percentage of Participants Who Report Total Scores ≥68 for Their Final Rating of the Intervention's Usability |
73.68 | — |
| SECONDARY Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5) Score |
21.40 | — |
| SECONDARY Patient Health Questionnaire (PHQ-8) Score |
6.75 | — |
| SECONDARY Generalized Anxiety Disorder Scale (GAD-7) Score |
5.25 | — |
| SECONDARY Anxiety Sensitivity Index (ASI) Score |
23.65 | — |
| SECONDARY International Physical Activity Questionnaire (IPAQ) Score |
3772 | — |
| SECONDARY Number of Hours of Sleep |
6.75 | — |
| SECONDARY Self-reported Use of Sleep Medication |
0.85 | — |
| SECONDARY Rating of Sleep Quality |
0.85 | — |
Summary
The overall goal of this study is to determine whether English-speaking adults who were discharged from an intensive care unit (ICU) at least one month ago and have some level of distress related to their ICU experience will be interested in, willing to use, and satisfied with a new mobile application (app) designed to help the user process a difficult memory. Participants must have internet access and a smartphone in order to use the app. The goal of the app is to help reduce the psychological distress associated with a memory by processing that memory at one's own pace with app guidance. Participants will be asked to use the app for 6 weeks at least 3 times a week for 30 or more minutes at a time. Participants will also be asked to complete questionnaires over a 12-week period.
The investigators aim to test how possible and realistic it is for people who were hospitalized with a critical illness to voluntarily use this app to process relevant distressing memories of their hospitalization. The investigators hope that these results will inform the design of a larger trial that will be able to test if this app can reduce distress in this patient population, as the app may offer affordable and accessible help for some patients experiencing illness-related distress.
Eligibility Criteria
Inclusion Criteria
- Age 18 years old or older
- Able to speak and write in English
- Previously admitted to an ICU
- Have internet access (e.g., Wi-Fi)
- Have access to an internet-equipped smartphone device (e.g., iPhone, Android)
- Meet a minimum threshold of psychological distress related to their prior critical illness as demonstrated by scoring ≥10 points on the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5, see Measures section for a complete description).
Exclusion Criteria
- ICU discharge occurred <30 days prior to the time of study enrollment
- Score <10 points on the PCL-5 during the initial eligibility screening
- Unable to comply with the protocol (either self-selected or indicating that s/he/they cannot complete all requested tasks) for reasons that include, but are not limited to, cognitive impairment (e.g., dementia), alcohol and/or substance abuse, or severe mental illness (e.g., schizophrenia).
- Unavailable for follow-up for reasons such as terminal illness and imminent plans to leave the United States (as this study may include migrant or mobile patients due to their citizenship and work issues).
Data sourced from ClinicalTrials.gov (NCT05849454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.