Messy Memories: Mobile Application Therapy Following Critical Illness

NCT05849454 | Completed Results FDA Device

• 2 other identifiers: AAAU16535P30AG064198-04
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness; Psychological Distress; Health Behavior

Keywords

Critical Illness; Psychological Distress; Health Behavior; Post Traumatic Stress Disorder; Exposure Therapy; Intervention; Mental Disorders; Feasibility; Acceptability; Mobile Application; Intensive Care Unit; Trauma; Adherence

Outcome Measures

Primary Outcomes (9)

• Percentage of Screened Participants Who Screen Eligible for the Study

  This is designed to measure the feasibility of study recruitment

  Baseline (pre-intervention)

• Percentage of Eligible Participants Who Enroll in the Study

  This is designed to measure the feasibility of study enrollment

  Baseline (pre-intervention)

• Percentage of Enrolled Participants Who Record a Memory in the Memory Processing Module

  This is designed to measure the feasibility of engaging with the intervention

  End of 6-week intervention period

• Mean Number of Times That the Memory Processing Module is Accessed

  This is designed to measure the feasibility of engaging with the intervention. Of note, this outcome measure reflects the mean number of times per participant that the Memory Processing module was used to record a new memory or replay a previously recorded memory.

  End of 6-week intervention period

• Mean Duration of Time Spent Using the Memory Processing Module

  This is designed to measure the feasibility of engaging with the intervention

  End of 6-week intervention period

• Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Feasibility

  Intervention feasibility will be measured with the Feasibility of Intervention Measure (FIM). The FIM is a 4-item questionnaire answered on a 5-point Likert scale (1 = completely disagree, 5 = completely agree). Responses to each item are averaged to obtain an overall score ranging from 1-5, with higher scores indicating a better outcome. Feasibility is defined as a score ≥4.

  End of 6-week intervention period

• Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Acceptability

  Intervention acceptability will be measured with the Acceptability of Intervention Measure (AIM). The AIM is a 4-item questionnaire answered on a 5-point Likert scale (1 = completely disagree, 5 = completely agree). Responses to each item are averaged to obtain an overall score ranging from 1-5, with higher scores indicating a better outcome. Acceptability is defined as a score ≥4.

  End of 6-week intervention period

• Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Appropriateness for Improving Psychological Distress

  Intervention appropriateness will be measured with the Intervention Appropriateness Measure (IAM). The IAM is a 4-item questionnaire answered on a 5-point Likert scale (1 = completely disagree, 5 = completely agree). Responses to each item are averaged to obtain an overall score ranging from 1-5, with higher scores indicating a better outcome. Appropriateness is defined as a score ≥4.

  End of 6-week intervention period

• Percentage of Participants Who Report Total Scores ≥68 for Their Final Rating of the Intervention's Usability

  Intervention usability will be measured with the System Usability Scale (SUS). The SUS is a 10-item questionnaire answered on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Scores range from 0-100, with higher scores indicating a better outcome. Usability is defined as a score ≥68.

  End of 6-week intervention period

Secondary Outcomes (8)

• Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5) Score

  12 weeks

• Patient Health Questionnaire (PHQ-8) Score

  12 weeks

• Generalized Anxiety Disorder Scale (GAD-7) Score

  12 weeks

• Anxiety Sensitivity Index (ASI) Score

  12 weeks

• International Physical Activity Questionnaire (IPAQ) Score

  12 weeks

Study Arms (1)

Messy Memories Intervention

EXPERIMENTAL

All participants enrolled in the study will be assigned to the experimental arm and participate in the Messy Memories intervention.

Device: Messy Memories Intervention

Interventions

Messy Memories Intervention DEVICE

Messy Memories is a mobile application that allows users to self-administer exposure therapy techniques outside of the traditional psychotherapy context. Participants are asked to audio record a difficult ("messy") memory, including what they did, felt, thought, smelled, saw, etc. They are then asked questions about what it was like to re-experience the memory, such as what emotions were elicited (e.g., sadness, anger, fear). Next, participants are asked to process what the memory means to them. They are then instructed to listen to their recording as often as they like, until the memory becomes easier to re-experience. They respond to processing questions each time they listen to their prior difficult memory.

Messy Memories Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Critical Illness; Health Behavior; Stress Disorders, Post-Traumatic; Mental Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Limitations and Caveats

Limitations include inability to confirm self-reported ICU history and potential for imposter participants due to remote nature of the study. Participants received technical/onboarding support that is not typical of many apps, which may have influenced engagement. The app's availability in English only and the need for an internet-accessible smartphone limits generalizability. Finally, the small sample and lack of control group constrain our ability to draw strong conclusions about efficacy.

Results Point of Contact

• Title: Nadia Liyanage-Don
• Organization: Center for Behavioral Cardiovascular Health

nal2151@cumc.columbia.edu

917-280-3776

Study Officials

• Nadia Liyanage-Don, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

• Ian Kronish, MD, MPH

  Columbia University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 8, 2023
• Study Start: October 31, 2023
• Primary Completion: July 15, 2024
• Study Completion: September 4, 2024
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)