NCT05849454

Messy Memories: Mobile Application Therapy Following Critical Illness

Completed NA Results posted Last updated 22 September 2025

What this trial tests

NA trial testing Messy Memories Intervention in Critical Illness in 29 participants. Completed in 4 September 2024.

Timeline

31 October 2023

Primary endpoint
15 July 2024

4 September 2024

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	29
Start date	31 October 2023
Primary completion	15 July 2024
Estimated completion	4 September 2024
Sites	1 location across United States

Drugs / interventions tested

• Messy Memories Intervention

Conditions studied

• Critical Illness — all drugs for Critical Illness →
• Psychological Distress — all drugs for Psychological Distress →
• Health Behavior — all drugs for Health Behavior →

Sponsor

Columbia University

Who can join

18 and older, any sex, with Critical Illness or Psychological Distress. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Screened Participants Who Screen Eligible for the Study Primary · Baseline (pre-intervention)

This is designed to measure the feasibility of study recruitment

Group	Value	95% CI
Messy Memories Intervention	65.22	53.62 – 75.36

Percentage of Eligible Participants Who Enroll in the Study Primary · Baseline (pre-intervention)

This is designed to measure the feasibility of study enrollment

Group	Value	95% CI
Messy Memories Intervention	64.44	51.11 – 77.78

Percentage of Enrolled Participants Who Record a Memory in the Memory Processing Module Primary · End of 6-week intervention period

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

Group	Value	95% CI
Messy Memories Intervention	65.52	48.28 – 82.76

Mean Number of Times That the Memory Processing Module is Accessed Primary · End of 6-week intervention period

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.

Group	Value	95% CI
Messy Memories Intervention	5.00	± 3.25

Mean Duration of Time Spent Using the Memory Processing Module Primary · End of 6-week intervention period

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

Group	Value	95% CI
Messy Memories Intervention	57.37	± 53.10

Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Feasibility Primary · End of 6-week intervention period

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.

Group	Value	95% CI
Messy Memories Intervention	78.95	56.67 – 91.49

Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Acceptability Primary · End of 6-week intervention period

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.

Group	Value	95% CI
Messy Memories Intervention	73.68	51.21 – 88.19

Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Appropriateness for Improving Psychological Distress Primary · End of 6-week intervention period

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.

Group	Value	95% CI
Messy Memories Intervention	68.42	46.01 – 84.64

Percentage of Participants Who Report Total Scores ≥68 for Their Final Rating of the Intervention's Usability Primary · End of 6-week intervention period

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.

Group	Value	95% CI
Messy Memories Intervention	73.68	51.21 – 88.19

Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5) Score Secondary · 12 weeks

Post-traumatic stress symptoms triggered by the prior critical illness and ICU hospitalization will be assessed using the Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5). Participants are asked to rate how bothered they have been by each of 20 items in the past month on a 5-point Likert scale (0 = not at all, 4 = extremely). Items are summed to provide a total severity score ranging from 0-80, with higher scores indicating greater PTSD symptoms. A cut-point score ≥33 is considered positive for post-traumatic stress sym

Group	Value	95% CI
Messy Memories Intervention	21.40	± 16.09

Patient Health Questionnaire (PHQ-8) Score Secondary · 12 weeks

Depression will be assessed using the Patient Health Questionnaire (PHQ-8). Participants are asked to rate how bothered they have been by each of 8 items in the past two weeks on a 4-point Likert scale (0 = not at all, 3 = nearly every day). Items are summed to provide a total severity score ranging from 0-24, with higher scores indicating greater depression. A cut-point score ≥10 is considered positive for depression.

Group	Value	95% CI
Messy Memories Intervention	6.75	± 5.24

Generalized Anxiety Disorder Scale (GAD-7) Score Secondary · 12 weeks

Anxiety will be assessed using the Generalized Anxiety Disorder Scale (GAD-7). Participants are asked to rate how bothered they have been by each of 7 items in the past two weeks on a 4-point Likert scale (0 = not at all, 3 = nearly every day). Items are summed to provide a total severity score ranging from 0-21, with higher scores indicating greater anxiety. A cut-point score ≥10 is considered positive for anxiety.

Group	Value	95% CI
Messy Memories Intervention	5.25	± 4.51

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.