Critical IllnessNCT05849454
Messy Memories: Mobile Application Therapy Following Critical Illness
A study testing Messy Memories Intervention in people with Critical Illness and Psychological Distress, run by Columbia University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Psychological Distress, Health Behavior
- What is being tested?
- Messy Memories Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2023to 4 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Messy Memories: A Mobile Application Exposure Therapy Intervention to Reduce Psychological Distress and Improve Health Behaviors Following Critical Illness
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.
Read the detailed description
Critical illness can be an incredibly traumatic experience, often involving treatment in the intensive care unit (ICU), intubation or other invasive medical procedures, altered levels of consciousness, inability to communicate, sensory and sleep deprivation, physical pain, and delirium. The cumulative physical and psychological stress associated with critical illness can be severe enough to induce clinically-significant symptoms of posttraumatic stress disorder (PTSD). Patients with PTSD symptoms related to prior traumatic medical events are more likely to engage in unhealthy behaviors, such as tobacco use, sedentary lifestyle, poor diet, and medication nonadherence.
Exposure therapy (ET) is considered the gold standard treatment for PTSD and involves repeated exposure to trauma-related stimuli leading to habituation of maladaptive emotional responses and an increased sense of control and self-competence. ET is highly effective for improving PTSD triggered by more typical forms of trauma, such as military combat or sexual assault, but less is known about the role of ET for reducing PTSD symptoms after critical illness.
The goal of this pilot study is to conduct preliminary testing of a newly developed mobile application (Messy Memories) that uses remotely delivered ET to reduce psychological distress and improve health behaviors in survivors of critical illness. The user is asked to audio record a traumatic or distressing memory and process what it feels like to re-experience the memory. Users can return to their recorded memory as often as they like until it becomes easier to re-experience.
The investigators will assess the feasibility and acceptability of recruiting and engaging critical illness survivors in the Messy Memories intervention. They will also explore the efficacy of the intervention for engaging the mechanistic target (PTSD symptoms) to reduce psychological distress. Additional outcomes will include reduction in other psychological symptoms (e.g., depression, anxiety) and improvement in health behaviors (e.g., sleep patterns, physical activity). The results of this study will form the basis of a future adequately powered randomized controlled trial testing whether the Messy Memories intervention can significantly reduce psychological distress and, in turn, improve behavioral outcomes among critical illness survivors.
Aim 1: Assess the feasibility of recruiting and engaging critical illness survivors in a mobile application-based exposure therapy intervention (Messy Memories). Hypothesis: The intervention will be feasible based on recruitment, retention, and completion rates of ≥70%.
Aim 2: Assess the acceptability of recruiting and engaging critical illness survivors in a mobile application-based exposure therapy intervention (Messy Memories). Hypothesis: The intervention will be acceptable based on participant satisfaction ratings of ≥70% and qualitative analysis of exit survey responses.
Aim 3 (exploratory): Assess engagement of the mechanistic target (PTSD symptoms) by the mobile application-based exposure therapy intervention (Messy Memories). Hypothesis: Participants will report improvement in PTSD symptoms, based on pre-/post-intervention decrease in scores on the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5).
Participants will be asked to engage with the Messy Memories application at least 3 days a week for at least 30 minutes each day using their own mobile smartphone device. Participants may proceed through the modules of the application at their own pace and may return to any module as many times as they desire throughout the 6-week intervention period. Mechanistic target and clinical symptom assessments will occur at Week 0 (baseline), Week 3 (mid-intervention), Week 6 (end of intervention), and Week 12 (follow-up). All study procedures, including eligibility screening, consent process, outcome assessments, and exit surveys, will be conducted remotely via telephone or Zoom video conference.
- Conditions
- Critical Illness, Psychological Distress, Health Behavior
- Being tested
- Messy Memories Intervention
- 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
- Medical subject headings
- Critical Illness, Health Behavior, Stress Disorders, Post-Traumatic, Mental Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Messy Memories InterventionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Messy Memories Intervention | Experimental | All participants enrolled in the study will be assigned to the experimental arm and participate in the Messy Memories intervention. Receives: Device: Messy Memories Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Screened Participants Who Screen Eligible for the Study
This is designed to measure the feasibility of study recruitment
Measured: Baseline (pre-intervention)
Percentage of Eligible Participants Who Enroll in the Study
This is designed to measure the feasibility of study enrollment
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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 symptoms in civilian/primary care populations.
Measured: 12 weeks
Patient Health Questionnaire (PHQ-8) Score
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.
Measured: 12 weeks
Generalized Anxiety Disorder Scale (GAD-7) Score
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.
Measured: 12 weeks
Anxiety Sensitivity Index (ASI) Score
Anxiety sensitivity will be assessed using the Anxiety Sensitivity Index (ASI). Participants are asked to rate each of 16 items specifying different concerns someone could have regarding their anxiety on a 5-point Likert scale (0 = very little, 4 = very much). Items are summed to provide a total severity score ranging from 0-48, with higher scores indicating greater anxiety sensitivity. A cut-point score ≥17 is considered positive for anxiety sensitivity.
Measured: 12 weeks
International Physical Activity Questionnaire (IPAQ) Score
The 7-item subscale of the International Physical Activity Questionnaire (IPAQ) will be used to measure physical activity. Participants are asked to self-report the intensity, frequency, and duration of physical activity performed over the last 7 days. Responses are converted to metabolic equivalent of task (MET) minutes/week. Scores range from 0 MET minutes/week to 19,782 MET minutes/week, with higher scores indicating greater physical activity. There are no official cut-points for this subscale, but it may be dichotomized as "sufficient physical activity" (≥500 MET minutes/week) vs "insufficient physical activity" (<500 MET minutes/week).
Measured: 12 weeks
Number of Hours of Sleep
Participants will be asked "During the past month, how many hours of actual sleep did you get at night (this may be different than the number of hours you spent in bed)?" Responses are given in number of hours and range from 0 to >10, with higher values indicating greater hours of sleep. There are no official cut-points for this item, but it may be dichotomized as "short sleep duration" (< 7 hours of sleep) vs "not short sleep duration" (≥7 hours of sleep).
Measured: 12 weeks
Self-reported Use of Sleep Medication
Participants will be asked "During the past month, how often have you taken medicine to help you sleep (prescribed or 'over the counter')?" Responses are given on a 4-point Likert scale (0 = not during the past month, 1 = less than once a week, 2 = once or twice a week, 3 = three of more times a week), with higher values indicating greater medication use. There are no official cut-points for this item, but it may be dichotomized as "no habitual use of sleep medication" (score of 0 or 1) vs "at least some use of sleep medication" (score of 2 or 3).
Measured: 12 weeks
Rating of Sleep Quality
Participants will be asked "During the past month, how would you rate your sleep quality overall?" Responses are given on a 4-point Likert scale (0 = very good, 1 = fairly good, 2 = fairly bad, 3 = very bad), with higher values indicating worse sleep quality. There are no official cut-points for this item, but it may be dichotomized as "good quality sleep" (score of 0 or 1) vs "bad quality sleep" (score of 2 or 3).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start31 Oct 2023
- Primary completion15 Jul 2024
- Study completion4 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Nadia A. Liyanage-Don, Columbia University
- Investigators
- Nadia Liyanage-Don, MD, MS, Principal investigator, Columbia UniversityIan Kronish, MD, MPH, Study director, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849454
- Sponsor's protocol ID
- AAAU1653
- Other IDs
- 5P30AG064198-04
- Status last verified
- Sep 2025
- First submitted
- 28 Apr 2023
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Messy Memories: A Mobile Application Exposure Therapy Intervention to Reduce Psychological Distress and Improve Health Behaviors Following Critical Illness
- ClinicalTrials.gov ID
- NCT05849454
- Acronym / sponsor ID
- AAAU1653
- Conditions
- Critical Illness, Psychological Distress, Health Behavior
- Keywords
- Critical Illness, Psychological Distress, Health Behavior, Post Traumatic Stress Disorder, Exposure Therapy, Intervention, Mental Disorders, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 4 Sep 2024 (actual)
- First posted
- 8 May 2023 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Critical illness can be an incredibly traumatic experience, often involving treatment in the intensive care unit (ICU), intubation or other invasive medical procedures, altered levels of consciousness, inability to communicate, sensory and sleep deprivation, physical pain, and delirium. The cumulative physical and psychological stress associated with critical illness can be severe enough to induce clinically-significant symptoms of posttraumatic stress disorder (PTSD). Patients with PTSD symptoms related to prior traumatic medical events are more likely to engage in unhealthy behaviors, such as tobacco use, sedentary lifestyle, poor diet, and medication nonadherence.
Exposure therapy (ET) is considered the gold standard treatment for PTSD and involves repeated exposure to trauma-related stimuli leading to habituation of maladaptive emotional responses and an increased sense of control and self-competence. ET is highly effective for improving PTSD triggered by more typical forms of trauma, such as military combat or sexual assault, but less is known about the role of ET for reducing PTSD symptoms after critical illness.
The goal of this pilot study is to conduct preliminary testing of a newly developed mobile application (Messy Memories) that uses remotely delivered ET to reduce psychological distress and improve health behaviors in survivors of critical illness. The user is asked to audio record a traumatic or distressing memory and process what it feels like to re-experience the memory. Users can return to their recorded memory as often as they like until it becomes easier to re-experience.
The investigators will assess the feasibility and acceptability of recruiting and engaging critical illness survivors in the Messy Memories intervention. They will also explore the efficacy of the intervention for engaging the mechanistic target (PTSD symptoms) to reduce psychological distress. Additional outcomes will include reduction in other psychological symptoms (e.g., depression, anxiety) and improvement in health behaviors (e.g., sleep patterns, physical activity). The results of this study will form the basis of a future adequately powered randomized controlled trial testing whether the Messy Memories intervention can significantly reduce psychological distress and, in turn, improve behavioral outcomes among critical illness survivors.
Aim 1: Assess the feasibility of recruiting and engaging critical illness survivors in a mobile application-based exposure therapy intervention (Messy Memories). Hypothesis: The intervention will be feasible based on recruitment, retention, and completion rates of ≥70%.
Aim 2: Assess the acceptability of recruiting and engaging critical illness survivors in a mobile application-based exposure therapy intervention (Messy Memories). Hypothesis: The intervention will be acceptable based on participant satisfaction ratings of ≥70% and qualitative analysis of exit survey responses.
Aim 3 (exploratory): Assess engagement of the mechanistic target (PTSD symptoms) by the mobile application-based exposure therapy intervention (Messy Memories). Hypothesis: Participants will report improvement in PTSD symptoms, based on pre-/post-intervention decrease in scores on the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5).
Participants will be asked to engage with the Messy Memories application at least 3 days a week for at least 30 minutes each day using their own mobile smartphone device. Participants may proceed through the modules of the application at their own pace and may return to any module as many times as they desire throughout the 6-week intervention period. Mechanistic target and clinical symptom assessments will occur at Week 0 (baseline), Week 3 (mid-intervention), Week 6 (end of intervention), and Week 12 (follow-up). All study procedures, including eligibility screening, consent process, outcome assessments, and exit surveys, will be conducted remotely via telephone or Zoom video conference.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Messy Memories Intervention | Experimental | Device: Messy Memories InterventionAll participants enrolled in the study will be assigned to the experimental arm and participate in the Messy Memories intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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).
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 InterventionMessy 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. | Device | Messy Memories Intervention |
Primary outcome
Percentage of Screened Participants Who Screen Eligible for the Study
Time frame: Baseline (pre-intervention)
This is designed to measure the feasibility of study recruitment
Percentage of Eligible Participants Who Enroll in the Study
Time frame: Baseline (pre-intervention)
This is designed to measure the feasibility of study enrollment
Percentage of Enrolled Participants Who Record a Memory in the Memory Processing Module
Time frame: End of 6-week intervention period
This is designed to measure the feasibility of engaging with the intervention
Mean Number of Times That the Memory Processing Module is Accessed
Time frame: 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.
Mean Duration of Time Spent Using the Memory Processing Module
Time frame: End of 6-week intervention period
This is designed to measure the feasibility of engaging with the intervention
Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Feasibility
Time frame: 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.
Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Acceptability
Time frame: 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.
Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Appropriateness for Improving Psychological Distress
Time frame: 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.
Percentage of Participants Who Report Total Scores ≥68 for Their Final Rating of the Intervention's Usability
Time frame: 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.
8 secondary outcomes
Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5) Score
Time frame: 12 weeks
Patient Health Questionnaire (PHQ-8) Score
Time frame: 12 weeks
Generalized Anxiety Disorder Scale (GAD-7) Score
Time frame: 12 weeks
Anxiety Sensitivity Index (ASI) Score
Time frame: 12 weeks
International Physical Activity Questionnaire (IPAQ) Score
Time frame: 12 weeks
Number of Hours of Sleep
Time frame: 12 weeks
Self-reported Use of Sleep Medication
Time frame: 12 weeks
Rating of Sleep Quality
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Nadia Liyanage-Don, MD, MS principal investigator
Columbia University
Ian Kronish, MD, MPH study director
Columbia 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 Intervention in people with Critical Illness and Psychological Distress, run by Columbia 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 6 inclusion and 4 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 22 Sep 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?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Screened Participants Who Screen Eligible for the Study (time frame: Baseline (pre-intervention)). The study lists 9 primary outcomes in all. 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 22 Sep 2025.