Messy Memories: Mobile Application Therapy Following Critical Illness

Critical Illness Clinical Trial

Official title:

Messy Memories: A Mobile Application Exposure Therapy Intervention to Reduce Psychological Distress and Improve Health Behaviors Following Critical Illness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05849454
• Other study ID #: AAAU1653
• Secondary ID: 5P30AG064198-04
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: March 2024
• Source: Columbia University
• Contact: Nadia Liyanage-Don, MD, MS
• Phone: 212-305-6354
• Email: nal2151[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Critical Illness
• Health Behavior
• Psychological Distress

Intervention

Device:
• Messy Memories Intervention
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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of screened participants who screen eligible for the study	This is designed to measure the feasibility of study recruitment.	Baseline (pre-intervention)
Primary	Proportion of eligible participants who enroll in the study	This is designed to measure the feasibility of study enrollment.	Baseline (pre-intervention)
Primary	Proportion 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
Primary	Mean number of times that the Memory Processing module is accessed	This is designed to measure the feasibility of engaging with the intervention.	End of 6-week intervention period
Primary	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
Primary	Proportion 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
Primary	Proportion 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
Primary	Proportion 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
Primary	Proportion 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	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 =34 is considered positive for post-traumatic stress symptoms.	Up to 12 weeks
Secondary	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.	Up to 12 weeks
Secondary	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.	Up to 12 weeks
Secondary	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.	Up to 12 weeks
Secondary	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).	Up to 12 weeks
Secondary	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).	Up to 12 weeks
Secondary	Frequency of sleep medication use	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).	Up to 12 weeks
Secondary	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).	Up to 12 weeks