Clinical trial NCT05849454: Messy Memories: Mobile Application Therapy Following Critical Illness
Official title: Messy Memories: A Mobile Application Exposure Therapy Intervention to Reduce Psychological Distress and Improve Health Behaviors Following Critical Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-05-08
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

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).

Primary outcomes:
measure: Proportion of screened participants who screen eligible for the study
timeFrame: Baseline (pre-intervention)
measure: Proportion of eligible participants who enroll in the study
timeFrame: Baseline (pre-intervention)
measure: Proportion of enrolled participants who record a memory in the Memory Processing module
timeFrame: End of 6-week intervention period
measure: Mean number of times that the Memory Processing module is accessed
timeFrame: End of 6-week intervention period
measure: Mean duration of time spent using the Memory Processing module
timeFrame: End of 6-week intervention period
measure: Proportion of participants who report scores ≥4 for their final rating of the intervention's feasibility
timeFrame: End of 6-week intervention period
measure: Proportion of participants who report scores ≥4 for their final rating of the intervention's acceptability
timeFrame: End of 6-week intervention period
measure: Proportion of participants who report scores ≥4 for their final rating of the intervention's appropriateness for improving psychological distress
timeFrame: End of 6-week intervention period
measure: Proportion of participants who report total scores ≥68 for their final rating of the intervention's usability
timeFrame: End of 6-week intervention period
Secondary outcomes:
measure: Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (PCL-5) score
timeFrame: Up to 12 weeks
measure: Patient Health Questionnaire (PHQ-8) score
timeFrame: Up to 12 weeks
measure: Generalized Anxiety Disorder Scale (GAD-7) score
timeFrame: Up to 12 weeks
measure: Anxiety Sensitivity Index (ASI) score
timeFrame: Up to 12 weeks
measure: International Physical Activity Questionnaire (IPAQ) score
timeFrame: Up to 12 weeks
measure: Number of hours of sleep
timeFrame: Up to 12 weeks
measure: Frequency of sleep medication use
timeFrame: Up to 12 weeks
measure: Rating of sleep quality
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Nadia Liyanage-Don, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Ian Kronish, MD, MPH
role: STUDY_DIRECTOR
References: