Trial Outcomes & Findings for Messy Memories: Mobile Application Therapy Following Critical Illness (NCT NCT05849454)

Results Overview

This is designed to measure the feasibility of study recruitment

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

Baseline (pre-intervention)

Results posted on

2025-09-22

Participant Flow

ICU survivors were recruited nationwide between October 1, 2023 and May 31, 2024. The study was advertised to intensivists, post-ICU support groups, and ICU recovery clinics, as well as through online registries (e.g., RecruitMe, ResearchMatch, ClinicalTrials.gov), patient advocacy organizations (e.g., Sudden Cardiac Arrest Foundation), and relevant Facebook groups (e.g., ICU Survivor Support Group). IRB-approved flyers, emails, and presentations were used to promote the study.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	69
Overall Study Screened Eligible for Study	45
Overall Study Signed Consent Form	29
Overall Study Completed Baseline Visit	25
Overall Study Completed 3-Week Visit	22
Overall Study Completed 6-Week Visit	19
Overall Study Completed 12-Week Visit	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	50

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Messy Memories: Mobile Application Therapy Following Critical Illness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Messy Memories Intervention n=29 Participants 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.
Age, Continuous	39 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	29 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Education Trade/Vocational School	1 Participants n=5 Participants
Education Some College	9 Participants n=5 Participants
Education Associate's Degree	2 Participants n=5 Participants
Education College Graduate	10 Participants n=5 Participants
Education Graduate/Professional School	7 Participants n=5 Participants
Annual Household Income <$10,000	2 Participants n=5 Participants
Annual Household Income $10,000 - $24,999	2 Participants n=5 Participants
Annual Household Income $25,000 - $49,999	4 Participants n=5 Participants
Annual Household Income $50,000 - $74,999	5 Participants n=5 Participants
Annual Household Income $75,000 - $99,999	10 Participants n=5 Participants
Annual Household Income ≥$100,000	5 Participants n=5 Participants
Annual Household Income Declined	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (pre-intervention)

Population: Because this was a feasibility study, we were interested in examining how many individuals needed to be screened to reach the target sample. Therefore, one of our primary outcome measures was the proportion of screened participants who screened eligible for the study. This would necessarily make the overall number of participants analyzed for this measure greater than the number of participants assigned to the arms or groups in the Participant Flow.

This is designed to measure the feasibility of study recruitment

Outcome measures

Outcome measures
Measure	Messy Memories Intervention n=69 Participants 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.
Percentage of Screened Participants Who Screen Eligible for the Study	65.22 percentage of participants Interval 53.62 to 75.36

PRIMARY outcome

Timeframe: Baseline (pre-intervention)

Population: Because this was a feasibility study, we were interested in examining how many individuals who screened eligible for the study would ultimately consent to study enrollment. Therefore, one of our primary outcome measures was the proportion of eligible participants who enrolled in the study. This would necessarily make the overall number of participants analyzed for this measure greater than the number of participants assigned to the arms or groups in the Participant Flow.

This is designed to measure the feasibility of study enrollment

Outcome measures

Outcome measures
Measure	Messy Memories Intervention n=45 Participants 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.
Percentage of Eligible Participants Who Enroll in the Study	64.44 percentage of participants Interval 51.11 to 77.78

PRIMARY outcome

Timeframe: End of 6-week intervention period

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

Outcome measures

Outcome measures
Measure	Messy Memories Intervention n=29 Participants 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.
Percentage of Enrolled Participants Who Record a Memory in the Memory Processing Module	65.52 percentage of participants Interval 48.28 to 82.76

PRIMARY outcome

Timeframe: End of 6-week intervention period

Population: Not all participants who enrolled in the study engaged with the Messy Memories app, hence the difference between the number of participants analyzed here and the number of participants assigned to the arms or groups in the Participant Flow.

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.

Outcome measures

Outcome measures
Measure	Messy Memories Intervention n=19 Participants 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.
Mean Number of Times That the Memory Processing Module is Accessed	5.00 access per participant Standard Deviation 3.25

PRIMARY outcome

Timeframe: End of 6-week intervention period

Population: Not all participants who enrolled in the study engaged with the Messy Memories app, hence the difference between the number of participants analyzed here and the number of participants assigned to the arms or groups in the Participant Flow.

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

Outcome measures

Outcome measures
Measure	Messy Memories Intervention n=19 Participants 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.
Mean Duration of Time Spent Using the Memory Processing Module	57.37 minutes Standard Deviation 53.10

PRIMARY outcome

Timeframe: End of 6-week intervention period

Population: Not all participants who enrolled in the study completed the 6-week (post-intervention) visit during which the FIM was administered, hence the difference between the number of participants analyzed here and the number of participants assigned to the arms or groups in the Participant Flow.

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.

Outcome measures

Outcome measures
Measure	Messy Memories Intervention n=19 Participants 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.
Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Feasibility	78.95 percentage of participants Interval 56.67 to 91.49

PRIMARY outcome

Timeframe: End of 6-week intervention period

Population: Not all participants who enrolled in the study completed the 6-week (post-intervention) visit during which the AIM was administered, hence the difference between the number of participants analyzed here and the number of participants assigned to the arms or groups in the Participant Flow.

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.

Outcome measures

Outcome measures
Measure	Messy Memories Intervention n=19 Participants 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.
Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Acceptability	73.68 percentage of participants Interval 51.21 to 88.19

PRIMARY outcome

Timeframe: End of 6-week intervention period

Population: Not all participants who enrolled in the study completed the 6-week (post-intervention) visit during which the IAM was administered, hence the difference between the number of participants analyzed here and the number of participants assigned to the arms or groups in the Participant Flow.

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.

Outcome measures

Outcome measures
Measure	Messy Memories Intervention n=19 Participants 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.
Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Appropriateness for Improving Psychological Distress	68.42 percentage of participants Interval 46.01 to 84.64

PRIMARY outcome

Timeframe: End of 6-week intervention period

Population: Not all participants who enrolled in the study completed the 6-week (post-intervention) visit during which the SUS was administered, hence the difference between the number of participants analyzed here and the number of participants assigned to the arms or groups in the Participant Flow.

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.