Trial Outcomes & Findings for Expressing Personal Recollections in English or Spanish to Alleviate Traumatic Emotions (Exprésate) (NCT NCT05090839)

NCT ID: NCT05090839

Last Updated: 2025-08-24

Results Overview

22-item self-report instrument that corresponds to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) symptoms of PTSD over last 7 days on a scale from 0 (not at all) to 4 (extremely) The IES has a total score ranging from 0 to 88 with the higher score indicating greater PTSD symptoms. The IES was assessed before and after the intervention and the change in score (mean and SD) is reported as the outcome measure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

6 weeks

Results posted on

2025-08-24

Participant Flow

Participants were recruited by flyers presented at community locations such as outpatient clinics, women's shelters, and at research centers located on the campus of the University of Miami.

Of the 40 participants enrolled, incomplete data collection resulted in 5 participants not being randomized and 6 were loss to follow-up prior to randomization. Thus, a total of 11 enrolled participants were not randomized.

Participant milestones

Participant milestones
Measure
Augmented Trauma-writing Intervention in Spanish
Participants in this group will be required to write once weekly for 4 consecutive weeks. Participants will be instructed to write objectively about what they did the day prior and to avoid writing about their emotions or opinions in Spanish. Weekly Emotional Disclosure (WED) Spanish Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day. in Spanish.
Augmented Trauma-writing Intervention in English
Participants in this group will be asked to write about their most traumatic or upsetting experiences for a total of 4 sessions (one session a week for 4 consecutive weeks) in English. Weekly Emotional Disclosure (WED) Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
Daily-event-writing Control in English
Participants in this group will be asked to conduct event writing condition in English and will be asked to write a description about what they did "yesterday from the time \[they\] got up until the time \[they\] went to bed" for 20 min continuously. They will be told to "avoid writing about \[their\] emotions or opinions" but to try to be as "accurate and objective as possible." Weekly Emotional Disclosure (WED) Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
Daily-event-writing Control in Spanish
Participants in this group will be asked to conduct event writing in condition in Spanish and will be asked to write a description about what they did "yesterday from the time \[they\] got up until the time \[they\] went to bed" for 20 min continuously. They will be told to "avoid writing about \[their\] emotions or opinions" but to try to be as "accurate and objective as possible." Weekly Emotional Disclosure (WED) Spanish Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day in Spanish.
Overall Study
STARTED
11
7
5
6
Overall Study
COMPLETED
9
4
4
5
Overall Study
NOT COMPLETED
2
3
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Augmented Trauma-writing Intervention in Spanish
Participants in this group will be required to write once weekly for 4 consecutive weeks. Participants will be instructed to write objectively about what they did the day prior and to avoid writing about their emotions or opinions in Spanish. Weekly Emotional Disclosure (WED) Spanish Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day. in Spanish.
Augmented Trauma-writing Intervention in English
Participants in this group will be asked to write about their most traumatic or upsetting experiences for a total of 4 sessions (one session a week for 4 consecutive weeks) in English. Weekly Emotional Disclosure (WED) Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
Daily-event-writing Control in English
Participants in this group will be asked to conduct event writing condition in English and will be asked to write a description about what they did "yesterday from the time \[they\] got up until the time \[they\] went to bed" for 20 min continuously. They will be told to "avoid writing about \[their\] emotions or opinions" but to try to be as "accurate and objective as possible." Weekly Emotional Disclosure (WED) Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
Daily-event-writing Control in Spanish
Participants in this group will be asked to conduct event writing in condition in Spanish and will be asked to write a description about what they did "yesterday from the time \[they\] got up until the time \[they\] went to bed" for 20 min continuously. They will be told to "avoid writing about \[their\] emotions or opinions" but to try to be as "accurate and objective as possible." Weekly Emotional Disclosure (WED) Spanish Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day in Spanish.
Overall Study
Lost to Follow-up
2
3
1
1

Baseline Characteristics

Expressing Personal Recollections in English or Spanish to Alleviate Traumatic Emotions (Exprésate)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Augmented Trauma-writing Intervention in Spanish
n=11 Participants
Participants in this group will be required to write once weekly for 4 consecutive weeks. Participants will be instructed to write objectively about what they did the day prior and to avoid writing about their emotions or opinions in Spanish. Weekly Emotional Disclosure (WED) Spanish Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day in Spanish.
Augmented Trauma-writing Intervention in English
n=7 Participants
Participants in this group will be asked to write about their most traumatic or upsetting experiences for a total of 4 sessions (one session a week for 4 consecutive weeks) in English. Weekly Emotional Disclosure (WED) Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
Daily-event-writing Control in English
n=5 Participants
Participants in this group will be asked to conduct event writing condition in English and will be asked to write a description about what they did "yesterday from the time \[they\] got up until the time \[they\] went to bed" for 20 min continuously. They will be told to "avoid writing about \[their\] emotions or opinions" but to try to be as "accurate and objective as possible." Weekly Emotional Disclosure (WED) Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
Daily-event-writing Control in Spanish
n=6 Participants
Participants in this group will be asked to conduct event writing in condition in Spanish and will be asked to write a description about what they did "yesterday from the time \[they\] got up until the time \[they\] went to bed" for 20 min continuously. They will be told to "avoid writing about \[their\] emotions or opinions" but to try to be as "accurate and objective as possible." Weekly Emotional Disclosure (WED) Spanish Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day in Spanish.
Total
n=29 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Age, Categorical
Between 18 and 65 years
11 Participants
n=5 Participants
7 Participants
n=7 Participants
5 Participants
n=5 Participants
6 Participants
n=4 Participants
29 Participants
n=21 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Sex: Female, Male
Female
11 Participants
n=5 Participants
7 Participants
n=7 Participants
5 Participants
n=5 Participants
6 Participants
n=4 Participants
29 Participants
n=21 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
11 Participants
n=5 Participants
6 Participants
n=7 Participants
5 Participants
n=5 Participants
6 Participants
n=4 Participants
28 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
Race (NIH/OMB)
White
11 Participants
n=5 Participants
6 Participants
n=7 Participants
5 Participants
n=5 Participants
6 Participants
n=4 Participants
28 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Data not analyzed from 19 participants that either did not complete a baseline or follow-up assessment of IES or who were lost to follow-up during the intervention.

22-item self-report instrument that corresponds to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) symptoms of PTSD over last 7 days on a scale from 0 (not at all) to 4 (extremely) The IES has a total score ranging from 0 to 88 with the higher score indicating greater PTSD symptoms. The IES was assessed before and after the intervention and the change in score (mean and SD) is reported as the outcome measure.

Outcome measures

Outcome measures
Measure
Augmented Trauma-writing Intervention in Spanish
n=11 Participants
Participants in this group will be required to write once weekly for 4 consecutive weeks. Participants will be instructed to write objectively about what they did the day prior and to avoid writing about their emotions or opinions in Spanish. Weekly Emotional Disclosure (WED) Spanish Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day. in Spanish.
Augmented Trauma-writing Intervention in English
n=7 Participants
Participants in this group will be asked to write about their most traumatic or upsetting experiences for a total of 4 sessions (one session a week for 4 consecutive weeks) in English. Weekly Emotional Disclosure (WED) Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
Daily-event-writing Control in English
n=6 Participants
Participants in this group will be asked to conduct event writing condition in English and will be asked to write a description about what they did "yesterday from the time \[they\] got up until the time \[they\] went to bed" for 20 min continuously. They will be told to "avoid writing about \[their\] emotions or opinions" but to try to be as "accurate and objective as possible." Weekly Emotional Disclosure (WED) Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
Daily-event-writing Control in Spanish
n=5 Participants
Participants in this group will be asked to conduct event writing in condition in Spanish and will be asked to write a description about what they did "yesterday from the time \[they\] got up until the time \[they\] went to bed" for 20 min continuously. They will be told to "avoid writing about \[their\] emotions or opinions" but to try to be as "accurate and objective as possible." Weekly Emotional Disclosure (WED) Spanish Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
Change in PTSD Symptoms as Assessed by the Impact of Event Scale
-.383 score on a scale
Standard Deviation 12.19
6.43 score on a scale
Standard Deviation 4.27
-3.18 score on a scale
Standard Deviation 16.22
-2.11 score on a scale
Standard Deviation 9.59

PRIMARY outcome

Timeframe: baseline

Population: Data could not be collected at both timepoints due to time restraints and participant burden during. Hence, there was only one assessment of delayed recall performance on the HVLT.

Measures verbal learning and memory function based on the initial word learning list (0 no words recalled - 12 all words recalled).

Outcome measures

Outcome measures
Measure
Augmented Trauma-writing Intervention in Spanish
n=7 Participants
Participants in this group will be required to write once weekly for 4 consecutive weeks. Participants will be instructed to write objectively about what they did the day prior and to avoid writing about their emotions or opinions in Spanish. Weekly Emotional Disclosure (WED) Spanish Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day. in Spanish.
Augmented Trauma-writing Intervention in English
n=3 Participants
Participants in this group will be asked to write about their most traumatic or upsetting experiences for a total of 4 sessions (one session a week for 4 consecutive weeks) in English. Weekly Emotional Disclosure (WED) Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
Daily-event-writing Control in English
n=2 Participants
Participants in this group will be asked to conduct event writing condition in English and will be asked to write a description about what they did "yesterday from the time \[they\] got up until the time \[they\] went to bed" for 20 min continuously. They will be told to "avoid writing about \[their\] emotions or opinions" but to try to be as "accurate and objective as possible." Weekly Emotional Disclosure (WED) Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
Daily-event-writing Control in Spanish
n=5 Participants
Participants in this group will be asked to conduct event writing in condition in Spanish and will be asked to write a description about what they did "yesterday from the time \[they\] got up until the time \[they\] went to bed" for 20 min continuously. They will be told to "avoid writing about \[their\] emotions or opinions" but to try to be as "accurate and objective as possible." Weekly Emotional Disclosure (WED) Spanish Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
Changes in Verbal Learning as Assessed by Hopkins Verbal Learning Task
10.43 Total words recalled following delay.
Standard Deviation 1.272
11.67 Total words recalled following delay.
Standard Deviation .577
12 Total words recalled following delay.
Standard Deviation .00
9.80 Total words recalled following delay.
Standard Deviation 1.92

SECONDARY outcome

Timeframe: 6 weeks

Population: Data not analyzed from 23 participants that either did not complete a baseline or follow-up fMRI assessment, or who's data could not be analyzed due to fMRI data not passing quality control (e.g., excessive motion, did not finish scan, signal distortion, etc.)

DMN is a large-scale network of interacting brain regions implicated in emotion and memory. Activity of the DMN hub indexed by Beta weight of activity within the ventral medial prefrontal cortex (VMPFC) was compared as a contrast between the visualizing trauma vs. visualizing stress conditions of the exposure. The VMPFC hub of the default mode network is a region integral to emotion regulation and is shown to be active during the use of cognitive-emotional regulation tasks (Andrewes and Jenkins, 2019). Hence, a randomization related increase in VMPFC activity while processing traumatic memories is associated with greater task engagement and cognitive-emotion regulation, which is a positive outcome.

Outcome measures

Outcome measures
Measure
Augmented Trauma-writing Intervention in Spanish
n=8 Participants
Participants in this group will be required to write once weekly for 4 consecutive weeks. Participants will be instructed to write objectively about what they did the day prior and to avoid writing about their emotions or opinions in Spanish. Weekly Emotional Disclosure (WED) Spanish Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day. in Spanish.
Augmented Trauma-writing Intervention in English
n=2 Participants
Participants in this group will be asked to write about their most traumatic or upsetting experiences for a total of 4 sessions (one session a week for 4 consecutive weeks) in English. Weekly Emotional Disclosure (WED) Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
Daily-event-writing Control in English
n=3 Participants
Participants in this group will be asked to conduct event writing condition in English and will be asked to write a description about what they did "yesterday from the time \[they\] got up until the time \[they\] went to bed" for 20 min continuously. They will be told to "avoid writing about \[their\] emotions or opinions" but to try to be as "accurate and objective as possible." Weekly Emotional Disclosure (WED) Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
Daily-event-writing Control in Spanish
n=4 Participants
Participants in this group will be asked to conduct event writing in condition in Spanish and will be asked to write a description about what they did "yesterday from the time \[they\] got up until the time \[they\] went to bed" for 20 min continuously. They will be told to "avoid writing about \[their\] emotions or opinions" but to try to be as "accurate and objective as possible." Weekly Emotional Disclosure (WED) Spanish Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
Change in Functional Activity of the Default Mode Network (DMN).
.702 Beta-weight reflecting change in BOLD
Standard Deviation .858
-.716 Beta-weight reflecting change in BOLD
Standard Deviation .906
-.225 Beta-weight reflecting change in BOLD
Standard Deviation .543
-.118 Beta-weight reflecting change in BOLD
Standard Deviation .762

SECONDARY outcome

Timeframe: 6 weeks

Population: Data not analyzed from 29 participants that either did not complete a baseline or follow-up saliva collection or associated trauma recall tasks, were lost to follow-up during the intervention, had missing data from 1 of the three salivary time collection points, or samples not correctly recorded or collected.

200 uL of saliva will be used for immunosorbent assay of salivary alpha amylase (sAA) measured by picograms per milliliter

Outcome measures

Outcome measures
Measure
Augmented Trauma-writing Intervention in Spanish
n=1 Participants
Participants in this group will be required to write once weekly for 4 consecutive weeks. Participants will be instructed to write objectively about what they did the day prior and to avoid writing about their emotions or opinions in Spanish. Weekly Emotional Disclosure (WED) Spanish Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day. in Spanish.
Augmented Trauma-writing Intervention in English
n=3 Participants
Participants in this group will be asked to write about their most traumatic or upsetting experiences for a total of 4 sessions (one session a week for 4 consecutive weeks) in English. Weekly Emotional Disclosure (WED) Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
Daily-event-writing Control in English
n=3 Participants
Participants in this group will be asked to conduct event writing condition in English and will be asked to write a description about what they did "yesterday from the time \[they\] got up until the time \[they\] went to bed" for 20 min continuously. They will be told to "avoid writing about \[their\] emotions or opinions" but to try to be as "accurate and objective as possible." Weekly Emotional Disclosure (WED) Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
Daily-event-writing Control in Spanish
n=4 Participants
Participants in this group will be asked to conduct event writing in condition in Spanish and will be asked to write a description about what they did "yesterday from the time \[they\] got up until the time \[they\] went to bed" for 20 min continuously. They will be told to "avoid writing about \[their\] emotions or opinions" but to try to be as "accurate and objective as possible." Weekly Emotional Disclosure (WED) Spanish Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
Change in Salivary Measures of Stress Reactivity.
-871.9 picograms per milliliter
Standard Deviation NA
Only 1 participant in this cell.
-250.87 picograms per milliliter
Standard Deviation 11.9
-622.3 picograms per milliliter
Standard Deviation 487.1
-129.53 picograms per milliliter
Standard Deviation 267.15

Adverse Events

Augmented Trauma-writing Intervention in Spanish

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Augmented Trauma-writing Intervention in English

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Daily-event-writing Control in English

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Daily-event-writing Control in Spanish

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Roger McIntosh

University of Miami

Phone: 3052435166

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place