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

The purpose of this study is to test if expressive writing about traumatic events has positive changes in women living with post-traumatic stress.

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Weekly Emotional Disclosure (WED) Spanish; Behavioral: Weekly Emotional Disclosure (WED)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 21 years
2. Elevated PTSD symptoms as assessed by the Post-Traumatic Stress Disorder Checklist Scale-Version DSM 5 (PCL-5) using a cut-off of 34 or above
3. On a stable anti-retroviral therapy regimen for > 6 months as assessed with the Adult AIDS Clinical Trial Group structured interview
4. Spanish-English bilingual as measured by the Brief Acculturation Scale for Hispanics (cut-off of 3), Spanish speaker or English speaker
5. Participant is willing and able to sign Informed Consent Form (ICF)
6. self-report as Latina
7. HIV positive serostatus as determined by medical record within the last 12 months
8. Born female.

Exclusion Criteria:

1. Left-handedness or ambidextrous
2. Inability to tolerate the scanning procedures
3. Metal in body or prior history working with metal fragments
4. Any other contraindications for MRI examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body)
5. currently pregnant or could be pregnant
6. Heavy alcohol intake (> 3 drinks) within 12 hours prior to participation in Functional Magnetic Resonance Imaging (fMRI)
7. Evidence from health history of neurological or systemic disorder which can cause cognitive impairment
8. Self-reported current diagnosis of psychiatric disorder or psychoactive substance abuse or dependence
9. Recent history (within two years) of myocardial infarction
10. Severe cardiovascular disease, or currently active cardiovascular disease (e.g., angina, cardiomyopathy)
11. Uncontrolled hypertension or hypotension
12. History of closed trauma with loss of consciousness
13. Space occupying lesions (e.g., mass lesions, tumors)
14. Central Nervous System (CNS) infection
15. CNS vasculitis
16. CNS demyelinating disease (e.g., multiple sclerosis)
17. Congenital CNS abnormality (e.g., cerebral palsy)
18. Seizure disorders
19. History of cerebrovascular disease (e.g., stroke, TIA's)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.
Active Comparator: 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."	Behavioral: 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.
Active Comparator: 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."	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PTSD Symptoms as Assessed by the Impact of Event Scale	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.	6 weeks
Changes in Verbal Learning as Assessed by Hopkins Verbal Learning Task	Measures verbal learning and memory function based on the initial word learning list (0 no words recalled - 12 all words recalled).	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Activity of the Default Mode Network (DMN).	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.	6 weeks
Change in Salivary Measures of Stress Reactivity.	200 uL of saliva will be used for immunosorbent assay of salivary alpha amylase (sAA) measured by picograms per milliliter	6 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Roger McIntosh, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): December 2, 2023

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 20190760; 5U54MD002266-15 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No