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

NCT05090839 | Completed Results

• 2 other identifiers: 201907605U54MD002266-15
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Functional Activity of the Default Mode Network (DMN).

  6 weeks

• Change in Salivary Measures of Stress Reactivity.

  6 weeks

Study Arms (4)

Augmented trauma-writing intervention in Spanish

EXPERIMENTAL

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

Augmented trauma-writing intervention in English

EXPERIMENTAL

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)

Daily-event-writing control in English

ACTIVE COMPARATOR

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)

Daily-event-writing control in Spanish

ACTIVE COMPARATOR

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

Interventions

Weekly Emotional Disclosure (WED) BEHAVIORAL

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.

Augmented trauma-writing intervention in English; Daily-event-writing control in English

Weekly Emotional Disclosure (WED) Spanish BEHAVIORAL

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 Spanish; Daily-event-writing control in Spanish

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 21 years
• 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
• On a stable anti-retroviral therapy regimen for \> 6 months as assessed with the Adult AIDS Clinical Trial Group structured interview
• Spanish-English bilingual as measured by the Brief Acculturation Scale for Hispanics (cut-off of 3), Spanish speaker or English speaker
• Participant is willing and able to sign Informed Consent Form (ICF)
• self-report as Latina
• HIV positive serostatus as determined by medical record within the last 12 months
• Born female.

You may not qualify if:

• Left-handedness or ambidextrous
• Inability to tolerate the scanning procedures
• Metal in body or prior history working with metal fragments
• Any other contraindications for MRI examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body)
• currently pregnant or could be pregnant
• Heavy alcohol intake (\> 3 drinks) within 12 hours prior to participation in Functional Magnetic Resonance Imaging (fMRI)
• Evidence from health history of neurological or systemic disorder which can cause cognitive impairment
• Self-reported current diagnosis of psychiatric disorder or psychoactive substance abuse or dependence
• Recent history (within two years) of myocardial infarction
• Severe cardiovascular disease, or currently active cardiovascular disease (e.g., angina, cardiomyopathy)
• Uncontrolled hypertension or hypotension
• History of closed trauma with loss of consciousness
• Space occupying lesions (e.g., mass lesions, tumors)
• Central Nervous System (CNS) infection
• CNS vasculitis

Sponsors & Collaborators

• University of Miami: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33143, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Roger McIntosh
• Organization: University of Miami

r.mcintosh@miami.edu

3052435166

Study Officials

• Roger McIntosh

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start: August 18, 2021
• Primary Completion: February 1, 2023
• Study Completion: December 2, 2023
• Last Updated: August 24, 2025
• Results First Posted: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)