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OpenTrials
Completed

NCT Number: NCT05090839

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

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • CNS demyelinating disease (e.g., multiple sclerosis)
  • Congenital CNS abnormality (e.g., cerebral palsy)
  • Seizure disorders
  • History of cerebrovascular disease (e.g., stroke, TIA's)

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in PTSD Symptoms as Assessed by the Impact of Event Scale

    Time frame: 6 weeks

    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.

  2. Changes in Verbal Learning as Assessed by Hopkins Verbal Learning Task

    Time frame: baseline

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

Secondary outcomes

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

    Time frame: 6 weeks

    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.

  2. Change in Salivary Measures of Stress Reactivity.

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Acronym: Exprésate

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2021
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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