Post Traumatic Stress DisorderExprésateNCT05090839
Expressing Personal Recollections in English or Spanish to Alleviate Traumatic Emotions (Exprésate)
A study testing Weekly Emotional Disclosure (WED) and Weekly Emotional Disclosure (WED) Spanish in people with Post Traumatic Stress Disorder, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Weekly Emotional Disclosure (WED) and Weekly Emotional Disclosure (WED) Spanish
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2021to 2 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Weekly Emotional Disclosure (WED), Weekly Emotional Disclosure (WED) Spanish
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly Emotional Disclosure (WED)Behavioural
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) SpanishBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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." Receives: 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." Receives: Behavioral: Weekly Emotional Disclosure (WED) Spanish |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: baseline
Secondary outcomes (2)
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.
Measured: 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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start18 Aug 2021
- Primary completion1 Feb 2023
- Study completion2 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Roger McIntosh, University of Miami
- Investigators
- Roger McIntosh, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090839
- Sponsor's protocol ID
- 20190760
- Other IDs
- 5U54MD002266-15
- Acronym
- Exprésate
- Status last verified
- Aug 2025
- First submitted
- 12 Oct 2021
- Last updated
- 24 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expressing Personal Recollections in English or Spanish to Alleviate Traumatic Emotions (Exprésate)
- ClinicalTrials.gov ID
- NCT05090839
- Acronym / sponsor ID
- Exprésate / 20190760
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 2 Dec 2023 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Posted 24 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Augmented trauma-writing intervention in Spanish | Experimental | Behavioral: Weekly Emotional Disclosure (WED) SpanishParticipants 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. |
| Augmented trauma-writing intervention in English | Experimental | Behavioral: Weekly Emotional Disclosure (WED)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. |
| Daily-event-writing control in English | Active comparator | Behavioral: Weekly Emotional Disclosure (WED)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." |
| Daily-event-writing control in Spanish | Active comparator | Behavioral: Weekly Emotional Disclosure (WED) SpanishParticipants 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." |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Augmented trauma-writing intervention in English, Daily-event-writing control in English |
| Weekly Emotional Disclosure (WED) SpanishOnline 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. | Behavioural | Augmented trauma-writing intervention in Spanish, Daily-event-writing control in Spanish |
Primary outcome
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.
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).
2 secondary outcomes
Change in Functional Activity of the Default Mode Network (DMN).
Time frame: 6 weeks
Change in Salivary Measures of Stress Reactivity.
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger McIntosh principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly Emotional Disclosure (WED) and Weekly Emotional Disclosure (WED) Spanish in people with Post Traumatic Stress Disorder, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD Symptoms as Assessed by the Impact of Event Scale (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.