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

Not Applicable

Completed

• Conditions: Post Traumatic Stress Disorder

• Registration Number: NCT05090839
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-18
• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-25
• Primary Completion: 2023-02-01
• Study Completion: 2023-12-02
• Results First Submitted: 2025-03-24
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Results First Posted: 2025-08-24
• Last Update Posted: 2025-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in PTSD Symptoms as Assessed by the Impact of Event Scale	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	baseline	Measures verbal learning and memory function based on the initial word learning list (0 no words recalled - 12 all words recalled).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States