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

Post Traumatic Stress Disorder Clinical Trial

— Exprésate  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05090839
• Other study ID #: 20190760
• Status: Completed
• Phase: N/A
• Start date: August 18, 2021
• Est. completion date: December 2, 2023

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Weekly Emotional Disclosure (WED)
Online writing session with each session lasting approximately 30 minutes. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Center for Latino Health Research Opportunities

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD symptoms as assessed by the Impact of Event Scale and/or the PCL5	Post Traumatic Stress Disorder (PTSD) symptoms will be assessed via the Impact of Event Scale (IES). IES is a 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. The IES has a total score ranging from 0 to 88 with the higher score indicating greater PTSD symptoms.	Baseline, 6 weeks
Primary	Assess change in gene expression for FKBP5, NFkB, & CTRA	Assess changes in whole blood RNA expression of genes which code for HPA-axis activity (FKBPG), pro-inflammatory response (NFkB), and conserved transcriptional response to adversity (CTRA).	Baseline, 6 weeks
Secondary	Changes in limbic system response to traumatic memory recall & verbal learning & recall.	Change in BOLD response of ventromedial prefrontal cortex, amygdala, and hippocampus (regions involved in emotion and memory). Activity indexed by Fisher's Z or Beta wt using fMRI for the trauma recall task and verbal learning and memory task before and after the intervention.	Baseline, 6 weeks
Secondary	Change in salivary alpha amylase (sAA) levels & change in salivary adrenal corticotrophin releasing hormone (ACTH) levels	As assessed from saliva samples	Baseline, 6 weeks
Secondary	Change in dexamethasone suppression of peripheral mononuclear cells.	Assessed from peripheral blood, the propensity for immune cells to release pro-inflammatory cytokines in response to LPS stimulation.	Baseline, 6 weeks