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: 2023-12-01
• Study Completion: 2023-12-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15

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
Assess change in gene expression for FKBP5, NFkB, & CTRA	Baseline, 6 weeks	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).
Change in PTSD symptoms as assessed by the Impact of Event Scale and/or the PCL5	Baseline, 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in salivary alpha amylase (sAA) levels & change in salivary adrenal corticotrophin releasing hormone (ACTH) levels	Baseline, 6 weeks	As assessed from saliva samples
Change in dexamethasone suppression of peripheral mononuclear cells.	Baseline, 6 weeks	Assessed from peripheral blood, the propensity for immune cells to release pro-inflammatory cytokines in response to LPS stimulation.
Changes in limbic system response to traumatic memory recall & verbal learning & recall.	Baseline, 6 weeks	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.

Trial Locations

Locations (1)

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