Clinical trial NCT05090839: Expressing Personal Recollections in English or Spanish to Alleviate Traumatic Emotions (Exprésate)
Official title: Expressing Personal Recollections in English or Spanish to Alleviate Traumatic Emotions (Exprésate)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Center for Latino Health Research Opportunities
First posted: 2021-10-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in PTSD symptoms as assessed by the Impact of Event Scale and/or the PCL5
timeFrame: Baseline, 6 weeks
measure: Assess change in gene expression for FKBP5, NFkB, & CTRA
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Changes in limbic system response to traumatic memory recall & verbal learning & recall.
timeFrame: Baseline, 6 weeks
measure: Change in salivary alpha amylase (sAA) levels & change in salivary adrenal corticotrophin releasing hormone (ACTH) levels
timeFrame: Baseline, 6 weeks
measure: Change in dexamethasone suppression of peripheral mononuclear cells.
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Roger McIntosh
role: PRINCIPAL_INVESTIGATOR
References: