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

University of Miami

Status: Completed

Conditions: Post Traumatic Stress Disorder

Treatments: Behavioral: Weekly Emotional Disclosure (WED)

Study type: Interventional

Funder types: Other

Identifiers

NCT05090839

20190760

Details and patient eligibility

About

The purpose of this study is to test if expressive writing about traumatic events has positive changes in women living with post-traumatic stress.

Enrollment: 40 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Spanish-Only Writing Group

Active Comparator group

Description:

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. The participant will be required to write in their preferred language (English or Spanish).

Treatment:

Behavioral: Weekly Emotional Disclosure (WED)

English-Only Writing Group

Experimental group

Description:

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). The participant will be required to write in their preferred language (English or Spanish).

Treatment:

Behavioral: Weekly Emotional Disclosure (WED)