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

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

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

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Weekly Emotional Disclosure (WED)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 21 years 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 On a stable anti-retroviral therapy regimen for > 6 months as assessed with the Adult AIDS Clinical Trial Group structured interview Spanish-English bilingual as measured by the Brief Acculturation Scale for Hispanics (cut-off of 3), Spanish speaker or English speaker Participant is willing and able to sign Informed Consent Form (ICF) self-report as Latina HIV positive serostatus as determined by medical record within the last 12 months Born female. Exclusion Criteria: Left-handedness or ambidextrous Inability to tolerate the scanning procedures Metal in body or prior history working with metal fragments Any other contraindications for MRI examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body) currently pregnant or could be pregnant Heavy alcohol intake (> 3 drinks) within 12 hours prior to participation in Functional Magnetic Resonance Imaging (fMRI) Evidence from health history of neurological or systemic disorder which can cause cognitive impairment Self-reported current diagnosis of psychiatric disorder or psychoactive substance abuse or dependence Recent history (within two years) of myocardial infarction Severe cardiovascular disease, or currently active cardiovascular disease (e.g., angina, cardiomyopathy) Uncontrolled hypertension or hypotension History of closed trauma with loss of consciousness Space occupying lesions (e.g., mass lesions, tumors) Central Nervous System (CNS) infection CNS vasculitis CNS demyelinating disease (e.g., multiple sclerosis) Congenital CNS abnormality (e.g., cerebral palsy) Seizure disorders History of cerebrovascular disease (e.g., stroke, TIA's)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spanish-Only Writing Group<br>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 Spanish only. | Behavioral: Weekly Emotional Disclosure (WED)<br>* 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.<br>|
| Experimental: English-Only Writing Group<br>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 English only. | Behavioral: Weekly Emotional Disclosure (WED)<br>* 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.<br>|
| Experimental: Non-Trauma Daily Event Writing in Spanish Group<br>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 Spanish only. | Behavioral: Weekly Emotional Disclosure (WED)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PTSD symptoms as assessed by the Impact of Event Scale | 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 | 
| Change in verbal learning as assessed by Hopkins Verbal Learning Task (HVLT) | HVLT measures verbal learning and memory function. It is scored based on the total number of words recalled in 3 immediate trials with scores ranging from 0 (no words recalled) to 48 (all 12 words recalled after each of the trials) | Baseline, 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional connectivity of the Default Mode Network (DMN) | DMN is a large scale network of interacting brain regions implicated in emotion and memory. Activity/connectivity indexed by Fisher's Z or Beta wt using fMRI. | Baseline, 6 weeks | 
| Change in salivary alpha amylase (sAA) levels | As assessed from saliva samples | Baseline, 6 weeks | 
| Change in salivary adrenal corticotrophin releasing hormone (ACTH) levels | As assessed from saliva samples | Baseline, 6 weeks |