Expressing Personal Recollections in English or Spanish to Alleviate Traumatic Emotions (Exprésate)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Change in PTSD Symptoms as Assessed by the Impact of Event Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Change in PTSD Symptoms as Assessed by the Impact of Event Scale
Time Frame: 6 weeks
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 on a scale from 0 (not at all) to 4 (extremely) The IES has a total score ranging from 0 to 88 with the higher score indicating greater PTSD symptoms. The IES was assessed before and after the intervention and the change in score (mean and SD) is reported as the outcome measure.
Changes in Verbal Learning as Assessed by Hopkins Verbal Learning Task
Time Frame: baseline
Measures verbal learning and memory function based on the initial word learning list (0 no words recalled - 12 all words recalled).
Secondary Outcomes
- Change in Functional Activity of the Default Mode Network (DMN).(6 weeks)
- Change in Salivary Measures of Stress Reactivity.(6 weeks)
Investigators
Roger McIntosh
Associate Professor
University of Miami