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

Primary Purpose

Post Traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weekly Emotional Disclosure (WED)
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Traumatic Stress Disorder

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Spanish-Only Writing Group

English-Only Writing Group

Non-Trauma Daily Event Writing in Spanish Group

Arm 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 Spanish only.

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.

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.

Outcomes

Primary Outcome Measures

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.
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)

Secondary Outcome Measures

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.
Change in salivary alpha amylase (sAA) levels
As assessed from saliva samples
Change in salivary adrenal corticotrophin releasing hormone (ACTH) levels
As assessed from saliva samples

Full Information

First Posted
October 12, 2021
Last Updated
August 30, 2023
Sponsor
University of Miami
Collaborators
Center for Latino Health Research Opportunities
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1. Study Identification

Unique Protocol Identification Number
NCT05090839
Brief Title
Expressing Personal Recollections in English or Spanish to Alleviate Traumatic Emotions (Exprésate)
Acronym
Exprésate
Official Title
Expressing Personal Recollections in English or Spanish to Alleviate Traumatic Emotions (Exprésate)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Center for Latino Health Research Opportunities

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spanish-Only Writing Group
Arm Type
Experimental
Arm 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 Spanish only.
Arm Title
English-Only Writing Group
Arm Type
Experimental
Arm 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 English only.
Arm Title
Non-Trauma Daily Event Writing in Spanish Group
Arm Type
Experimental
Arm 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 Spanish only.
Intervention Type
Behavioral
Intervention Name(s)
Weekly Emotional Disclosure (WED)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in PTSD symptoms as assessed by the Impact of Event Scale
Description
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.
Time Frame
Baseline, 6 weeks
Title
Change in verbal learning as assessed by Hopkins Verbal Learning Task (HVLT)
Description
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)
Time Frame
Baseline, 6 weeks
Secondary Outcome Measure Information:
Title
Change in functional connectivity of the Default Mode Network (DMN)
Description
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.
Time Frame
Baseline, 6 weeks
Title
Change in salivary alpha amylase (sAA) levels
Description
As assessed from saliva samples
Time Frame
Baseline, 6 weeks
Title
Change in salivary adrenal corticotrophin releasing hormone (ACTH) levels
Description
As assessed from saliva samples
Time Frame
Baseline, 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roger McIntosh
Phone
305-243-2047
Email
r.mcintosh@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger McIntosh
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger McIntosh
Phone
305-243-2047
Email
r.mcintosh@miami.edu
First Name & Middle Initial & Last Name & Degree
Roger McIntosh

12. IPD Sharing Statement

Plan to Share IPD
No

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

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