Post Traumatic Stress Disorder
Conditions
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.
Interventions
BEHAVIORALWeekly Emotional Disclosure (WED)
Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day.
BEHAVIORALWeekly Emotional Disclosure (WED) Spanish
Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day in Spanish.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PTSD Symptoms as Assessed by the Impact of Event Scale | 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 | baseline | Measures verbal learning and memory function based on the initial word learning list (0 no words recalled - 12 all words recalled). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Activity of the Default Mode Network (DMN). | 6 weeks | DMN is a large-scale network of interacting brain regions implicated in emotion and memory. Activity of the DMN hub indexed by Beta weight of activity within the ventral medial prefrontal cortex (VMPFC) was compared as a contrast between the visualizing trauma vs. visualizing stress conditions of the exposure. The VMPFC hub of the default mode network is a region integral to emotion regulation and is shown to be active during the use of cognitive-emotional regulation tasks (Andrewes and Jenkins, 2019). Hence, a randomization related increase in VMPFC activity while processing traumatic memories is associated with greater task engagement and cognitive-emotion regulation, which is a positive outcome. |
| Change in Salivary Measures of Stress Reactivity. | 6 weeks | 200 uL of saliva will be used for immunosorbent assay of salivary alpha amylase (sAA) measured by picograms per milliliter |
Countries
United States
Participant flow
Recruitment details
Participants were recruited by flyers presented at community locations such as outpatient clinics, women's shelters, and at research centers located on the campus of the University of Miami.
Pre-assignment details
Of the 40 participants enrolled, incomplete data collection resulted in 5 participants not being randomized and 6 were loss to follow-up prior to randomization. Thus, a total of 11 enrolled participants were not randomized.
Participants by arm
| Arm | Count |
|---|---|
| Augmented Trauma-writing Intervention in Spanish 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 in Spanish.
Weekly Emotional Disclosure (WED) Spanish Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day in Spanish. | 11 |
| Augmented Trauma-writing Intervention in English 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) in English.
Weekly Emotional Disclosure (WED) Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day. | 7 |
| Daily-event-writing Control in English Participants in this group will be asked to conduct event writing condition in English and will be asked to write a description about what they did yesterday from the time \[they\] got up until the time \[they\] went to bed for 20 min continuously. They will be told to avoid writing about \[their\] emotions or opinions but to try to be as accurate and objective as possible.
Weekly Emotional Disclosure (WED) Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day. | 5 |
| Daily-event-writing Control in Spanish Participants in this group will be asked to conduct event writing in condition in Spanish and will be asked to write a description about what they did yesterday from the time \[they\] got up until the time \[they\] went to bed for 20 min continuously. They will be told to avoid writing about \[their\] emotions or opinions but to try to be as accurate and objective as possible.
Weekly Emotional Disclosure (WED) Spanish Online writing sessions, each lasting approximately 45 minutes, once a week, conducted virtually. Participants will be instructed to write about either a major traumatic life experience or what the participant did the previous day in Spanish. | 6 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 | 1 | 1 |
Baseline characteristics
| Characteristic | Augmented Trauma-writing Intervention in Spanish | Augmented Trauma-writing Intervention in English | Daily-event-writing Control in English | Daily-event-writing Control in Spanish | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 7 Participants | 5 Participants | 6 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 6 Participants | 5 Participants | 6 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 6 Participants | 5 Participants | 6 Participants | 28 Participants |
| Sex: Female, Male Female | 11 Participants | 7 Participants | 5 Participants | 6 Participants | 29 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 7 | 0 / 5 | 0 / 6 |
| other Total, other adverse events | 0 / 11 | 0 / 7 | 0 / 5 | 0 / 6 |
| serious Total, serious adverse events | 0 / 11 | 0 / 7 | 0 / 5 | 0 / 6 |
Outcome results
Primary
Change in PTSD Symptoms as Assessed by the Impact of Event Scale
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.
Time frame: 6 weeks
Population: Data not analyzed from 19 participants that either did not complete a baseline or follow-up assessment of IES or who were lost to follow-up during the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Augmented Trauma-writing Intervention in Spanish | Change in PTSD Symptoms as Assessed by the Impact of Event Scale | -.383 score on a scale | Standard Deviation 12.19 |
| Augmented Trauma-writing Intervention in English | Change in PTSD Symptoms as Assessed by the Impact of Event Scale | 6.43 score on a scale | Standard Deviation 4.27 |
| Daily-event-writing Control in English | Change in PTSD Symptoms as Assessed by the Impact of Event Scale | -3.18 score on a scale | Standard Deviation 16.22 |
| Daily-event-writing Control in Spanish | Change in PTSD Symptoms as Assessed by the Impact of Event Scale | -2.11 score on a scale | Standard Deviation 9.59 |
p-value: <0.0595% CI: [0, 0.234]ANOVA
Primary
Changes in Verbal Learning as Assessed by Hopkins Verbal Learning Task
Measures verbal learning and memory function based on the initial word learning list (0 no words recalled - 12 all words recalled).
Time frame: baseline
Population: Data could not be collected at both timepoints due to time restraints and participant burden during. Hence, there was only one assessment of delayed recall performance on the HVLT.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Augmented Trauma-writing Intervention in Spanish | Changes in Verbal Learning as Assessed by Hopkins Verbal Learning Task | 10.43 Total words recalled following delay. | Standard Deviation 1.272 |
| Augmented Trauma-writing Intervention in English | Changes in Verbal Learning as Assessed by Hopkins Verbal Learning Task | 11.67 Total words recalled following delay. | Standard Deviation 0.577 |
| Daily-event-writing Control in English | Changes in Verbal Learning as Assessed by Hopkins Verbal Learning Task | 12 Total words recalled following delay. | Standard Deviation 0 |
| Daily-event-writing Control in Spanish | Changes in Verbal Learning as Assessed by Hopkins Verbal Learning Task | 9.80 Total words recalled following delay. | Standard Deviation 1.92 |
Secondary
Change in Functional Activity of the Default Mode Network (DMN).
DMN is a large-scale network of interacting brain regions implicated in emotion and memory. Activity of the DMN hub indexed by Beta weight of activity within the ventral medial prefrontal cortex (VMPFC) was compared as a contrast between the visualizing trauma vs. visualizing stress conditions of the exposure. The VMPFC hub of the default mode network is a region integral to emotion regulation and is shown to be active during the use of cognitive-emotional regulation tasks (Andrewes and Jenkins, 2019). Hence, a randomization related increase in VMPFC activity while processing traumatic memories is associated with greater task engagement and cognitive-emotion regulation, which is a positive outcome.
Time frame: 6 weeks
Population: Data not analyzed from 23 participants that either did not complete a baseline or follow-up fMRI assessment, or who's data could not be analyzed due to fMRI data not passing quality control (e.g., excessive motion, did not finish scan, signal distortion, etc.)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Augmented Trauma-writing Intervention in Spanish | Change in Functional Activity of the Default Mode Network (DMN). | .702 Beta-weight reflecting change in BOLD | Standard Deviation 0.858 |
| Augmented Trauma-writing Intervention in English | Change in Functional Activity of the Default Mode Network (DMN). | -.716 Beta-weight reflecting change in BOLD | Standard Deviation 0.906 |
| Daily-event-writing Control in English | Change in Functional Activity of the Default Mode Network (DMN). | -.225 Beta-weight reflecting change in BOLD | Standard Deviation 0.543 |
| Daily-event-writing Control in Spanish | Change in Functional Activity of the Default Mode Network (DMN). | -.118 Beta-weight reflecting change in BOLD | Standard Deviation 0.762 |
Comparison: This is a comparison that is specific to the contrast of visualizing traumatic versus stressful events.p-value: <0.0595% CI: [0, 0.554]ANOVA
Secondary
Change in Salivary Measures of Stress Reactivity.
200 uL of saliva will be used for immunosorbent assay of salivary alpha amylase (sAA) measured by picograms per milliliter
Time frame: 6 weeks
Population: Data not analyzed from 29 participants that either did not complete a baseline or follow-up saliva collection or associated trauma recall tasks, were lost to follow-up during the intervention, had missing data from 1 of the three salivary time collection points, or samples not correctly recorded or collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Augmented Trauma-writing Intervention in Spanish | Change in Salivary Measures of Stress Reactivity. | -871.9 picograms per milliliter | — |
| Augmented Trauma-writing Intervention in English | Change in Salivary Measures of Stress Reactivity. | -250.87 picograms per milliliter | Standard Deviation 11.9 |
| Daily-event-writing Control in English | Change in Salivary Measures of Stress Reactivity. | -622.3 picograms per milliliter | Standard Deviation 487.1 |
| Daily-event-writing Control in Spanish | Change in Salivary Measures of Stress Reactivity. | -129.53 picograms per milliliter | Standard Deviation 267.15 |
p-value: <0.0595% CI: [0, 0.676]ANOVA