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| ID | Type | Description | Link |
|---|---|---|---|
| 5U54MD002266-15 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Augmented trauma-writing intervention in Spanish | Experimental | 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. |
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| Augmented trauma-writing intervention in English | Experimental | 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. |
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| Daily-event-writing control in English | Active Comparator | 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." |
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| Daily-event-writing control in Spanish | Active Comparator | 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." |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weekly Emotional Disclosure (WED) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| 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). | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger McIntosh | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33143 | United States |
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
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2 years, 4 months
Participants were provided with a measurement of SUDS (distress scale) before and after each session. This data and self-report was monitored for adverse effects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roger McIntosh | University of Miami | 3052435166 | r.mcintosh@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2022 | Mar 11, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 17, 2021 | Mar 14, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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|
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| Weekly Emotional Disclosure (WED) Spanish | Behavioral | 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. |
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| 6 weeks |
| 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 | 6 weeks |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
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| 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). | 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. | Posted | Mean | Standard Deviation | Total words recalled following delay. | baseline |
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|
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| 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. | 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.) | Posted | Mean | Standard Deviation | Beta-weight reflecting change in BOLD | 6 weeks |
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| 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 | 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. | Posted | Mean | Standard Deviation | picograms per milliliter | 6 weeks |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | 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. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | 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. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG003 | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
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