Tools for Health and Resilience Implemented After Violence Exposure (Project THRIVE) (NCT03703258) | Clinical Trial Compass
CompletedNot Applicable
Tools for Health and Resilience Implemented After Violence Exposure (Project THRIVE)
United States41 participantsStarted 2021-01-13
Plain-language summary
Sexual assault victimization is a common and particularly harmful form of trauma that is associated with increased risk for high-risk drinking and other conditions of public health concern, such as PTSD. Given evidence that sexual assault survivors who have low social support or receive negative social reactions to sexual assault disclosure are more likely to experience PTSD and drinking problems, improving social support is a novel target for intervention. The proposed study will attempt to prevent the onset of high-risk drinking and PTSD in sexual assault survivors by developing and testing a web-based early intervention aimed at increasing contact with social supporters and mitigating the harm of negative social reactions; ultimately, results will contribute to advancing the field's understanding of the potential for social support to mitigate the harm of trauma.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* informed consent
* self-identification as female
* sexual assault, defined as endorsement of unwanted, attempted or completed sexual contact in the past 10 weeks
* age \> 18
* English fluency
* smartphone and internet access at least daily for 3 weeks and at least weekly for 3 months
* consumption of \>1 alcoholic drink in the past month
* \>1 episode of high-risk drinking in past 6 months, defined as either more than 3 drinks on a given day or more than 7 drinks in a given week
* at least 3 symptom clusters endorsed on the PTSD Checklist.
Exclusion Criteria:
* active suicidality
* psychosis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Problem Drinking Scores at Baseline and 3 Weeks
Timeframe: Baseline, post-intervention (3 weeks after baseline)
2
Problem Drinking Scores at Baseline and 3 Months
Timeframe: Baseline, 3 month follow-up
3
Posttraumatic Stress Symptom Severity Score at Baseline and 3 Weeks
Timeframe: Baseline, post-intervention (3 weeks after baseline)
4
Posttraumatic Stress Symptom Severity Score at Baseline and 3 Months