Understanding and Testing Recovery Processes for PTSD and Alcohol Use Following Sexual Assault (NCT04124380) | Clinical Trial Compass
CompletedNot Applicable
Understanding and Testing Recovery Processes for PTSD and Alcohol Use Following Sexual Assault
United States82 participantsStarted 2021-06-02
Plain-language summary
Sexual assault can lead to devastating consequences including the development of chronic conditions including posttraumatic stress disorder (PTSD) and alcohol use disorders (AUD). Interventions delivered soon after exposure to assault can decrease the long-term negative consequences of sexual assault but existing interventions are limited in their ability to target concurrent PTSD symptoms and alcohol use and little is known about how to make best practice treatment decisions in the early period following sexual assault. A greater emphasis on transdiagnostic processes that are related to both PTSD and alcohol use, such as fear and reward systems, can elucidate mechanisms of recovery, lead to the development of more effective intervention approaches, and guide clinical decision making for patients recently exposed to sexual assault.
Who can participate
Age range
18 Years – 65 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
. Identifies as female.
. Between the age of 18 and 65.
. Reports a sexual assault in the last 4 weeks to 1 year.
. Current PTSD severity of 23+ on the PSS-I-5.
. Current heavy alcohol use (2+ heavy episodic drinking occasions \[4+ drinks on one occasion\] in past month).
. Access to the internet and a device with a webcam.
Exclusion criteria
. Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-5.
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.
. Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).
. Unwilling or unable to discontinue current trauma-focused psychotherapy or current substance use psychotherapy.
. Unstable dose of psychotropic medications in the prior 3 months.
. Ongoing intimate relationship with the perpetrator of most recent assault.
. Current diagnosis of a severe substance use disorder according to DSM-5, other than alcohol in the last month.
. No clear trauma memory.
. Current higher dose use of benzodiazepines (greater than the equivalent of 4 mg of lorazepam, 2 mg alprazolam, 1.5 mg clonazepam, or 20 mg of diazepam).