CompletedNot Applicable

Brief Restructuring Intervention Following Trauma Exposure

United States57 participantsStarted 2015-03-01

Plain-language summary

The broad aim of this study is to develop and test a brief intervention that can be implemented in the immediate weeks following sexual assault to decrease likelihood of developing posttraumatic stress disorder (PTSD) or alcohol misuse. The first phase of the study will enroll 6 women to complete a brief, cognitive therapy protocol and provide feedback on the intervention (open trial). The second phase of the study will recruit 76 women to complete either the intervention (38 women) or assessment only (38 women) to test the effects of the intervention on both PTSD symptoms and alcohol use behavior as compared to natural recovery following assault.

Who can participate

Age range

18 Years

Sex

ALL

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 * Age \> 18 years * 2-10 weeks post sexual assault * PTSD symptoms related to recent sexual assault, specifically defined as a minimum of 1 reexperiencing, 1 avoidance, 2 negative alterations in mood/cognition, or 2 hyperarousal symptoms * Drinking more than 3 drinks on one occasion in the last month and at least two reported negative consequences of alcohol use * Capacity to provide informed consent * English fluency * No planned absences that they would be unable to complete 5 weeks of assessments and coaching calls * Access to a telephone. Exclusion Criteria: * Acutely suicidal with intent/plan * Exhibit current psychosis * Previous non-response to an adequate trial (8 or more sessions) of Cognitive Processing Therapy (CPT)

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

Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I)

Timeframe: 12 weeks

Timeline Followback Heavy Episodic Drinking Episodes

Timeframe: 12 weeks

Trial details

NCT IDNCT02808468

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02

Results submitted2024-10-21

View on ClinicalTrials.gov More Posttraumatic Stress Disorder trials