Clinical Trials Directory

Trials / Completed

CompletedNCT03703258

Tools for Health and Resilience Implemented After Violence Exposure (Project THRIVE)

Preventing Risky Drinking and PTSD After Sexual Assault: A Web-Based Intervention

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
41 (actual)
Sponsor
University of Washington · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

This study involves developing, modifying, and preliminarily testing an intervention to prevent high-risk drinking and PTSD in women who have experienced sexual assault (SA) in the past 10 weeks. In the pilot trial phase of this study, intervention feasibility will be tested in an open trial with N = 40 women with past-10-week SA histories, active drinking, and elevated distress. Participants will complete surveys at baseline, termination, and 3-month follow-up. Participants will be randomized to either the intervention (N = 20) or assessment-only control (N = 20). We hypothesize that (H1) most participants will respond positively on items assessing satisfaction with the intervention, (H2) participants will report above-average usability on a standardized measure, (H3) completion rates for daily activities will be similar to previous web-based interventions, (H4) participants will show significant learning as evidenced by increases in correct responses to knowledge questions from baseline to post, and (H5) participants in the intervention condition will evidence less high-risk drinking and PTSD at 3-month follow-up than participants in the assessment-only condition.

Conditions

Interventions

TypeNameDescription
BEHAVIORALApp-based interventionA app-based cognitive-behavioral intervention to prevent the development of PTSD and high-risk drinking in recently-victimized adults

Timeline

Start date
2021-01-13
Primary completion
2021-08-24
Completion
2021-11-20
First posted
2018-10-11
Last updated
2022-12-02
Results posted
2022-12-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03703258. Inclusion in this directory is not an endorsement.