Clinical trial NCT03703258: Tools for Health and Resilience Implemented After Violence Exposure (Project THRIVE)
Official title: Preventing Risky Drinking and PTSD After Sexual Assault: A Web-Based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Problem Drinking
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-10-11
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Problem Drinking Scores at Baseline and 3 Weeks
timeFrame: Baseline, post-intervention (3 weeks after baseline)
measure: Problem Drinking Scores at Baseline and 3 Months
timeFrame: Baseline, 3 month follow-up
measure: Posttraumatic Stress Symptom Severity Score at Baseline and 3 Weeks
timeFrame: Baseline, post-intervention (3 weeks after baseline)
measure: Posttraumatic Stress Symptom Severity Score at Baseline and 3 Months
timeFrame: Baseline, 3 month follow-up
Secondary outcomes:
measure: Anxiety
timeFrame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
measure: Coping Self-efficacy
timeFrame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
measure: Depression
timeFrame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
measure: Alcohol Consumption (Quantity)
timeFrame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
measure: Alcohol Consumption (Frequency)
timeFrame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
measure: Alcohol Consumption (Hours)
timeFrame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
Study officials:
affiliation: University of Washington
name: Emily Dworkin, PhD
role: PRINCIPAL_INVESTIGATOR
References: