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

University of Washington

Status: Completed

Conditions: Post Traumatic Stress Disorder; Problem Drinking

Treatments: Behavioral: App-based intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03703258

R00AA026317 (U.S. NIH Grant/Contract)

STUDY00005025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Intervention

Experimental group

Description:

The THRIVE app involves 3 weeks of daily activities. Day 1 involves identification of activities to add to a "self-care activity list" with guidance around selecting activities that increase social contact, reduce alcohol use, and reduce avoidance. They will also complete an active-learning exercise about cognitive distortions and create a "stuck point to-do list" consisting of their cognitive distortions. In subsequent days, participants will be prompted to complete activities from both lists. They will also have access optional activities on topics such as asking for help, preventing isolation, deciding whether to disclose an assault, coping with negative reactions to disclosure, and thinking in helpful ways about social support. They will be prompted to complete brief daily surveys in the app, which will populate a symptom tracker. Participants in will have brief weekly phone contact with a coach to monitor safety and troubleshoot issues with app use.

Treatment:

Behavioral: App-based intervention

Assessment-only control

No Intervention group

Description:

The assessment-only control condition will involve access to a version of the app that includes daily surveys and a symptom tracker populated by these surveys, but without any of the other exercises included in the experimental version of the app. Participants in the control condition will have brief weekly phone contact with a coach to monitor safety and troubleshoot issues with app use.