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

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03703258
• Other study ID #: STUDY00005025
• Secondary ID: R00AA026317
• Status: Completed
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: November 20, 2021

Study information

• Verified date: November 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 20, 2021
• Est. primary completion date: August 24, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Problem Drinking
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• App-based intervention
A app-based cognitive-behavioral intervention to prevent the development of PTSD and high-risk drinking in recently-victimized adults

Locations

Country	Name	City	State
United States	University of Washington School of Medicine	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Problem Drinking Scores at Baseline and 3 Weeks	Sum scores on Rutgers Alcohol Problem Index- Short Form (RAPI-S), which assesses alcohol use consequences. Range: 0-64; higher scores indicate worse outcome.	Baseline, post-intervention (3 weeks after baseline)
Primary	Problem Drinking Scores at Baseline and 3 Months	Sum scores on Rutgers Alcohol Problem Index- Short Form (RAPI-S), which assesses alcohol use consequences. Range: 0-64; higher scores indicate worse outcome.	Baseline, 3 month follow-up
Primary	Posttraumatic Stress Symptom Severity Score at Baseline and 3 Weeks	Sum scores on the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5), which assesses posttraumatic stress symptom severity. Range: 0-80; higher scores indicate worse outcome.	Baseline, post-intervention (3 weeks after baseline)
Primary	Posttraumatic Stress Symptom Severity Score at Baseline and 3 Months	Sum scores on the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5), which assesses posttraumatic stress symptom severity. Range: 0-80; higher scores indicate worse outcome.	Baseline, 3 month follow-up
Secondary	Anxiety	Sum scores on Generalized Anxiety Disorder-7 (GAD-7), which assesses symptoms of anxiety. Range: 0-21; higher scores indicate worse outcome.	Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Secondary	Coping Self-efficacy	Mean scores on the Trauma Coping Self-Efficacy Scale (CSE-T), which assesses one's perceived ability to manage the demands of recovering from a potentially-traumatic event. Range: 1 to 7; higher scores indicate better outcome.	Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Secondary	Depression	Sum scores on the Patient Health Questionnaire-8 (PHQ-8), which assesses symptoms of depression. Range: 0-24; higher scores indicate worse outcome.	Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Secondary	Alcohol Consumption (Quantity)	Number of drinks per week reported on the Daily Drinking Questionnaire	Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Secondary	Alcohol Consumption (Frequency)	Number of drinking days per week reported on the Daily Drinking Questionnaire	Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Secondary	Alcohol Consumption (Hours)	Hours spent drinking per week reported on the Daily Drinking Questionnaire	Baseline, post-intervention (3 weeks after baseline), 3 month follow-up