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Completed

NCT Number: NCT03703258

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

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.

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Key information

Conditions

Post Traumatic Stress Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Problem Drinking Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington School of Medicine

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

App-based intervention

Behavioral

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

Other names: THRIVE app

Primary outcomes

  1. Problem Drinking Scores at Baseline and 3 Weeks

    Time frame: Baseline, post-intervention (3 weeks after baseline)

    Sum scores on Rutgers Alcohol Problem Index- Short Form (RAPI-S), which assesses alcohol use consequences. Range: 0-64; higher scores indicate worse outcome.

  2. Problem Drinking Scores at Baseline and 3 Months

    Time frame: Baseline, 3 month follow-up

    Sum scores on Rutgers Alcohol Problem Index- Short Form (RAPI-S), which assesses alcohol use consequences. Range: 0-64; higher scores indicate worse outcome.

  3. Posttraumatic Stress Symptom Severity Score at Baseline and 3 Weeks

    Time frame: Baseline, post-intervention (3 weeks after baseline)

    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.

  4. Posttraumatic Stress Symptom Severity Score at Baseline and 3 Months

    Time frame: Baseline, 3 month follow-up

    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.

Secondary outcomes

  1. Anxiety

    Time frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up

    Sum scores on Generalized Anxiety Disorder-7 (GAD-7), which assesses symptoms of anxiety. Range: 0-21; higher scores indicate worse outcome.

  2. Coping Self-efficacy

    Time frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up

    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.

  3. Depression

    Time frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up

    Sum scores on the Patient Health Questionnaire-8 (PHQ-8), which assesses symptoms of depression. Range: 0-24; higher scores indicate worse outcome.

  4. Alcohol Consumption (Quantity)

    Time frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up

    Number of drinks per week reported on the Daily Drinking Questionnaire

  5. Alcohol Consumption (Frequency)

    Time frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up

    Number of drinking days per week reported on the Daily Drinking Questionnaire

  6. Alcohol Consumption (Hours)

    Time frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up

    Hours spent drinking per week reported on the Daily Drinking Questionnaire

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 11, 2018
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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