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

NCT03703258 | Completed Results

• 2 other identifiers: STUDY00005025R00AA026317
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder; Problem Drinking

Outcome Measures

Primary Outcomes (4)

• 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)

• 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

• 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)

• 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 Outcomes (6)

• Anxiety

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

• Coping Self-efficacy

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

• Depression

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

• Alcohol Consumption (Quantity)

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

• Alcohol Consumption (Frequency)

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

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: App-based intervention

Assessment-only control

NO INTERVENTION

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.

Interventions

App-based intervention BEHAVIORAL

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

Also known as: THRIVE app

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants who self-identify as female are eligible to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• active suicidality
• psychosis

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Washington School of Medicine

Seattle, Washington, 98105, United States

Location

Related Publications (4)

• Howe ES, Dworkin ER. The day-to-day relationship between posttraumatic stress symptoms and social support after sexual assault. Eur J Psychotraumatol. 2024;15(1):2311478. doi: 10.1080/20008066.2024.2311478. Epub 2024 Feb 20.

  PMID: 38376992 DERIVED

• O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.

  PMID: 37795783 DERIVED

• Dworkin ER, Schallert M, Lee CM, Kaysen D. mHealth Early Intervention to Reduce Posttraumatic Stress and Alcohol Use After Sexual Assault (THRIVE): Feasibility and Acceptability Results From a Pilot Trial. JMIR Form Res. 2023 Jul 4;7:e44400. doi: 10.2196/44400.

  PMID: 37402144 DERIVED

• Dworkin ER, Schallert M, Lee CM, Kaysen D. Pilot randomized clinical trial of an app-based early intervention to reduce PTSD and alcohol use following sexual assault. Psychol Trauma. 2024 Dec;16(Suppl 3):S668-S678. doi: 10.1037/tra0001460. Epub 2023 Apr 3.

  PMID: 37011153 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Alcoholism

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Results Point of Contact

• Title: Dr. Emily R. Dworkin
• Organization: University of Washington School of Medicine

edworkin@uw.edu

206-221-6932

Study Officials

• Emily Dworkin, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Assistant Professor, School of Medicine: Psychiatry

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: October 11, 2018
• Study Start: January 13, 2021
• Primary Completion: August 24, 2021
• Study Completion: November 20, 2021
• Last Updated: December 2, 2022
• Results First Posted: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)