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

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ClinicalTrials.gov Identifier: NCT03703258
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : January 22, 2021
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Emily Dworkin, University of Washington

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.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Problem Drinking Behavioral: App-based intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Risky Drinking and PTSD After Sexual Assault: A Web-Based Intervention
Actual Study Start Date : January 13, 2021
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : September 1, 2023

Arm Intervention/treatment
Experimental: Intervention
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
A app-based cognitive-behavioral intervention to prevent the development of PTSD and high-risk drinking in recently-victimized adults
Other Name: THRIVE app

No Intervention: Assessment-only control
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.



Primary Outcome Measures :
  1. Change in problem drinking at 3 weeks [ Time Frame: Baseline, post-intervention (3 weeks after baseline) ]
    Sum scores on Rutgers Alcohol Problem Index- Short Form (RAPI-S). Range: 0-64; higher scores indicate worse outcome.

  2. Change in problem drinking at 3 months [ Time Frame: Baseline, 3 month follow-up ]
    Sum scores on Rutgers Alcohol Problem Index- Short Form (RAPI-S). Range: 0-64; higher scores indicate worse outcome.

  3. Change in posttraumatic stress symptoms at 3 weeks [ Time Frame: Baseline, post-intervention (3 weeks after baseline) ]
    Sum scores on PTSD Checklist-5 (PCL-5). Range: 0-80; higher scores indicate worse outcome.

  4. Change in posttraumatic stress symptoms at 3 months [ Time Frame: Baseline, 3 month follow-up ]
    Sum scores on PTSD Checklist-5 (PCL-5). Range: 0-80; higher scores indicate worse outcome.


Secondary Outcome Measures :
  1. Anxiety [ Time Frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up ]
    Sum scores on GAD-7. 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). 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 PHQ-8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants who self-identify as female are eligible to participate.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703258


Contacts
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Contact: Emily Dworkin, PhD 206-221-6932 edworkin@uw.edu
Contact: Christine Lee, PhD 206-543-6574 leecm@uw.edu

Locations
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United States, Washington
University of Washington School of Medicine Recruiting
Seattle, Washington, United States, 98105
Contact: Emily R Dworkin, PhD    206-221-6932    edworkin@uw.edu   
Sponsors and Collaborators
University of Washington
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Emily Dworkin, PhD University of Washington
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Responsible Party: Emily Dworkin, Acting Assistant Professor, School of Medicine: Psychiatry, University of Washington
ClinicalTrials.gov Identifier: NCT03703258    
Other Study ID Numbers: STUDY00005025
R00AA026317 ( U.S. NIH Grant/Contract )
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders