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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03703258
Recruitment Status : Not yet recruiting
First Posted : October 11, 2018
Last Update Posted : December 12, 2019
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 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: Web-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 8 weeks. The intervention will be developed using user-centered design principles that attempt to maximize usability and satisfaction, and then preliminarily tested in a small open trial. In phase 1 (focus groups), a preliminary prototype intervention will be developed based on qualitative focus groups with N = 10 stakeholders (one-on-one interviews will be scheduled if necessary due to scheduling concerns) and a review of the existing clinical manuals from which the principles of the intervention are drawn. In phase 2 (usability testing), we will conduct iterative prototyping and usability testing with N = 10 survivors of SA to refine the intervention. This will involve in-person sessions in which participants complete intervention tasks while providing verbal feedback, with researcher monitoring of interactions with the website. Participants will also complete a usability survey and provide qualitative feedback. In phase 3 (open trial), after incorporating changes based on feedback, intervention feasibility will be tested in an open trial with N = 40 women with past-8-week SA histories, active drinking, and elevated distress. Participants will complete surveys at baseline, termination, and 6-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 6-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: Engaging Social Support to Prevent Problem Drinking and Posttraumatic Stress After Sexual Assault: Developing and Testing a Web-Based Intervention
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : September 1, 2023

Arm Intervention/treatment
Experimental: Intervention Behavioral: Web-based intervention
A web-based cognitive-behavioral intervention to prevent the development of PTSD and high-risk drinking in recently-victimized adults

No Intervention: Assessment-only control



Primary Outcome Measures :
  1. Change in problem drinking [ Time Frame: Baseline, change at post-intervention (3 weeks after baseline), change at 6 month follow-up ]
    Sum scores on Rutgers Alcohol Problem Index (RAPI). Range: 0-54; higher scores indicate worse outcome.

  2. Change in PTSD symptoms [ Time Frame: Baseline, change at post-intervention (3 weeks after baseline), change at 6 month follow-up ]
    Sum scores on PTSD Checklist-5 (PCL-5). Range: 0-80; higher scores indicate worse outcome.



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
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 8 weeks
  • age > 18
  • English fluency
  • telephone and internet access at least daily for 3 weeks and at least weekly for 6 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 206-221-2380 edworkin@uw.edu
Contact: Debra Kaysen, PhD 206-221-4657 dkaysen@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, Senior Fellow, School of Medicine: Psychiatry, University of Washington
ClinicalTrials.gov Identifier: NCT03703258    
Other Study ID Numbers: STUDY00005025
1K99AA026317-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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