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

Primary Purpose

Post Traumatic Stress Disorder, Problem Drinking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
App-based intervention
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Assessment-only control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Anxiety
Sum scores on Generalized Anxiety Disorder-7 (GAD-7), which assesses symptoms of anxiety. Range: 0-21; higher scores indicate worse outcome.
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.
Depression
Sum scores on the Patient Health Questionnaire-8 (PHQ-8), which assesses symptoms of depression. Range: 0-24; higher scores indicate worse outcome.
Alcohol Consumption (Quantity)
Number of drinks per week reported on the Daily Drinking Questionnaire
Alcohol Consumption (Frequency)
Number of drinking days per week reported on the Daily Drinking Questionnaire
Alcohol Consumption (Hours)
Hours spent drinking per week reported on the Daily Drinking Questionnaire

Full Information

First Posted
June 11, 2018
Last Updated
November 15, 2022
Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03703258
Brief Title
Tools for Health and Resilience Implemented After Violence Exposure (Project THRIVE)
Official Title
Preventing Risky Drinking and PTSD After Sexual Assault: A Web-Based Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
August 24, 2021 (Actual)
Study Completion Date
November 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Problem Drinking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Assessment-only control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
App-based intervention
Other Intervention Name(s)
THRIVE app
Intervention Description
A app-based cognitive-behavioral intervention to prevent the development of PTSD and high-risk drinking in recently-victimized adults
Primary Outcome Measure Information:
Title
Problem Drinking Scores at Baseline and 3 Weeks
Description
Sum scores on Rutgers Alcohol Problem Index- Short Form (RAPI-S), which assesses alcohol use consequences. Range: 0-64; higher scores indicate worse outcome.
Time Frame
Baseline, post-intervention (3 weeks after baseline)
Title
Problem Drinking Scores at Baseline and 3 Months
Description
Sum scores on Rutgers Alcohol Problem Index- Short Form (RAPI-S), which assesses alcohol use consequences. Range: 0-64; higher scores indicate worse outcome.
Time Frame
Baseline, 3 month follow-up
Title
Posttraumatic Stress Symptom Severity Score at Baseline and 3 Weeks
Description
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.
Time Frame
Baseline, post-intervention (3 weeks after baseline)
Title
Posttraumatic Stress Symptom Severity Score at Baseline and 3 Months
Description
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.
Time Frame
Baseline, 3 month follow-up
Secondary Outcome Measure Information:
Title
Anxiety
Description
Sum scores on Generalized Anxiety Disorder-7 (GAD-7), which assesses symptoms of anxiety. Range: 0-21; higher scores indicate worse outcome.
Time Frame
Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Title
Coping Self-efficacy
Description
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.
Time Frame
Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Title
Depression
Description
Sum scores on the Patient Health Questionnaire-8 (PHQ-8), which assesses symptoms of depression. Range: 0-24; higher scores indicate worse outcome.
Time Frame
Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Title
Alcohol Consumption (Quantity)
Description
Number of drinks per week reported on the Daily Drinking Questionnaire
Time Frame
Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Title
Alcohol Consumption (Frequency)
Description
Number of drinking days per week reported on the Daily Drinking Questionnaire
Time Frame
Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Title
Alcohol Consumption (Hours)
Description
Hours spent drinking per week reported on the Daily Drinking Questionnaire
Time Frame
Baseline, post-intervention (3 weeks after baseline), 3 month follow-up

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants who self-identify as female are eligible to participate.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Dworkin, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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