Post Traumatic Stress DisorderNCT03703258
Tools for Health and Resilience Implemented After Violence Exposure (Project THRIVE)
A study testing App-based intervention in people with Post Traumatic Stress Disorder and Problem Drinking, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Traumatic Stress Disorder, Problem Drinking
- What is being tested?
- App-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2021to 20 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- active suicidality
- psychosis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington School of Medicine
Seattle, Washington, 98105
About this study
Official title: Preventing Risky Drinking and PTSD After Sexual Assault: A Web-Based Intervention
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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder, Problem Drinking
- Being tested
- App-based intervention
- Medical subject headings
- Stress Disorders, Post-Traumatic, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based interventionBehavioural
Also called THRIVE app
A app-based cognitive-behavioral intervention to prevent the development of PTSD and high-risk drinking in recently-victimized adults
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 month follow-up
Secondary outcomes (6)
Anxiety
Sum scores on Generalized Anxiety Disorder-7 (GAD-7), which assesses symptoms of anxiety. Range: 0-21; higher scores indicate worse outcome.
Measured: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
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.
Measured: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Depression
Sum scores on the Patient Health Questionnaire-8 (PHQ-8), which assesses symptoms of depression. Range: 0-24; higher scores indicate worse outcome.
Measured: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Alcohol Consumption (Quantity)
Number of drinks per week reported on the Daily Drinking Questionnaire
Measured: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Alcohol Consumption (Frequency)
Number of drinking days per week reported on the Daily Drinking Questionnaire
Measured: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Alcohol Consumption (Hours)
Hours spent drinking per week reported on the Daily Drinking Questionnaire
Measured: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start13 Jan 2021
- Primary completion24 Aug 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Emily Dworkin, University of Washington
- Investigators
- Emily Dworkin, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703258
- Sponsor's protocol ID
- STUDY00005025
- Other IDs
- R00AA026317
- Status last verified
- Nov 2022
- First submitted
- 11 Jun 2018
- Last updated
- 2 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38376992O'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.
PubMed 37795783Dworkin 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.
PubMed 37402144Dworkin 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.
PubMed 37011153
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Risky Drinking and PTSD After Sexual Assault: A Web-Based Intervention
- ClinicalTrials.gov ID
- NCT03703258
- Acronym / sponsor ID
- STUDY00005025
- Conditions
- Post Traumatic Stress Disorder, Problem Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 11 Oct 2018 (actual)
- Results
- Posted 2 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: App-based interventionThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- active suicidality
- psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based interventionAlso: THRIVE appA app-based cognitive-behavioral intervention to prevent the development of PTSD and high-risk drinking in recently-victimized adults | Behavioural | Intervention |
Primary outcome
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.
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.
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.
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.
6 secondary outcomes
Anxiety
Time frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Coping Self-efficacy
Time frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Depression
Time frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Alcohol Consumption (Quantity)
Time frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Alcohol Consumption (Frequency)
Time frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Alcohol Consumption (Hours)
Time frame: Baseline, post-intervention (3 weeks after baseline), 3 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38376992Howe 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.
- Derived from this study: PubMed 37795783O'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.
- Derived from this study: PubMed 37402144Dworkin 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.
- Derived from this study: PubMed 37011153Dworkin 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.
- Individual participant dataSharing planned: No
Related trials for Post Traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Dworkin, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-based intervention in people with Post Traumatic Stress Disorder and Problem Drinking, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Problem Drinking Scores at Baseline and 3 Weeks (time frame: Baseline, post-intervention (3 weeks after baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03703258, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.