Posttraumatic Stress SymptomNCT06444295
Testing the Impact of Thrive App Versions on Alcohol Use and Posttraumatic Stress After Recent Sexual Assault
A study testing Activity scheduling, Cognitive restructuring and Coaching calls in people with Posttraumatic Stress Symptom and Alcohol Drinking, run by University of Washington at 1 site in United States.
Trial summary
The goal of this study is to find the most effective and efficient version of the THRIVE app. The THRIVE app is the first app-based preventative intervention that has been found to reduce alcohol misuse and posttraumatic stress in people who have recently experienced sexual assault. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Symptom, Alcohol Drinking, Alcohol Problem
- What is being tested?
- Activity scheduling, Cognitive restructuring and Coaching calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 464 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2024to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have reached the legal age of majority in their current state of residence
- Be able to read and speak English fluently
- Own a smartphone that cannot be accessed by others while the study app is installed, or they agree to take steps to reduce the risk that someone else will access the study app
- Be an enrolled undergraduate or graduate student at a recruitment site at the time of screening, or if they are on summer break, plan to be enrolled in the upcoming fall term
- Reside in the same state as the recruitment site for most of the year
- Have experienced a sexual assault (i.e., unwanted and non-consensual attempted/completed sexual contact) within the past 12 weeks at the time of screening
- Report ≥1 past-month heavy drinking episode (i.e., 5+ drinks on a given day or 15+ drinks in a given week for participants assigned male at birth and 4+ drinks on a given day or 8+ drinks in a given week for participants assigned female or intersex at birth) at the time of screening
- Endorse elevated posttraumatic stress symptoms at screening (defined as a score above a pre-established cut point on a screening measure of PTSD).
Who cannot join
- Active psychosis
- Location outside of the US at the time of screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Project THRIVE: Testing an App-based Early Intervention to Reduce Alcohol Use and PTSD After Sexual Assault
The goal of this study is to find the most effective and efficient version of the THRIVE app. The THRIVE app is the first app-based preventative intervention that has been found to reduce alcohol misuse and posttraumatic stress in people who have recently experienced sexual assault. In this trial, participants are randomly assigned to receive different versions of the THRIVE app to compare their impact. The THRIVE app is currently only available to participants in this study.
- Being tested
- Activity scheduling, Cognitive restructuring, Coaching calls, Non-core intervention components
- Keywords
- Sexual assault, Mobile health intervention
- Medical subject headings
- Alcohol Drinking, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity schedulingBehavioural
Participants will engage in activity scheduling in the app (i.e., "Activities" module). On the first day of using the app, users will create a list of valued/important and avoided activities (e.g., spending time with friends, going to the gym), and then have the option to add alcohol protective behavioral strategies (e.g., adding ice to drinks, alternating alcoholic and nonalcoholic beverages) to activities that the user identifies as being likely to involve drinking. On subsequent days, users will be encouraged to complete at least one activity from their list.
Cognitive restructuringBehavioural
Participants will engage in cognitive restructuring in the app (i.e., "Thoughts" activities). Users first go through an activity involving the identification of maladaptive cognitions and create a list of their maladaptive cognitions. On subsequent days, they engage in a guided in-app activity involving cognitive restructuring of maladaptive cognitions from their list.
Coaching callsBehavioural
Participants will receive 10-20 minute weekly coaching calls during the app use period (4 total, including coaching provided in the enrollment call). All coaching calls will, at minimum, include a check-in, troubleshooting of technical issues, check-in about experience with symptom self-monitoring, and offers of referrals. Coaching calls in conditions involving activity scheduling will involve assistance with the Activities module. Coaching calls in conditions involving cognitive restructuring will involve assistance with the Thoughts module.
Non-core intervention componentsBehavioural
All participants, regardless of condition, will receive the following non-core THRIVE components.
- 21 days of brief self-report surveys in the app assessing their PTSD symptoms and alcohol use in the prior 24 hours.
- A banner in their app displaying rotating non-personalized encouraging messages from other users. All app users will have the option of submitting encouraging statements to be displayed to all other users. Statements will be vetted by study staff before posting.
- Lists of referral options specific to each recruitment site via the "Resources" section of the app.
- Answers to frequently asked questions about the study, the study consent form, and contact information for the study team via the "Information" section of the app.
- One call with a study "point person" within the first week following randomization to ensure they were able to access the app and troubleshoot access issues
| Study group | Role | What they receive |
|---|---|---|
| No experimental components | Active comparator | Participants are invited to use a version of the app for 21 days. Participants receive only the non-core intervention components and do not attend coaching calls. Receives: Behavioral: Non-core intervention components |
| Activities + Thoughts | Experimental | Participants are invited to use a version of the app for 21 days. Participants receive the Activities and Thoughts app modules, but do not attend coaching calls. Receives: Behavioral: Activity scheduling; Behavioral: Cognitive restructuring; Behavioral: Non-core intervention components |
| Activities only | Experimental | Participants are invited to use a version of the app for 21 days. Participants receive the Activities app module, but do not attend coaching calls. Receives: Behavioral: Activity scheduling; Behavioral: Non-core intervention components |
| Thoughts only | Experimental | Participants are invited to use a version of the app for 21 days. Participants receive the Thoughts app module, but do not attend coaching calls. Receives: Behavioral: Cognitive restructuring; Behavioral: Non-core intervention components |
| Activities, Thoughts, & Coaching | Experimental | Participants are invited to use a version of the app for 21 days. Participants receive the Activities and Thoughts app modules and attend coaching calls. Receives: Behavioral: Activity scheduling; Behavioral: Cognitive restructuring; Behavioral: Coaching calls; Behavioral: Non-core intervention components |
| Activities + Coaching | Experimental | Participants are invited to use a version of the app for 21 days. Participants receive the Activities app module and attend coaching calls. Receives: Behavioral: Activity scheduling; Behavioral: Coaching calls; Behavioral: Non-core intervention components |
| Thoughts + Coaching | Experimental | Participants are invited to use a version of the app for 21 days. Participants receive the Thoughts app module and attend coaching calls. Receives: Behavioral: Cognitive restructuring; Behavioral: Coaching calls; Behavioral: Non-core intervention components |
| Coaching only | Experimental | Participants are invited to use a version of the app for 21 days. Participants receive the non-core intervention components in the app and attend coaching calls. Receives: Behavioral: Coaching calls; Behavioral: Non-core intervention components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Past-month alcohol problems
Assessed using the 16-item Short Form Rutgers Alcohol Problem Index (S-RAPI). Minimum score = 0, maximum score = 64, higher scores mean greater severity of problems.
Measured: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Past-month number of drinks
Assessed via the online Timeline Followback (TLFB)
Measured: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Past-month number of drinking days
Assessed via the online Timeline Followback (TLFB)
Measured: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Past-month peak drinks
Assessed via the online Timeline Followback (TLFB)
Measured: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Past-month frequency of heavy episodic drinking
Assessed via the online Timeline Followback (TLFB)
Measured: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Past-month posttraumatic stress symptom severity
Assessed using the PTSD Checklist (PCL-5) in relation to the index assault. Minimum score = 0, maximum score = 80, higher scores mean greater severity of posttraumatic stress.
Measured: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Past-month provisional diagnosis of posttraumatic stress disorder
Assessed using the PTSD Checklist (PCL-5) in relation to the index assault. Provisional posttraumatic stress disorder diagnosis is defined as a score greater than or equal to 31.
Measured: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Secondary outcomes (4)
Drug use & problems
Assessed using the The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool Part 2 (not including alcohol questions)
Measured: Baseline, 3 months, 6 months, 9 months, 1 year
Cannabis use & problems
Assessed using the Cannabis Use Disorder Identification Test - Revised (CUDIT-R). Minimum score = 0, maximum score = 32, higher scores indicate hazardous cannabis use/possible cannabis use disorder.
Measured: Baseline, 3 months, 6 months, 9 months, 1 year
Depression
Assessed using the Center for Epidemiologic Studies Depression Scale - 10 item version. Minimum score = 0, maximum score = 30, higher scores mean greater depressive mood symptoms
Measured: Baseline, 3 months, 6 months, 9 months, 1 year
Anxiety
Assessed using the Generalized Anxiety Disorder-7 scale. Minimum score = 0, maximum score = 21, higher scores indicate greater severity of generalized anxiety symptoms.
Measured: Baseline, 3 months, 6 months, 9 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start29 Jul 2024
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress SymptomStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 464 participants (estimated)
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, Anna Jaffe, University of Washington
- Investigators
- Emily Dworkin, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444295
- Sponsor's protocol ID
- STUDY00016193
- Other IDs
- R01AA030541
- Status last verified
- Aug 2026
- First submitted
- 30 May 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project THRIVE: Testing an App-based Early Intervention to Reduce Alcohol Use and PTSD After Sexual Assault
- ClinicalTrials.gov ID
- NCT06444295
- Acronym / sponsor ID
- STUDY00016193
- Keywords
- Sexual assault, Mobile health intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 464 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to find the most effective and efficient version of the THRIVE app. The THRIVE app is the first app-based preventative intervention that has been found to reduce alcohol misuse and posttraumatic stress in people who have recently experienced sexual assault. In this trial, participants are randomly assigned to receive different versions of the THRIVE app to compare their impact. The THRIVE app is currently only available to participants in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| No experimental components | Active comparator | Behavioral: Non-core intervention componentsParticipants are invited to use a version of the app for 21 days. Participants receive only the non-core intervention components and do not attend coaching calls. |
| Activities + Thoughts | Experimental | Behavioral: Activity scheduling, Behavioral: Cognitive restructuring, Behavioral: Non-core intervention componentsParticipants are invited to use a version of the app for 21 days. Participants receive the Activities and Thoughts app modules, but do not attend coaching calls. |
| Activities only | Experimental | Behavioral: Activity scheduling, Behavioral: Non-core intervention componentsParticipants are invited to use a version of the app for 21 days. Participants receive the Activities app module, but do not attend coaching calls. |
| Thoughts only | Experimental | Behavioral: Cognitive restructuring, Behavioral: Non-core intervention componentsParticipants are invited to use a version of the app for 21 days. Participants receive the Thoughts app module, but do not attend coaching calls. |
| Activities, Thoughts, & Coaching | Experimental | Behavioral: Activity scheduling, Behavioral: Cognitive restructuring, Behavioral: Coaching calls, Behavioral: Non-core intervention componentsParticipants are invited to use a version of the app for 21 days. Participants receive the Activities and Thoughts app modules and attend coaching calls. |
| Activities + Coaching | Experimental | Behavioral: Activity scheduling, Behavioral: Coaching calls, Behavioral: Non-core intervention componentsParticipants are invited to use a version of the app for 21 days. Participants receive the Activities app module and attend coaching calls. |
| Thoughts + Coaching | Experimental | Behavioral: Cognitive restructuring, Behavioral: Coaching calls, Behavioral: Non-core intervention componentsParticipants are invited to use a version of the app for 21 days. Participants receive the Thoughts app module and attend coaching calls. |
| Coaching only | Experimental | Behavioral: Coaching calls, Behavioral: Non-core intervention componentsParticipants are invited to use a version of the app for 21 days. Participants receive the non-core intervention components in the app and attend coaching calls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have reached the legal age of majority in their current state of residence
- Be able to read and speak English fluently
- Own a smartphone that cannot be accessed by others while the study app is installed, or they agree to take steps to reduce the risk that someone else will access the study app
- Be an enrolled undergraduate or graduate student at a recruitment site at the time of screening, or if they are on summer break, plan to be enrolled in the upcoming fall term
- Reside in the same state as the recruitment site for most of the year
Key exclusion criteria (2 listed)
- Active psychosis
- Location outside of the US at the time of screening
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 |
|---|---|---|
| Activity schedulingParticipants will engage in activity scheduling in the app (i.e., "Activities" module). On the first day of using the app, users will create a list of valued/important and avoided activities (e.g., spending time with friends, going to the gym), and then have the option to add alcohol protective behavioral strategies (e.g., adding ice to drinks, alternating alcoholic and nonalcoholic beverages) to activities that the user identifies as being likely to involve drinking. On subsequent days, users will be encouraged to complete at least one activity from their list. | Behavioural | Activities + Coaching, Activities + Thoughts, Activities only, Activities, Thoughts, & Coaching |
| Cognitive restructuringParticipants will engage in cognitive restructuring in the app (i.e., "Thoughts" activities). Users first go through an activity involving the identification of maladaptive cognitions and create a list of their maladaptive cognitions. On subsequent days, they engage in a guided in-app activity involving cognitive restructuring of maladaptive cognitions from their list. | Behavioural | Activities + Thoughts, Activities, Thoughts, & Coaching, Thoughts + Coaching, Thoughts only |
| Coaching callsParticipants will receive 10-20 minute weekly coaching calls during the app use period (4 total, including coaching provided in the enrollment call). All coaching calls will, at minimum, include a check-in, troubleshooting of technical issues, check-in about experience with symptom self-monitoring, and offers of referrals. Coaching calls in conditions involving activity scheduling will involve assistance with the Activities module. Coaching calls in conditions involving cognitive restructuring will involve assistance with the Thoughts module. | Behavioural | Activities + Coaching, Activities, Thoughts, & Coaching, Coaching only, Thoughts + Coaching |
| Non-core intervention componentsAll participants, regardless of condition, will receive the following non-core THRIVE components. * 21 days of brief self-report surveys in the app assessing their PTSD symptoms and alcohol use in the prior 24 hours. * A banner in their app displaying rotating non-personalized encouraging messages from other users. All app users will have the option of submitting encouraging statements to be displayed to all other users. Statements will be vetted by study staff before posting. * Lists of referral options specific to each recruitment site via the "Resources" section of the app. * Answers to frequently asked questions about the study, the study consent form, and contact information for the study team via the "Information" section of the app. * One call with a study "point person" within the first week following randomization to ensure they were able to access the app and troubleshoot access issues | Behavioural | Activities + Coaching, Activities + Thoughts, Activities only, Activities, Thoughts, & Coaching, Coaching only, No experimental components, Thoughts + Coaching, Thoughts only |
Primary outcome
Past-month alcohol problems
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Assessed using the 16-item Short Form Rutgers Alcohol Problem Index (S-RAPI). Minimum score = 0, maximum score = 64, higher scores mean greater severity of problems.
Past-month number of drinks
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Assessed via the online Timeline Followback (TLFB)
Past-month number of drinking days
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Assessed via the online Timeline Followback (TLFB)
Past-month peak drinks
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Assessed via the online Timeline Followback (TLFB)
Past-month frequency of heavy episodic drinking
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Assessed via the online Timeline Followback (TLFB)
Past-month posttraumatic stress symptom severity
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Assessed using the PTSD Checklist (PCL-5) in relation to the index assault. Minimum score = 0, maximum score = 80, higher scores mean greater severity of posttraumatic stress.
Past-month provisional diagnosis of posttraumatic stress disorder
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Assessed using the PTSD Checklist (PCL-5) in relation to the index assault. Provisional posttraumatic stress disorder diagnosis is defined as a score greater than or equal to 31.
4 secondary outcomes
Drug use & problems
Time frame: Baseline, 3 months, 6 months, 9 months, 1 year
Cannabis use & problems
Time frame: Baseline, 3 months, 6 months, 9 months, 1 year
Depression
Time frame: Baseline, 3 months, 6 months, 9 months, 1 year
Anxiety
Time frame: Baseline, 3 months, 6 months, 9 months, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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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 Activity scheduling, Cognitive restructuring and Coaching calls in people with Posttraumatic Stress Symptom and Alcohol 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 8 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Past-month alcohol problems (time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.