Testing the Impact of Thrive App Versions on Alcohol Use and Posttraumatic Stress After Recent Sexual Assault
NCT ID: NCT06444295
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
464 participants
INTERVENTIONAL
2024-07-29
2027-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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No experimental components
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.
Non-core intervention components
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
Activities + Thoughts
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.
Activity scheduling
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 restructuring
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.
Non-core intervention components
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
Activities only
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.
Activity scheduling
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.
Non-core intervention components
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
Thoughts only
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.
Cognitive restructuring
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.
Non-core intervention components
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
Activities, Thoughts, & Coaching
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.
Activity scheduling
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 restructuring
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 calls
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 components
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
Activities + Coaching
Participants are invited to use a version of the app for 21 days. Participants receive the Activities app module and attend coaching calls.
Activity scheduling
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.
Coaching calls
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 components
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
Thoughts + Coaching
Participants are invited to use a version of the app for 21 days. Participants receive the Thoughts app module and attend coaching calls.
Cognitive restructuring
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 calls
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 components
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
Coaching only
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.
Coaching calls
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 components
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
Interventions
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Activity scheduling
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 restructuring
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 calls
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 components
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
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* Location outside of the US at the time of screening
18 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
University of Washington
OTHER
Responsible Party
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Emily Dworkin
Associate Professor
Principal Investigators
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Emily Dworkin, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington
Seattle, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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STUDY00016193
Identifier Type: -
Identifier Source: org_study_id
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