Testing the Impact of Thrive App Versions on Alcohol Use and Posttraumatic Stress After Recent Sexual Assault

Официальное название

Project THRIVE: Testing an App-based Early Intervention to Reduce Alcohol Use and PTSD After Sexual Assault

Обзор

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.

Вмешательства

• Поведенческое 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 w
• Поведенческое 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.
• Поведенческое 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 w
• Поведенческое 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 referr

Первичные конечные точки

• Past-month alcohol problems [Срок оценки: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year]
• Past-month number of drinks [Срок оценки: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year]
• Past-month number of drinking days [Срок оценки: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year]
• Past-month peak drinks [Срок оценки: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year]
• Past-month frequency of heavy episodic drinking [Срок оценки: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year]
• Past-month posttraumatic stress symptom severity [Срок оценки: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year]
• Past-month provisional diagnosis of posttraumatic stress disorder [Срок оценки: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year]

Вторичные конечные точки (4)

• Drug use & problems [Срок оценки: Baseline, 3 months, 6 months, 9 months, 1 year]
• Cannabis use & problems [Срок оценки: Baseline, 3 months, 6 months, 9 months, 1 year]
• Depression [Срок оценки: Baseline, 3 months, 6 months, 9 months, 1 year]
• Anxiety [Срок оценки: Baseline, 3 months, 6 months, 9 months, 1 year]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• Active psychosis
• Location outside of the US at the time of screening

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Washington — Seattle

Идентификаторы

NCT: NCT06444295 · STUDY00016193 · R01AA030541

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗