Project THRIVE: Testing an App-based Early Intervention to Reduce Alcohol Use and PTSD After Sexual Assault
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 464
- 试验地点
- 1
- 主要终点
- Past-month number of drinks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Active psychosis
- •Location outside of the US at the time of screening
研究组 & 干预措施
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.
干预措施: Non-core intervention components (Behavioral)
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.
干预措施: Activity scheduling (Behavioral)
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.
干预措施: Cognitive restructuring (Behavioral)
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.
干预措施: Non-core intervention components (Behavioral)
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.
干预措施: Activity scheduling (Behavioral)
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.
干预措施: Non-core intervention components (Behavioral)
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.
干预措施: Non-core intervention components (Behavioral)
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.
干预措施: Cognitive restructuring (Behavioral)
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.
干预措施: Activity scheduling (Behavioral)
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.
干预措施: Cognitive restructuring (Behavioral)
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.
干预措施: Coaching calls (Behavioral)
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.
干预措施: Non-core intervention components (Behavioral)
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.
干预措施: Non-core intervention components (Behavioral)
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.
干预措施: Activity scheduling (Behavioral)
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.
干预措施: Coaching calls (Behavioral)
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.
干预措施: Non-core intervention components (Behavioral)
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.
干预措施: Coaching calls (Behavioral)
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.
干预措施: Non-core intervention components (Behavioral)
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.
干预措施: Cognitive restructuring (Behavioral)
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.
干预措施: Coaching calls (Behavioral)
结局指标
主要结局
Past-month number of drinks
时间窗: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Assessed via the online Timeline Followback (TLFB)
Past-month number of drinking days
时间窗: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Assessed via the online Timeline Followback (TLFB)
Past-month peak drinks
时间窗: 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
时间窗: Baseline, 1 month, 3 months, 6 months, 9 months, 1 year
Assessed via the online Timeline Followback (TLFB)
Past-month provisional diagnosis of posttraumatic stress disorder
时间窗: 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.
Past-month alcohol problems
时间窗: 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 posttraumatic stress symptom severity
时间窗: 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.
次要结局
- Cannabis use & problems(Baseline, 3 months, 6 months, 9 months, 1 year)
- Drug use & problems(Baseline, 3 months, 6 months, 9 months, 1 year)
- Anxiety(Baseline, 3 months, 6 months, 9 months, 1 year)
- Depression(Baseline, 3 months, 6 months, 9 months, 1 year)
研究者
Anna Jaffe
Associate Professor
University of Washington