Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Washington
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?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.
How is the THRIVE App treatment different from other treatments for PTSD and alcohol use?
The THRIVE App is unique because it offers an app-based intervention, which can extend the reach of early preventative care for PTSD and alcohol misuse, especially for those who may not access traditional treatments. This approach is novel as it leverages technology to provide support and intervention remotely, potentially increasing accessibility and engagement.
127911What data supports the effectiveness of the THRIVE App treatment for alcohol use and PTSD?
Research suggests that app-based interventions can help reduce the risk of chronic PTSD and alcohol misuse, especially when used early after traumatic events like sexual assault. Mobile mental health apps have been shown to support self-management of substance use disorders and related issues, indicating potential benefits for the THRIVE App in managing alcohol use and PTSD.
12689Is the THRIVE App safe for use in humans?
The available research on similar app-based interventions for PTSD and alcohol use suggests they are generally safe, but data protection and privacy standards are often poor. Most apps lack a strong evidence base, with only a few being scientifically evaluated in trials.
345910Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on using the THRIVE app, so you may not need to change your medication routine.
Eligibility Criteria
This trial is for adults who can read and speak English, are students at a recruitment site, have recently experienced sexual assault, show signs of posttraumatic stress, own a private smartphone, live in the same state as the recruitment site most of the year, and report recent heavy drinking.Participant Groups
The study tests different versions of the THRIVE app to see which one best reduces alcohol misuse and posttraumatic stress after sexual assault. Participants will be randomly assigned to use various features like activity scheduling or cognitive restructuring.
8Treatment groups
Experimental Treatment
Active Control
Group I: Thoughts onlyExperimental Treatment2 Interventions
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.
Group II: Thoughts + CoachingExperimental Treatment3 Interventions
Participants are invited to use a version of the app for 21 days. Participants receive the Thoughts app module and attend coaching calls.
Group III: Coaching onlyExperimental Treatment2 Interventions
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.
Group IV: Activities, Thoughts, & CoachingExperimental Treatment4 Interventions
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.
Group V: Activities onlyExperimental Treatment2 Interventions
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.
Group VI: Activities + ThoughtsExperimental Treatment3 Interventions
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.
Group VII: Activities + CoachingExperimental Treatment3 Interventions
Participants are invited to use a version of the app for 21 days. Participants receive the Activities app module and attend coaching calls.
Group VIII: No experimental componentsActive Control1 Intervention
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.
THRIVE App is already approved in United States for the following indications:
🇺🇸 Approved in United States as THRIVE App for:
- Alcohol Use Disorder
- Posttraumatic Stress Disorder (PTSD)
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of WashingtonSeattle, WA
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Who is running the clinical trial?
University of WashingtonLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
References
Posttraumatic stress disorder and alcohol dependence: does order of onset make a difference? [2018]Posttraumatic stress disorder (PTSD) and alcohol dependence (AD) are frequently comorbid and the order in which they develop may affect the clinical presentation and response to treatment. This study compared 73 treatment-seeking participants who developed PTSD prior to developing AD ("PTSD-first") with 64 participants who developed AD prior to developing PTSD ("AD-first") on demographics, clinical presentation, and response to treatment for PTSD and AD. All participants received BRENDA, a medication management and motivational enhancement intervention and were randomly assigned to either prolonged exposure (PE) for PTSD plus BRENDA or BRENDA alone and to either naltrexone (NAL) for AD or placebo (PBO). Results showed that participants with AD-first were more likely to report low income, meet criteria for antisocial or borderline personality disorder, report an index trauma of physical assault, compared to those with PTSD-first. Conversely, participants with PTSD-first were more likely to report an index trauma of sexual assault or a combat experience. Notably, no group differences were observed in treatment outcome despite some differences in clinical presentation.
Treatment Engagement: Female Survivors of Intimate Partner Violence in Treatment for PTSD and Alcohol Use Disorder. [2018]Treatment engagement rates are low for individuals with comorbid posttraumatic stress disorder (PTSD) and alcohol use disorders across available interventions and treatment modalities. A better understanding of who does and does not engage in treatment can help improve retention, completion, and subsequent treatment outcomes.
Feasibility, acceptability, and potential efficacy of the PTSD Coach app: A pilot randomized controlled trial with community trauma survivors. [2022]Posttraumatic stress disorder (PTSD) is a major public health concern. Although effective treatments exist, affected individuals face many barriers to receiving traditional care. Smartphones are carried by nearly 2 thirds of the U.S. population, offering a promising new option to overcome many of these barriers by delivering self-help interventions through applications (apps). As there is limited research on apps for trauma survivors with PTSD symptoms, we conducted a pilot feasibility, acceptability, and potential efficacy trial of PTSD Coach, a self-management smartphone app for PTSD.
'Help for trauma from the app stores?' A systematic review and standardised rating of apps for Post-Traumatic Stress Disorder (PTSD). [2021]Background: Mobile health applications (apps) are considered to complement traditional psychological treatments for Post-Traumatic Stress Disorder (PTSD). However, the use for clinical practice and quality of available apps is unknown. Objective: To assess the general characteristics, therapeutic background, content, and quality of apps for PTSD and to examine their concordance with established PTSD treatment and self-help methods. Method: A web crawler systematically searched for apps targeting PTSD in the British Google Play and Apple iTunes stores. Two independent researchers rated the apps using the Mobile App Rating Scale (MARS). The content of high-quality apps was checked for concordance with psychological treatment and self-help methods extracted from current literature on PTSD treatment. Results: Out of 555 identified apps, 69 met the inclusion criteria. The overall app quality based on the MARS was medium (M = 3.36, SD = 0.65). Most apps (50.7%) were based on cognitive behavioural therapy and offered a wide range of content, including established psychological PTSD treatment methods such as processing of trauma-related emotions and beliefs, relaxation exercises, and psychoeducation. Notably, data protection and privacy standards were poor in most apps and only one app (1.4%) was scientifically evaluated in a randomized controlled trial. Conclusions: High-quality apps based on established psychological treatment techniques for PTSD are available in commercial app stores. However, users are confronted with great difficulties in identifying useful high-quality apps and most apps lack an evidence-base. Commercial distribution channels do not exploit the potential of apps to complement the psychological treatment of PTSD.
Effectiveness of a Theory-Based mHealth Intervention for High-Risk Drinking in College Students. [2021]Background: College students are among the most vulnerable groups to problems associated with high-risk drinking consequences such as illness, injury, sexual abuse, and death. Promising mobile health (mHealth) approaches, such as smartphone (SP) apps, can be used in interventions to address or prevent excessive drinking. Method: The aim of the investigation was to examine the efficacy of a theoretically based mHealth SP app for alcohol intervention in two independent samples (N = 379): Mandated participants (Study 1) and voluntary participants (Study 2). Study 1 included a controlled trial with Mandated participants randomized into either an in-person Brief Motivational Interviewing BMI (n = 70) or BMI + SP app intervention (n = 71). Study 2 included Voluntary participants who participated in either a Control group (n = 157) or the BMI + SP app intervention (n = 81). Participants in both studies completed baseline and 6-week assessments. Results: In Study 1, peak Blood Alcohol Concentration (BAC) of participants in the in-person BMI group had increased slightly at six weeks, while it had decreased for the app-based BMI + SP group. Study 2 participants using the BMI + SP app reported significant reductions in drinking and consequences; there were no changes in the (AO) Control group. Conclusions: The BMI + SP app was effective with both Mandated and Voluntary participants. Future testing with the BMI + SP app is needed to assess whether reach, adoptability, portability, and sustainability are greater with the mHealth smartphone app for alcohol intervention than in-person approaches.
Differential alcohol treatment response by gender following use of VetChange. [2021]Proportionally more women use online alcohol interventions but also report less robust treatment outcomes compared to men. Less is known about outcome disparities among veteran women, who are a growing demographic nationally. The current study examined gender differences among returning veteran men and women who used VetChange, a web-based intervention for hazardous drinking and posttraumatic stress symptoms (PTSS).
Within-treatment clinical markers of dropout risk in integrated treatments for comorbid PTSD and alcohol use disorder. [2023]Integrated interventions for comorbid posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) are effective, but many patients prematurely drop out from treatment. Little is known about within-treatment risk factors for dropout, limiting the ability during therapy to identify patients at risk for attrition.
Mobile Mental Health Apps from the National Center for PTSD: Digital Self-Management Tools for Co-Occurring Disorders. [2021]Mobile mental health apps can help bridge gaps in access to care for those with substance use disorders and dual diagnoses. The authors describe a portfolio of free, publicly available mobile mental health apps developed by the National Center for PTSD. The authors also demonstrate how this suite of primarily non-substance use disorder-specific mobile mental health apps may support the active ingredients of substance use disorder treatment or be used for self-management of substance use disorder and related issues. The potential advantages of these apps, as well as limitations and considerations for future app development, are discussed.
Pilot randomized clinical trial of an app-based early intervention to reduce PTSD and alcohol use following sexual assault. [2023]Sexual assault is associated with high risk for posttraumatic stress disorder (PTSD), and PTSD often co-occurs with alcohol misuse. Most sexual assault survivors do not access early preventative interventions for such conditions. App-based interventions are a promising means to extend the reach of early interventions and thereby reduce risk of chronic PTSD and alcohol misuse.
Design, development and pilot testing of 'Quest', a smartphone-based relapse prevention app for patients with alcohol dependence. [2023]To design, develop and pilot the 'Quest' app for smartphone-based relapse prevention for patients diagnosed with alcohol dependence syndrome (ADS).
A Seeking Safety Mobile App for Recovery from PTSD and Substance Use Disorder: Results of a Randomized Controlled Trial. [2023]Posttraumatic stress disorder (PTSD) and substance use disorder (SUD) co-occur frequently and have deleterious impact. Seeking Safety (SS) - an evidence-based, present-focused, coping skills model - lends itself to mobile app delivery.