THRIVE App for Alcohol Use and PTSD

Overseen By Emily Dworkin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Active psychosis, Location outside US

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

464 Participants Needed

Trial Summary

Will 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.

What 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. ^{1 2 3 4 5}

Is 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. ^{1 6 7 8 9}

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. ^{1 4 5 10 11}

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.

Research Team

Emily Dworkin, PhD

Principal Investigator

University of Washington

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.

Inclusion Criteria

Have experienced a sexual assault within the past 12 weeks at the time of screening

Reside in the same state as the recruitment site for most of the year

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

Exclusion Criteria

Active psychosis

Location outside of the US at the time of screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to receive different versions of the THRIVE app for 21 days to compare their impact on alcohol misuse and posttraumatic stress.

3 weeks

App-based intervention, no in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment using various assessments including alcohol use, PTSD symptoms, and mental health measures.

12 months

Assessments at 1 month, 3 months, 6 months, 9 months, and 1 year

Treatment Details

Interventions

• THRIVE App

Trial Overview 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.

Participant Groups

Group I: Thoughts only Experimental Treatment 2 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 + Coaching Experimental Treatment 3 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 only Experimental Treatment 2 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, & Coaching Experimental Treatment 4 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 only Experimental Treatment 2 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 + Thoughts Experimental Treatment 3 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 + Coaching Experimental Treatment 3 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 components Active Control 1 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)

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

The THRIVE app, combined with phone coaching, significantly reduced symptoms of posttraumatic stress disorder (PTSD) and alcohol misuse among 41 female survivors of recent sexual assault over a 3-month follow-up period.

Participants using the THRIVE app showed greater improvements in PTSD and alcohol-related issues compared to those using a symptom-monitoring app, suggesting that app-based interventions can effectively support early recovery for sexual assault survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized clinical trial of an app-based early intervention to reduce PTSD and alcohol use following sexual assault. Dworkin, ER., Schallert, M., Lee, CM., et al.[2023]

Mobile mental health apps developed by the National Center for PTSD can improve access to care for individuals with substance use disorders and dual diagnoses, providing valuable support for treatment.

These apps, while not specifically designed for substance use disorders, can enhance self-management and treatment by incorporating key therapeutic elements, although there are limitations and considerations for future development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Mental Health Apps from the National Center for PTSD: Digital Self-Management Tools for Co-Occurring Disorders. McGee-Vincent, P., Juhasz, K., Jamison, AL., et al.[2021]

In a study of 222 returning combat veterans using the VetChange online intervention, both men and women showed significant decreases in alcohol use and posttraumatic stress symptoms (PTSS) over six months, but men had greater reductions in drinking compared to women.

Women veterans were less likely to achieve low-risk drinking levels by one month post-registration, indicating a need for tailored content changes in online interventions to better support their treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential alcohol treatment response by gender following use of VetChange. Livingston, NA., Simpson, T., Lehavot, K., et al.[2021]

In a study of 137 treatment-seeking participants, those with alcohol dependence (AD) first showed different demographic and clinical characteristics compared to those with PTSD first, such as lower income and higher rates of certain personality disorders.

Despite these differences in clinical presentation, both groups responded similarly to treatment involving BRENDA and either prolonged exposure therapy for PTSD or naltrexone for alcohol dependence, indicating that the order of onset may not significantly impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttraumatic stress disorder and alcohol dependence: does order of onset make a difference? McLean, CP., Su, YJ., Foa, EB.[2018]

In a study of 40 female survivors of intimate partner violence with PTSD and alcohol use disorder, older women and those with fewer dependents were more likely to engage in treatment, highlighting demographic factors that influence treatment retention.

Greater PTSD symptoms related to avoidance/numbing and longer histories of heavy drinking were also linked to higher treatment engagement, suggesting that specific symptom profiles may affect a person's likelihood to participate in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Engagement: Female Survivors of Intimate Partner Violence in Treatment for PTSD and Alcohol Use Disorder. Myers, US., Browne, KC., Norman, SB.[2018]

Out of 555 mobile health apps targeting PTSD, only 69 met the criteria for inclusion, with an overall quality rating of medium, indicating that while some apps are based on effective cognitive behavioral therapy techniques, many lack rigorous scientific evaluation.

Most apps do not meet adequate data protection and privacy standards, and only one app was scientifically evaluated in a randomized controlled trial, highlighting the need for better quality control and evidence-based practices in the development of PTSD apps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Help for trauma from the app stores?' A systematic review and standardised rating of apps for Post-Traumatic Stress Disorder (PTSD). Sander, LB., Schorndanner, J., Terhorst, Y., et al.[2021]

The study involving 379 college students showed that a smartphone app combined with Brief Motivational Interviewing (BMI) effectively reduced alcohol consumption and related consequences, particularly in voluntary participants.

In a controlled trial, participants using the app had a decrease in peak Blood Alcohol Concentration (BAC) compared to those receiving only in-person BMI, highlighting the app's potential as a beneficial tool for alcohol intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Theory-Based mHealth Intervention for High-Risk Drinking in College Students. Kazemi, DM., Borsari, B., Levine, MJ., et al.[2021]

The pilot study involving 49 trauma survivors indicated that the PTSD Coach app is feasible and acceptable, with participants using it frequently and reporting it as moderately helpful for managing their symptoms.

While the app showed modest effect sizes for PTSD symptom improvement, the results were not statistically significant, suggesting that more research is needed to fully evaluate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and potential efficacy of the PTSD Coach app: A pilot randomized controlled trial with community trauma survivors. Miner, A., Kuhn, E., Hoffman, JE., et al.[2022]

The 'Quest' app, designed for relapse prevention in patients with alcohol dependence syndrome, received high usability (5.8 out of 7) and acceptability (65%) ratings from users, indicating it is user-friendly and well-received.

While both groups (those using the Quest app and those receiving standard treatment) showed a significant reduction in drinking days over three months, there was no notable difference in relapse rates or heavy drinking days between the two groups, suggesting the app's effectiveness needs further validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design, development and pilot testing of 'Quest', a smartphone-based relapse prevention app for patients with alcohol dependence. Sharma, AK., Shadakshari, D., Chand, P., et al.[2023]

In a study of 110 veterans undergoing treatment for comorbid PTSD and alcohol use disorder, increased alcohol consumption during therapy was linked to a significantly higher risk of dropping out, particularly in those receiving integrated exposure therapy.

Specifically, for each additional drink consumed per day, the risk of dropout increased fivefold, highlighting the importance of monitoring alcohol use as a potential marker for patient retention in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Within-treatment clinical markers of dropout risk in integrated treatments for comorbid PTSD and alcohol use disorder. Kline, AC., Panza, KE., Harlé, KM., et al.[2023]

The Seeking Safety (SS) mobile app significantly reduced substance use and trauma symptoms in outpatients with PTSD and substance use disorder, outperforming a control app in a study involving 116 participants over 12 weeks.

This study is important as it demonstrates that mobile apps can effectively deliver mental health interventions, especially since many apps show limited positive outcomes in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Seeking Safety Mobile App for Recovery from PTSD and Substance Use Disorder: Results of a Randomized Controlled Trial. Najavits, LM., Cha, E., Demce, MG., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pilot randomized clinical trial of an app-based early intervention to reduce PTSD and alcohol use following sexual assault. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Mobile Mental Health Apps from the National Center for PTSD: Digital Self-Management Tools for Co-Occurring Disorders. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Differential alcohol treatment response by gender following use of VetChange. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Posttraumatic stress disorder and alcohol dependence: does order of onset make a difference? [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment Engagement: Female Survivors of Intimate Partner Violence in Treatment for PTSD and Alcohol Use Disorder. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

'Help for trauma from the app stores?' A systematic review and standardised rating of apps for Post-Traumatic Stress Disorder (PTSD). [2021]

7. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a Theory-Based mHealth Intervention for High-Risk Drinking in College Students. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and potential efficacy of the PTSD Coach app: A pilot randomized controlled trial with community trauma survivors. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Design, development and pilot testing of 'Quest', a smartphone-based relapse prevention app for patients with alcohol dependence. [2023]

10. Ireland pubmed.ncbi.nlm.nih.gov

Within-treatment clinical markers of dropout risk in integrated treatments for comorbid PTSD and alcohol use disorder. [2023]

11. England pubmed.ncbi.nlm.nih.gov

A Seeking Safety Mobile App for Recovery from PTSD and Substance Use Disorder: Results of a Randomized Controlled Trial. [2023]