Mobile App Intervention for PTSD and Alcoholism

Overseen By LeAnn Smart

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michigan State University

Disqualifiers: Injection drug use, Non-English speakers, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 months

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn whether a mobile health application (mHealth App) for posttraumatic stress disorder (PTSD) with brief support can help individuals who are in treatment for alcohol problems.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for PTSD and Alcoholism using the PTSD Coach App and other therapies?

Research shows that app-based interventions like the PTSD Coach App are feasible and generally well-received by users, although more studies are needed to confirm their effectiveness in reducing PTSD symptoms. Additionally, cognitive therapies adapted for PTSD and alcohol use have shown promise in improving symptoms and reducing alcohol-related problems. ^{1 2 3 4 5}

Is the mobile app intervention for PTSD and alcoholism safe for humans?

The 'PTSD Coach' mobile app has been found to be generally safe and well-received by users, with high satisfaction and perceived helpfulness reported in studies. However, more research is needed to confirm its effectiveness and safety across diverse populations. ^{1 2 3 6 7}

How is the Mobile App Intervention for PTSD and Alcoholism different from other treatments?

This treatment is unique because it uses a mobile app to provide early intervention for PTSD and alcohol misuse, making it more accessible to individuals who may not seek traditional therapy. It combines brief support therapy with the PTSD Coach App, which is designed to help manage symptoms and reduce the risk of chronic PTSD and alcohol misuse, especially following traumatic events like sexual assault. ^{1 2 5 8 9}

Research Team

Kipling Bohnert

Principal Investigator

Michigan State University

Eligibility Criteria

This trial is for people currently in addiction treatment, with a PTSD score of 33+ on the PCL-5, who own a smartphone or Wi-Fi-enabled device that can use apps. They must meet DSM-5 criteria for alcohol use disorder but cannot have used injection drugs in the past year or struggle with English.

Inclusion Criteria

Meet criteria for a current Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) AUD diagnosis

Own a smart phone or other type of Wi-Fi-enabled device with App capabilities

A score of 33 or greater on the PTSD Checklist (PCL-5)

Exclusion Criteria

Patients who are unable to speak and/or understand English

I am currently undergoing therapy for PTSD.

Injection drug use in the past year

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the PTSD Coach App with brief support to manage PTSD symptoms while receiving treatment for alcohol problems

12 months

Baseline, 1-, 3-, 6-, and 12-months assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Brief Support
• Enhanced Usual Care (EUC)
• PTSD Coach App

Trial Overview The study tests if an mHealth App called PTSD Coach, along with brief support, improves outcomes for those treating alcohol problems compared to Enhanced Usual Care (EUC), which does not include the app.

Participant Groups

Group I: PTSD Coach App + Brief Support Experimental Treatment 1 Intervention

PTSD Coach App + Brief Support will include brief instruction and support for the use of the PTSD Coach App developed by the study team. The PTSD Coach App incorporates evidence-based assessment, psychoeducation, and self-management strategies for PTSD symptoms that are customizable to the user.

Group II: Enhanced Usual Care (EUC) Active Control 1 Intervention

EUC will include brief psychoeducation regarding PTSD and alcohol use disorder (AUD) and resources for PTSD-related mental health treatment.

Brief Support is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Brief Support for:

• Alcohol Use Disorder
• Posttraumatic Stress Disorder (PTSD)

Approved in European Union as Brief Intervention for:

• Substance Abuse Disorders
• Alcohol Dependence
• PTSD

Approved in Canada as Brief Support Therapy for:

• Alcohol Use Disorder
• Mental Health Disorders including PTSD

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials

202

Recruited

687,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

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 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]

The 'PTSD Coach' intervention, available as both a web-based and mobile application, is feasible and generally well-accepted among trauma-exposed individuals, with high satisfaction reported in most studies.

However, the effectiveness of the 'PTSD Coach' in significantly reducing posttraumatic stress symptoms (PTSS) remains unclear, as the pooled effect size was not statistically significant, indicating a need for further research, especially in low-middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and effectiveness of web-based and mobile PTSD Coach: a systematic review and meta-analysis. Bröcker, E., Suliman, S., Olff, M., et al.[2023]

A 12-week course of modified Cognitive Processing Therapy (CPT-C) effectively improved PTSD symptoms and reduced alcohol dependence in a combat veteran, showing promise for treating co-occurring conditions.

The veteran maintained significant improvements in both PTSD and alcohol-related issues 12 weeks after completing the treatment, suggesting the long-term efficacy of this enhanced therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report on the use of cognitive processing therapy-cognitive, enhanced to address heavy alcohol use. McCarthy, E., Petrakis, I.[2022]

A new cognitive behavioral therapy (CBT) for PTSD was adapted for patients in community addiction treatment, showing promising results in a study involving 11 patients.

The therapy led to favorable outcomes in reducing PTSD severity, substance use, and improving patient retention, indicating it could be an effective treatment option for those with co-occurring PTSD and substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cognitive behavioral therapy for co-occurring substance use and posttraumatic stress disorders. McGovern, MP., Lambert-Harris, C., Acquilano, S., et al.[2022]

A brief alcohol intervention for 68 combat veterans significantly reduced PTSD symptom severity over 6 weeks and 6 months, indicating its potential effectiveness in addressing both alcohol misuse and PTSD.

The study found that changes in alcohol use were related to changes in PTSD severity, suggesting that targeting alcohol consumption can positively impact PTSD symptoms, even without the added motivational interview component.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttraumatic stress disorder symptoms improve after an integrated brief alcohol intervention for OEF/OIF/OND veterans. Luciano, MT., McDevitt-Murphy, ME., Acuff, SF., et al.[2020]

PTSD is prevalent among primary care patients and leads to significant functional and health issues, highlighting the need for effective treatment options within this setting.

Cognitive and behavioral therapies show the most promise as brief interventions for PTSD in primary care, but more research is needed to develop and validate these treatments specifically for this environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current state of intervention research for posttraumatic stress disorder within the primary care setting. Possemato, K.[2021]

Behavioral interventions for treating alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) include a variety of evidence-based approaches, such as relapse prevention and cognitive processing therapy, which can help improve outcomes for individuals with these conditions.

Integrated treatment models that address both AUD and PTSD simultaneously may be more effective than sequential treatments, highlighting the need for further research to tailor interventions based on individual characteristics like gender and treatment goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Treatments for Alcohol Use Disorder and Post-Traumatic Stress Disorder. Flanagan, JC., Jones, JL., Jarnecke, AM., et al.[2023]

The THRIVE mobile health intervention, designed for recent survivors of sexual assault, demonstrated feasibility with high engagement rates: 95% of participants completed at least one cognitive behavioral exercise, and 80% attended all coaching calls over a 21-day period.

Participants rated THRIVE highly in terms of usability and satisfaction, with 94% finding the app moderately to very helpful, indicating that it is an acceptable tool for addressing posttraumatic stress and alcohol misuse in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Early Intervention to Reduce Posttraumatic Stress and Alcohol Use After Sexual Assault (THRIVE): Feasibility and Acceptability Results From a Pilot Trial. Dworkin, ER., Schallert, M., Lee, CM., et al.[2023]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

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

2. 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]

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

Feasibility, acceptability, and effectiveness of web-based and mobile PTSD Coach: a systematic review and meta-analysis. [2023]

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

Case report on the use of cognitive processing therapy-cognitive, enhanced to address heavy alcohol use. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A cognitive behavioral therapy for co-occurring substance use and posttraumatic stress disorders. [2022]

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

Posttraumatic stress disorder symptoms improve after an integrated brief alcohol intervention for OEF/OIF/OND veterans. [2020]

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

The current state of intervention research for posttraumatic stress disorder within the primary care setting. [2021]

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

Behavioral Treatments for Alcohol Use Disorder and Post-Traumatic Stress Disorder. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

mHealth Early Intervention to Reduce Posttraumatic Stress and Alcohol Use After Sexual Assault (THRIVE): Feasibility and Acceptability Results From a Pilot Trial. [2023]