Mobile App Therapy for PTSD and Depression

Overseen By Haijing W Hallenbeck, PhD MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Mania, Psychosis, Suicidal ideation, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app designed to help Veterans with PTSD (posttraumatic stress disorder) and depression. The app, called Self-Guided STAIR Coach with Real-Time Assessment, is based on a type of talk therapy that teaches skills for handling emotions and relationships, aiming to improve daily life. Participants will use the app to track their mental health and observe how these skills help over time. Veterans who have both PTSD and major depression, are enrolled in VA care, and own a smartphone could be a good fit for this trial. As an unphased trial, this study offers Veterans the chance to explore innovative self-help tools that could enhance their mental health management.

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 mainly focuses on using a mobile app for therapy.

What prior data suggests that this mobile app therapy is safe for Veterans with PTSD and depression?

Research shows that the Self-Guided STAIR Coach app is based on a therapy that helps manage emotions and improve relationships. Studies have found that this therapy, when conducted in person, significantly reduces symptoms of PTSD and depression. Since the app employs this therapy, it is expected to be safe and user-friendly.

No specific negative effects have been reported for the app. Given the therapy's strong safety record in other forms, the app is likely safe to use. If any concerns or side effects arise, users can stop using the app at any time. Consulting a healthcare professional before joining such trials is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mobile App Therapy for PTSD and Depression because it offers a unique, tech-driven approach to mental health care. Unlike traditional treatments like cognitive behavioral therapy (CBT) or medication, this method uses the Self-Guided STAIR Coach app, which allows users to engage with therapeutic content at their own pace while receiving real-time assessments. This self-guided nature empowers individuals to access therapy whenever and wherever they need it, potentially increasing accessibility and adherence. Additionally, the real-time assessment feature can provide immediate feedback and support, making the treatment more interactive and personalized than standard options.

What evidence suggests that this trial's mobile app therapies could be effective for PTSD and depression?

Research has shown that the Self-Guided STAIR Coach app, which participants in this trial may receive, can greatly reduce symptoms of PTSD and depression. One study found that people using the app improved more in their PTSD symptoms than those who were waiting to start. Another study demonstrated significant improvements in both PTSD and depression, with a particular emphasis on PTSD. Face-to-face STAIR therapy has also proven effective in alleviating symptoms and enhancing social skills, and the app aims to offer similar benefits. These findings suggest that the app can effectively help Veterans manage PTSD and depression. Meanwhile, participants in another arm of this trial will receive the Real-Time Assessment app, which serves as an active comparator. ^{1 2 6 7 8}

Who Is on the Research Team?

Haijing Wu Hallenbeck, PhD MA

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Are You a Good Fit for This Trial?

This trial is for Veterans with PTSD and depression symptoms, aiming to improve their psychosocial functioning. Participants should be comfortable using a smartphone app designed to help manage emotions and relationships.

Exclusion Criteria

Current suicidal ideation with plan and intent to harm self

Acute intoxication from alcohol or other substances

Current or past experience with any form of STAIR

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the self-guided STAIR Coach app with real-time assessment for 12 weeks

12 weeks

Remote participation via mobile app

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Remote follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Real-Time Assessment
• Self-Guided STAIR Coach with Real-Time Assessment

Trial Overview The study tests a mobile app based on trauma-informed talk therapy, combined with real-time assessments through brief surveys and passive tracking on smartphones, to provide immediate feedback on mental health.

How Is the Trial Designed?

Group I: Self-Guided STAIR Coach with Real-Time Assessment Experimental Treatment 1 Intervention

Participants randomized to this condition will receive two mobile apps.

Group II: Real-Time Assessment Active Control 1 Intervention

Participants randomized to this condition will receive one mobile app.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

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 smartphone-based intervention program for military service members with subthreshold PTSD symptoms showed significant reductions in PTSD Checklist scores from baseline to post-intervention, with effects maintained at a 3-month follow-up.

The program, which included a Skype session and daily text messages guiding app use, was found to be feasible and acceptable to participants, indicating potential for broader application in addressing PTSD symptoms in military populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GETSmart: Guided Education and Training via Smart Phones to Promote Resilience. Roy, MJ., Highland, KB., Costanzo, MA.[2022]

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]

A pilot study involving 30 U.S. Veterans evaluated the Mindset mobile app, which uses heart rate monitoring to promote e-therapy, and found significant reductions in PTSD, anxiety, and depression symptoms after approximately one month of use.

Participants reported high satisfaction with the Mindset app, although they experienced frustration with the associated smartwatch, indicating that while mobile health tools can be effective, usability issues need to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving mental health in U.S. Veterans using mHealth tools: A pilot study. Latour, C., O'Byrne, L., McCarthy, M., et al.[2021]

Citations

1. withpower.com withpower.com/trial/mobile-app-therapy-for-ptsd-and-depression-1fad0

Mobile App Therapy for PTSD and Depression The Self-Guided STAIR Coach treatment is unique because it is a mobile app therapy that allows individuals to manage their PTSD and depression symptoms on their ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8128123/

improving symptoms and social functioning among female ... A recent randomized controlled trial study of STAIR delivered face-to-face in primary care indicated that the treatment provided significant reductions in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10527289/

Study protocol for a hybrid 1 effectiveness-implementation ... We hypothesize that: 1) Brief STAIR and webSTAIR will be effective in reducing PTSD symptoms (primary effectiveness aim) and mental health symptoms (secondary ...

4. academic.oup.com academic.oup.com/milmed/article/189/7-8/e1403/7619615

Preliminary Investigation Into the Effectiveness of Group ... Analyses revealed significant pre-to-post improvement in both PTSD and depression outcomes with a large effect size for PTSD (Hedges' gav = 0.88) ...

5. digitalcommons.georgiasouthern.edu digitalcommons.georgiasouthern.edu/cgi/viewcontent.cgi?article=3708&context=etd

The Use of an Evidenced Based Mobile App for PTSD Treatment When compared to wait list controls, participants in the STAIR Coach condition reported significantly greater reductions in PTSD symptoms and improvements in ...

6. ptsd.va.gov ptsd.va.gov/appvid/mobile/staircoach_app.asp

STAIR Coach - National Center for PTSD STAIR is an evidence-based cognitive behavioral form of psychotherapy designed to help with emotion regulation and interpersonal relationship problems.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06431022

Web-administered STAIR for Patients on Behavioral Health ... The aim of this randomized study is to implement webSTAIR at BMC in the Recovery from Stress and Trauma through Outpatient Care, Research, and Education ( ...

8. utppublishing.com utppublishing.com/doi/full/10.3138/jmvfh-2020-0002

Evaluating the quality of resilience apps for military members ... On the basis of the MARS guidelines, PTSD Coach scored 5 out of a possible 5 for demonstrating favorable outcomes in three or more RCTs. The remaining seven ...