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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Posttraumatic stress disorder (PTSD) and depression are the two most common mental health conditions among Veterans. When Veterans experience both, there is a negative impact on their functioning, making it difficult to function at work or at home and socially with other people. Although talk therapies can result in improvements in functioning, they are difficult to access because there are limited clinicians who can provide them. As most US adults now own a smartphone, mobile apps are a way for Veterans to access content traditionally delivered through talk therapies at their own pace. This study will test a mobile app based on a trauma-informed talk therapy that has helped Veterans with PTSD and depression make large improvements in functioning, through learning skills to navigate emotions and relationships. Additionally, through answering brief surveys and enabling passive tracking on their smartphones, Veterans will see real-time information on their functioning and mental health and on potential benefits from using these skills.

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 data supports the effectiveness of the treatment Real-Time Assessment, Self-Guided STAIR Coach with Real-Time Assessment for PTSD and Depression?

Research on similar mobile app interventions, like the PTSD Coach app, shows they can help reduce symptoms of PTSD and depression. Studies found that these apps are generally well-received and can lead to improvements in mental health over time, especially when used consistently. ^{1 2 3 4 5}

Is the mobile app therapy for PTSD and depression safe for humans?

Research on smartphone apps for PTSD, like PTSD Coach, shows they are generally safe and well-received by users. Some users reported minor negative effects, but overall, the apps were considered helpful and satisfactory. ^{2 3 4 6 7}

What makes the Self-Guided STAIR Coach treatment unique 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 own, anytime and anywhere, which can help reduce stigma and improve access to care. Unlike traditional therapies that require in-person sessions, this app provides real-time assessments and self-management tools, making it a flexible and accessible option for users. ^{1 2 3 6 8}

Research Team

Haijing Wu Hallenbeck, PhD MA

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. 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]

2. Netherlands pubmed.ncbi.nlm.nih.gov

GETSmart: Guided Education and Training via Smart Phones to Promote Resilience. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Longitudinal follow-up of the randomized controlled trial of access to the trauma-focused self-management app PTSD Coach. [2023]

4. 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]

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

A clinician-monitored 'PTSD Coach' intervention: findings from two pilot feasibility and acceptability studies in a resource-constrained setting. [2022]

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

An App a Day Keeps the Doctor Away: Guided Education and Training via Smartphones in Subthreshold Post Traumatic Stress Disorder. [2022]

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

A randomized controlled trial of a smartphone app for posttraumatic stress disorder symptoms. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Improving mental health in U.S. Veterans using mHealth tools: A pilot study. [2021]