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Self-Guided STAIR Coach with Real-Time Assessment for Post-Traumatic Stress Disorder

N/A
Waitlist Available
Led By Haijing Wu Hallenbeck, PhD MA
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Veteran at least 18 years of age, enrolled in VA care, fluent in English, able to provide informed consent, own a smartphone or willing to use a study-provided smartphone, have diagnoses of current posttraumatic stress disorder (PTSD) and major depressive disorder (MDD), willing to not begin another form of Skills Training in Affective and Interpersonal Regulation (STAIR) during the study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated at end of trial (lasting approximately 2 years)

Summary

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.

Eligible Conditions
  • Post-Traumatic Stress Disorder
  • Major Depressive Disorder
  • Psychosocial Functioning

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated at end of trial (lasting approximately 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated at end of trial (lasting approximately 2 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Client Satisfaction Questionnaire-8 (CSQ-8)
Mobile Application Rating Scale User Version (uMARS)
Study Engagement Rate
+2 more
Secondary study objectives
PTSD Checklist for DSM-5 (PCL-5)
Patient Health Questionnaire-9 (PHQ-9)
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Self-Guided STAIR Coach with Real-Time AssessmentExperimental Treatment1 Intervention
Participants randomized to this condition will receive two mobile apps.
Group II: Real-Time AssessmentActive Control1 Intervention
Participants randomized to this condition will receive one mobile app.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,775 Total Patients Enrolled
Haijing Wu Hallenbeck, PhD MAPrincipal InvestigatorVA Palo Alto Health Care System, Palo Alto, CA
~27 spots leftby Apr 2029