A Mobile Health Intervention to Improve Psychosocial Functioning in Veterans With Posttraumatic Stress Disorder and Depression Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Self-Guided STAIR Coach with Real-Time Assessment, Real-Time Assessment.
- Who it may be relevant to
- Registry conditions: Psychosocial Functioning, Stress Disorders, Post-Traumatic, Depressive Disorder, Major. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Veterans experience high rates of posttraumatic stress disorder (PTSD) and depression, which are frequently comorbid and result in difficulties with psychosocial functioning substantially greater than either disorder alone. Functioning difficulties in Veterans have not been adequately addressed by most existing psychotherapies for PTSD and depression because they often focus on symptom improvement and are highly resource-intensive, requiring the training and time of skilled providers. To address this gap, mobile health (mHealth) apps can serve as a widely accessible, standalone or adjunctive intervention to target psychosocial functioning among Veterans with comorbid PTSD and depression. This study focuses on the evaluation of a self-guided mHealth intervention based on Skills Training in Affective and Interpersonal Regulation (STAIR), an evidence-based psychotherapy that explicitly targets functioning improvements and also alleviates PTSD and depression symptoms among trauma survivors. As part of the intervention, real-time assessment (i.e., ecological momentary assessment and passive sensing) will be incorporated to support Veterans in monitoring their functioning, symptoms, and potential benefits from STAIR. The primary goal is to determine the feasibility and acceptability of this intervention (self-guided STAIR Coach with real-time assessment).
Interventions
- Other Self-Guided STAIR Coach with Real-Time Assessment
Two mobile apps to be used as one intervention package to support participants in their progress through STAIR (Skills Training in Affective and Interpersonal Regulation) with self-monitoring of symptoms and functioning - Other Real-Time Assessment
One mobile app to support participants in self-monitoring of symptoms and functioning
Primary outcome measures
- Study Recruitment Rate [Time frame: Evaluated at end of trial (lasting approximately 2 years)]
- Study Retention Rate [Time frame: Evaluated at end of trial (lasting approximately 2 years)]
- Study Engagement Rate [Time frame: Evaluated at end of trial (lasting approximately 2 years)]
- Mobile Application Rating Scale User Version (uMARS) [Time frame: Post-treatment (i.e., 12 weeks after starting the trial)]
- Client Satisfaction Questionnaire-8 (CSQ-8) [Time frame: Post-treatment (i.e., 12 weeks after starting the trial)]
Secondary outcome measures (3)
- PTSD Checklist for DSM-5 (PCL-5) [Time frame: Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)]
- Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)]
- World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [Time frame: Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)]
Eligibility criteria
Inclusion criteria
- Veteran
- 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
Exclusion criteria
- history of mania or psychosis
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto
Identifiers
NCT: NCT06689787 · D5318-W · IK2RX005318-01A1