Clinical trial NCT06689787: A Mobile Health Intervention to Improve Psychosocial Functioning in Veterans With Posttraumatic Stress Disorder and Depression Symptoms
Official title: A Mobile Health Intervention to Improve Psychosocial Functioning in Veterans With Posttraumatic Stress Disorder and Depression Symptoms
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychosocial Functioning
Stress Disorders, Post-Traumatic
Depressive Disorder, Major
Keywords: Veterans
Mobile Applications
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

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

Primary outcomes:
measure: Study Recruitment Rate
timeFrame: Evaluated at end of trial (lasting approximately 2 years)
measure: Study Retention Rate
timeFrame: Evaluated at end of trial (lasting approximately 2 years)
measure: Study Engagement Rate
timeFrame: Evaluated at end of trial (lasting approximately 2 years)
measure: Mobile Application Rating Scale User Version (uMARS)
timeFrame: Post-treatment (i.e., 12 weeks after starting the trial)
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: Post-treatment (i.e., 12 weeks after starting the trial)
Secondary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)
measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Haijing Wu Hallenbeck, PhD MA
role: PRINCIPAL_INVESTIGATOR
References: