A Mobile Health Intervention to Improve Psychosocial Functioning in Veterans With Posttraumatic Stress Disorder and Depression Symptoms

NCT ID: NCT06689787

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2027-04-01
• Study Completion Date: 2029-04-01

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).

Conditions

Psychosocial Functioning; Stress Disorders, Post-Traumatic; Depressive Disorder, Major

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Self-Guided STAIR Coach with Real-Time Assessment

Participants randomized to this condition will receive two mobile apps.

Group Type: EXPERIMENTAL

Self-Guided STAIR Coach with Real-Time Assessment

Intervention Type: OTHER

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

Real-Time Assessment

Participants randomized to this condition will receive one mobile app.

Group Type: ACTIVE_COMPARATOR

Real-Time Assessment

Intervention Type: OTHER

One mobile app to support participants in self-monitoring of symptoms and functioning

Interventions

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

Intervention Type: OTHER

Real-Time Assessment

One mobile app to support participants in self-monitoring of symptoms and functioning

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haijing Wu Hallenbeck, PhD MA

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Locations

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Countries

United States

Central Contacts

Haijing W Hallenbeck, PhD MA

Role: CONTACT

haijing.hallenbeck@va.gov

(650) 387-4116

Facility Contacts

Haijing W Hallenbeck, PhD MA

Role: primary

haijing.hallenbeck@va.gov

650-387-4116

Other Identifiers

IK2RX005318-01A1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

D5318-W

Identifier Type: -

Identifier Source: org_study_id