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

NCT06689787 | Not Yet Recruiting

• 2 other identifiers: D5318-WIK2RX005318-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Veterans; Mobile Applications

Outcome Measures

Primary Outcomes (5)

• Study Recruitment Rate

  Recruitment rate will be calculated as the number of participants who are eligible for the study divided by the number of screened participants. Target feasibility benchmark is 50%.

  Evaluated at end of trial (lasting approximately 2 years)

• Study Retention Rate

  Retention rate will be calculated as the number of participants who completed the full study divided by the total number of enrolled participants. Target feasibility benchmark is 70%.

  Evaluated at end of trial (lasting approximately 2 years)

• Study Engagement Rate

  Engagement rate will refer to the mean percentage of completed STAIR Coach training plan levels and completed EMA surveys. Target feasibility benchmark is 70%.

  Evaluated at end of trial (lasting approximately 2 years)

• Mobile Application Rating Scale User Version (uMARS)

  App quality will be assessed through the Mobile Application Rating Scale User Version (uMARS). Total scores on the uMARS range from 1 to 5, with higher scores indicating higher quality. Target acceptability benchmark is a uMARS mean score of greater than or equal to 4 (indicating positive app quality).

  Post-treatment (i.e., 12 weeks after starting the trial)

• Client Satisfaction Questionnaire-8 (CSQ-8)

  Client satisfaction will be assessed through the Client Satisfaction Questionnaire-8 (CSQ-8). Total scores on the CSQ-8 range from 8 to 32, with higher scores indicating higher satisfaction. Acceptability benchmark is a CSQ-8 mean score of greater than or equal to 24 (indicating general treatment satisfaction).

  Post-treatment (i.e., 12 weeks after starting the trial)

Secondary Outcomes (3)

• PTSD Checklist for DSM-5 (PCL-5)

  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)

  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)

  Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)

Study Arms (2)

Self-Guided STAIR Coach with Real-Time Assessment

EXPERIMENTAL

Participants randomized to this condition will receive two mobile apps.

Other: Self-Guided STAIR Coach with Real-Time Assessment

Real-Time Assessment

ACTIVE COMPARATOR

Participants randomized to this condition will receive one mobile app.

Other: Real-Time Assessment

Interventions

Self-Guided STAIR Coach with Real-Time Assessment 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

Self-Guided STAIR Coach with Real-Time Assessment

Real-Time Assessment OTHER

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

Real-Time Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Study Officials

• Haijing Wu Hallenbeck, PhD MA

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haijing W Hallenbeck, PhD MA

CONTACT

(650) 387-4116; haijing.hallenbeck@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)