Psychosocial FunctioningNCT06689787
A Mobile Health Intervention to Improve Psychosocial Functioning in Veterans With Posttraumatic Stress Disorder and Depression Symptoms
A study testing Self-Guided STAIR Coach with Real-Time Assessment and Real-Time Assessment in people with Psychosocial Functioning and Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosocial Functioning, Stress Disorders, Post-Traumatic, Depressive Disorder, Major
- What is being tested?
- Self-Guided STAIR Coach with Real-Time Assessment and Real-Time Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2027to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
Haijing W Hallenbeck, PhD MA, (650) 387-4116, haijing.hallenbeck@va.gov
Haijing Wu Hallenbeck, PhD MA
About this study
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.
Read the 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).
- Being tested
- Self-Guided STAIR Coach with Real-Time Assessment, Real-Time Assessment
- Keywords
- Veterans, Mobile Applications
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Guided STAIR Coach with Real-Time AssessmentOther
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 AssessmentOther
One mobile app to support participants in self-monitoring of symptoms and functioning
| Study group | Role | What they receive |
|---|---|---|
| Self-Guided STAIR Coach with Real-Time Assessment | Experimental | Participants randomized to this condition will receive two mobile apps. Receives: Other: Self-Guided STAIR Coach with Real-Time Assessment |
| Real-Time Assessment | Active comparator | Participants randomized to this condition will receive one mobile app. Receives: Other: Real-Time Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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%.
Measured: 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%.
Measured: 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).
Measured: 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).
Measured: Post-treatment (i.e., 12 weeks after starting the trial)
Secondary outcomes (3)
PTSD Checklist for DSM-5 (PCL-5)
PTSD symptoms will be assessed through the PTSD Checklist for DSM-5 (PCL-5). Total scores on the PCL-5 range from 0 to 80, with higher scores indicating greater PTSD symptoms. The focus will be on evaluating effect sizes and not statistical significance. Effect sizes will be inspected to see whether they are in the expected direction and larger for the intervention condition compared to the control condition.
Measured: 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)
Depression symptoms will be assessed through the Patient Health Questionnaire-9 (PHQ-9). Total scores on the PHQ-9 range from 0 to 27, with higher scores indicating greater depression symptoms. The focus will be on evaluating effect sizes and not statistical significance. Effect sizes will be inspected to see whether they are in the expected direction and larger for the intervention condition compared to the control condition.
Measured: 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)
Psychosocial functioning impairment will be assessed through the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Total scores on the WHODAS 2.0 range from 0 to 144, with higher scores indicating greater functioning impairment. The focus will be on evaluating effect sizes and not statistical significance. Effect sizes will be inspected to see whether they are in the expected direction and larger for the intervention condition compared to the control condition.
Measured: Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Apr 2027 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial FunctioningStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Haijing Wu Hallenbeck, PhD MA, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689787
- Sponsor's protocol ID
- D5318-W
- Other IDs
- IK2RX005318-01A1
- Status last verified
- Sep 2026
- First submitted
- 12 Nov 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Health Intervention to Improve Psychosocial Functioning in Veterans With Posttraumatic Stress Disorder and Depression Symptoms
- ClinicalTrials.gov ID
- NCT06689787
- Acronym / sponsor ID
- D5318-W
- Keywords
- Veterans, Mobile Applications
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Guided STAIR Coach with Real-Time Assessment | Experimental | Other: Self-Guided STAIR Coach with Real-Time AssessmentParticipants randomized to this condition will receive two mobile apps. |
| Real-Time Assessment | Active comparator | Other: Real-Time AssessmentParticipants randomized to this condition will receive one mobile app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Veteran
- enrolled in VA care
- fluent in English
- able to provide informed consent
- own a smartphone or willing to use a study-provided smartphone
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Guided STAIR Coach with Real-Time AssessmentTwo 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 | Self-Guided STAIR Coach with Real-Time Assessment |
| Real-Time AssessmentOne mobile app to support participants in self-monitoring of symptoms and functioning | Other | Real-Time Assessment |
Primary outcome
Study Recruitment Rate
Time frame: Evaluated at end of trial (lasting approximately 2 years)
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%.
Study Retention Rate
Time frame: Evaluated at end of trial (lasting approximately 2 years)
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%.
Study Engagement Rate
Time frame: Evaluated at end of trial (lasting approximately 2 years)
Engagement rate will refer to the mean percentage of completed STAIR Coach training plan levels and completed EMA surveys. Target feasibility benchmark is 70%.
Mobile Application Rating Scale User Version (uMARS)
Time frame: Post-treatment (i.e., 12 weeks after starting the trial)
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).
Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: Post-treatment (i.e., 12 weeks after starting the trial)
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).
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haijing Wu Hallenbeck, PhD MA principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Guided STAIR Coach with Real-Time Assessment and Real-Time Assessment in people with Psychosocial Functioning and Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haijing W Hallenbeck, PhD MA ((650) 387-4116, haijing.hallenbeck@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Recruitment Rate (time frame: Evaluated at end of trial (lasting approximately 2 years)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.