DepressionNCT07202325
Self-Help Intervention for Post 9/11 Veterans With Depression or PTSD Symptoms
A study testing Resilience Training for Veterans (REST-V) and Usual resources in people with Depression and Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
It is important to provide support and resources for the many post-9/11 Veterans with mental health symptoms and poor psychosocial functioning who do not engage in psychotherapy. One of the biggest reasons post-9/11 Veterans do not seek treatment is a preference to handle problems on their own. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Stress Disorders, Post-Traumatic
- What is being tested?
- Resilience Training for Veterans (REST-V) and Usual resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2027to 30 Aug 2030
- 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 age >= 18 years who served on or after September 11, 2001
- Enrolled at Syracuse or Durham VA Healthcare System (had an encounter in primary care or Military 2VA clinic in past 24 months)
- Screen positive for current symptoms of MDD (PHQ-2) or PTSD (PC-PTSD-5)
- Report current functional impairment (PHQ-9 item 10)
Who cannot join
- Inability to communicate in English
- Visual impairment that precludes reading self-help materials
- Hearing impairment that precludes completing telephone assessments
- Cognitive impairment that precludes providing informed consent
- Serious mental illness (diagnosis of bipolar disorder or schizophrenia spectrum and other psychotic disorders)
- Engaged in psychotherapy/counseling (>= 2 outpatient therapy visits in past 90 days, scheduled outpatient therapy visit in upcoming 30 days that intends to attend, or psychiatric hospitalization in past 90 days)
- Started or had dosage change in psychotropic medication in the past 4 weeks
- At imminent risk of suicide or has active high-risk for suicide flag
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
Patrick Calhoun, PhD, 919-286-0411 ext. 7970, Patrick.Calhoun2@va.gov
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210-2716
Robyn L Shepardson, PhD, (315) 425-4400 ext. 53519, Robyn.Shepardson@va.gov
Robyn L. Shepardson, PhD
About this study
Official title: A Self-Help Intervention to Improve Functioning, Symptoms, and Treatment Utilization Among Non-Treatment Engaged Post 9/11 Veterans With Depression or PTSD Symptoms
It is important to provide support and resources for the many post-9/11 Veterans with mental health symptoms and poor psychosocial functioning who do not engage in psychotherapy. One of the biggest reasons post-9/11 Veterans do not seek treatment is a preference to handle problems on their own. This study examines a self-help intervention that teaches Veterans healthy coping strategies they can use on their own and how to seek out recovery support services such as mental health treatment or whole-person care if they decide to do so in the future. This study will compare the impact of self-help and standard resources at improving mental health and resource utilization. Two hundred Veterans will complete 6 brief assessments across 40 weeks.
Read the detailed description
Many post-9/11 Veterans experience impaired psychosocial functioning, due in part to high rates of posttraumatic stress disorder (PTSD) and major depressive disorder (MDD). Less than half of post-9/11 Veterans with these conditions seek mental health treatment, with key barriers being a preference to self-manage and lack of time. Veterans also report difficulty navigating the overwhelming array of resources available. To address this gap for post-9/11 Veterans with unmet mental health needs, the investigators developed a self-help intervention to provide skills for healthy self-management as well as curated guidance on recovery support services that address mental health and broader whole-person functional challenges. The investigators will compare the self-help intervention to a control condition of standard printed resource/treatment information as is provided in usual care. The objective of this clinical trial is to evaluate the efficacy of the intervention (vs. control) at improving psychosocial functional impairment, mental health outcomes, and utilization of cognitive-behavioral coping skills and recovery support services. The investigators will also explore use of coping skills and recovery support services as potential mediators of the intervention. A total of 200 Veterans from the Syracuse and Durham VA healthcare system will complete validated measures in 6 assessments over 40 weeks.
- Conditions
- Depression, Stress Disorders, Post-Traumatic
- Being tested
- Resilience Training for Veterans (REST-V), Usual resources
- Keywords
- Self-Management, Depression, Post Traumatic Stress Disorder, Veterans, Psychosocial Functioning, Clinical Trial, Psychological Intervention, Self-Help
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience Training for Veterans (REST-V)Behavioural
A 6-week self-help intervention tailored for post-9/11 Veterans offering guidance on cognitive-behavioral self-management coping strategies plus when and how to access recovery support services including mental health treatment. Materials are sent once a week for 6 weeks, and participants can opt to receive weekly reminder text messages or up to 3 brief telephone support calls.
Usual resourcesOther
Standard printed resource/treatment information provided in VHA usual care to post-9/11 Veterans. Covers similar domains as the intervention materials and provides information on a variety of VA and community resources for Veterans. Materials are sent once.
| Study group | Role | What they receive |
|---|---|---|
| Intervention condition | Experimental | Self-help intervention Receives: Behavioral: Resilience Training for Veterans (REST-V) |
| Control condition | Active comparator | Usual resources Receives: Other: Usual resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inventory of Psychosocial Functioning (IPF)
An 80-item self-report measure of mental-health related psychosocial functional impairment over the past 30 days. The IPF yields domain scores for up to 7 domains (e.g., work, family, self care), with only those domains relevant for the individual being scored, and an overall score. The overall IPF score is an unweighted average of all calculated domain scores, scaled to a range of 0-100. Higher scores indicate greater psychosocial functional impairment (i.e., lower scores = better functioning).
Measured: Weeks 0 to 8, 24, and 40
Secondary outcomes (6)
Brief Symptom Inventory-18 (BSI-18) Global Severity Index
An 18-item self-report measure of general psychological distress over the past 7 days serves as a cross-cutting mental health outcome not specific to any one mental health diagnosis. The Global Severity Index (GSI) uses all three 6-item subscales (depression, anxiety, somatization), with a total raw score range of 0-72. Raw scores can be converted to T-scores using normative data. Higher scores indicate greater distress.
Measured: Weeks 0 to 8, 24, and 40
Patient Health Questionnaire-9 (PHQ-9)
A 9-item self-report measure of depression symptom severity over the past 2 weeks. The total PHQ-9 score is the sum of all 9 items and can range from 0-27. Higher scores indicate greater depression symptom severity.
Measured: Weeks 0 to 8, 24, and 40
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
A 20-item self-report measure of PTSD symptom severity over the past month. The total PCL-5 score is the sum of all 20 items and can range from 0-80. Higher scores indicate greater PTSD symptom severity.
Measured: Weeks 0 to 8, 24, and 40
Columbia Suicide Severity Rating Scale (C-SSRS) item 2
This self-report item assesses suicidal ideation over the past month with yes or no response options. The full C-SSRS used in VHA will be administered, but this outcome focuses specifically on active suicidal ideation.
Measured: Weeks 0 to 8, 24, and 40
Frequency of Actions and Thoughts (FATS)
An 12-item self-report measure of frequency of cognitive-behavioral therapy (CBT) skill utilization over the past week. This measure is sensitive to change from CBT self-help. The total FATS score is the sum of all 12 items (from 4 subscales) and can range from 0 to 48. Higher scores indicate greater frequency of CBT skill utilization.
Measured: Weeks 0 to 8
Recovery Support Services Utilization (RSSU)
The investigators will use cumulative measures of utilization of 3 components across the 40-week study: (1) outpatient mental health treatment (a) within VHA and (b) outside VHA, (2) other relevant VHA whole-person health care, and (3) informal resources. See the other pre-specified outcomes with prefix RSSU below for details on measurement of each component.
Measured: Weeks 0 to 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Mar 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Model description
- Randomized clinical trial in which participants are randomized to either the intervention condition (REST-V) or control (standard resources) condition.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Robyn L. Shepardson, PhD, Principal investigator, Syracuse VA Medical Center, Syracuse, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202325
- Sponsor's protocol ID
- RRD4-013-24W
- Other IDs
- RD000544
- Status last verified
- Aug 2026
- First submitted
- 23 Sep 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final data sets underlying all publications resulting from the research may be shared outside VA. A Limited Dataset (LDS) that does not contain any personally identifiable information (PII) will be created and shared pursuant to a completed written Data Use Agreement (DUA) with the PI.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-Help Intervention to Improve Functioning, Symptoms, and Treatment Utilization Among Non-Treatment Engaged Post 9/11 Veterans With Depression or PTSD Symptoms
- ClinicalTrials.gov ID
- NCT07202325
- Acronym / sponsor ID
- RRD4-013-24W
- Conditions
- Depression, Stress Disorders, Post-Traumatic
- Keywords
- Self-Management, Depression, Post Traumatic Stress Disorder, Veterans, Psychosocial Functioning, Clinical Trial, Psychological Intervention, Self-Help
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 1 Oct 2025 (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.
It is important to provide support and resources for the many post-9/11 Veterans with mental health symptoms and poor psychosocial functioning who do not engage in psychotherapy. One of the biggest reasons post-9/11 Veterans do not seek treatment is a preference to handle problems on their own. This study examines a self-help intervention that teaches Veterans healthy coping strategies they can use on their own and how to seek out recovery support services such as mental health treatment or whole-person care if they decide to do so in the future. This study will compare the impact of self-help and standard resources at improving mental health and resource utilization. Two hundred Veterans will complete 6 brief assessments across 40 weeks.
Detailed description
Many post-9/11 Veterans experience impaired psychosocial functioning, due in part to high rates of posttraumatic stress disorder (PTSD) and major depressive disorder (MDD). Less than half of post-9/11 Veterans with these conditions seek mental health treatment, with key barriers being a preference to self-manage and lack of time. Veterans also report difficulty navigating the overwhelming array of resources available. To address this gap for post-9/11 Veterans with unmet mental health needs, the investigators developed a self-help intervention to provide skills for healthy self-management as well as curated guidance on recovery support services that address mental health and broader whole-person functional challenges. The investigators will compare the self-help intervention to a control condition of standard printed resource/treatment information as is provided in usual care. The objective of this clinical trial is to evaluate the efficacy of the intervention (vs. control) at improving psychosocial functional impairment, mental health outcomes, and utilization of cognitive-behavioral coping skills and recovery support services. The investigators will also explore use of coping skills and recovery support services as potential mediators of the intervention. A total of 200 Veterans from the Syracuse and Durham VA healthcare system will complete validated measures in 6 assessments over 40 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial in which participants are randomized to either the intervention condition (REST-V) or control (standard resources) condition.
| Arm | Type | Receives |
|---|---|---|
| Intervention condition | Experimental | Behavioral: Resilience Training for Veterans (REST-V)Self-help intervention |
| Control condition | Active comparator | Other: Usual resourcesUsual resources |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veteran age >= 18 years who served on or after September 11, 2001
- Enrolled at Syracuse or Durham VA Healthcare System (had an encounter in primary care or Military 2VA clinic in past 24 months)
- Screen positive for current symptoms of MDD (PHQ-2) or PTSD (PC-PTSD-5)
- Report current functional impairment (PHQ-9 item 10)
Key exclusion criteria (8 listed)
- Inability to communicate in English
- Visual impairment that precludes reading self-help materials
- Hearing impairment that precludes completing telephone assessments
- Cognitive impairment that precludes providing informed consent
- Serious mental illness (diagnosis of bipolar disorder or schizophrenia spectrum and other psychotic disorders)
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 |
|---|---|---|
| Resilience Training for Veterans (REST-V)A 6-week self-help intervention tailored for post-9/11 Veterans offering guidance on cognitive-behavioral self-management coping strategies plus when and how to access recovery support services including mental health treatment. Materials are sent once a week for 6 weeks, and participants can opt to receive weekly reminder text messages or up to 3 brief telephone support calls. | Behavioural | Intervention condition |
| Usual resourcesStandard printed resource/treatment information provided in VHA usual care to post-9/11 Veterans. Covers similar domains as the intervention materials and provides information on a variety of VA and community resources for Veterans. Materials are sent once. | Other | Control condition |
Primary outcome
Inventory of Psychosocial Functioning (IPF)
Time frame: Weeks 0 to 8, 24, and 40
An 80-item self-report measure of mental-health related psychosocial functional impairment over the past 30 days. The IPF yields domain scores for up to 7 domains (e.g., work, family, self care), with only those domains relevant for the individual being scored, and an overall score. The overall IPF score is an unweighted average of all calculated domain scores, scaled to a range of 0-100. Higher scores indicate greater psychosocial functional impairment (i.e., lower scores = better functioning).
6 secondary outcomes
Brief Symptom Inventory-18 (BSI-18) Global Severity Index
Time frame: Weeks 0 to 8, 24, and 40
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Weeks 0 to 8, 24, and 40
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: Weeks 0 to 8, 24, and 40
Columbia Suicide Severity Rating Scale (C-SSRS) item 2
Time frame: Weeks 0 to 8, 24, and 40
Frequency of Actions and Thoughts (FATS)
Time frame: Weeks 0 to 8
Recovery Support Services Utilization (RSSU)
Time frame: Weeks 0 to 40
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 1 Sep 2026.
- Individual participant dataSharing planned: Yes. Final data sets underlying all publications resulting from the research may be shared outside VA. A Limited Dataset (LDS) that does not contain any personally identifiable information (PII) will be created and shared pursuant to a completed written Data Use Agreement (DUA) with the PI.
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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.
Robyn L. Shepardson, PhD principal investigator
Syracuse VA Medical Center, Syracuse, NY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience Training for Veterans (REST-V) and Usual resources in people with Depression and Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 2 sites 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 4 inclusion and 8 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Robyn L Shepardson, PhD ((315) 425-4400 ext. 53519, Robyn.Shepardson@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inventory of Psychosocial Functioning (IPF) (time frame: Weeks 0 to 8, 24, and 40). 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 1 Sep 2026; AzTrials last refreshed its copy on 28 Oct 2026.