Self-Help Intervention for Post 9/11 Veterans With Depression or PTSD Symptoms

NCT ID: NCT07202325

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-10-01

Study Completion Date

2030-03-31

Brief Summary

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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

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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

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Depression Stress Disorders, Post-Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial in which participants are randomized to either the intervention condition (REST-V) or control (standard resources) condition.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention condition

Self-help intervention

Group Type EXPERIMENTAL

Resilience Training for Veterans (REST-V)

Intervention Type BEHAVIORAL

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.

Control condition

Usual resources

Group Type ACTIVE_COMPARATOR

Usual resources

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Usual resources

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robyn L. Shepardson, PhD

Role: PRINCIPAL_INVESTIGATOR

Syracuse VA Medical Center, Syracuse, NY

Locations

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Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, United States

Site Status

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Site Status

Countries

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United States

Central Contacts

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Robyn L Shepardson, PhD

Role: CONTACT

(315) 425-4400 ext. 53956

Facility Contacts

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Robyn L Shepardson, PhD

Role: primary

315-425-4400 ext. 53956

Patrick Calhoun, PhD

Role: primary

919-286-0411 ext. 7970

Other Identifiers

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RD000544

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RRD4-013-24W

Identifier Type: -

Identifier Source: org_study_id

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