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

NCT07202325 | Not Yet Recruiting

• 2 other identifiers: RRD4-013-24WRD000544
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Depression; Stress Disorders, Post-Traumatic

Keywords

Self-Management; Depression; Post Traumatic Stress Disorder; Veterans; Psychosocial Functioning; Clinical Trial; Psychological Intervention; Self-Help

Outcome Measures

Primary Outcomes (1)

• 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).

  Weeks 0 to 8, 24, and 40

Secondary Outcomes (6)

• Brief Symptom Inventory-18 (BSI-18) Global Severity Index

  Weeks 0 to 8, 24, and 40

• Patient Health Questionnaire-9 (PHQ-9)

  Weeks 0 to 8, 24, and 40

• Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

  Weeks 0 to 8, 24, and 40

• Columbia Suicide Severity Rating Scale (C-SSRS) item 2

  Weeks 0 to 8, 24, and 40

• Frequency of Actions and Thoughts (FATS)

  Weeks 0 to 8

Other Outcomes (5)

• RSSU part 1a: VHA Outpatient Mental Health Treatment

  Weeks 0 to 40

• RSSU part 1b: Non-VHA Outpatient Mental Health Treatment

  Weeks 0 to 40

• RSSU part 2: Other Relevant VHA Whole-Person Health Care

  Weeks 0 to 40

Study Arms (2)

Intervention condition

EXPERIMENTAL

Self-help intervention

Behavioral: Resilience Training for Veterans (REST-V)

Control condition

ACTIVE COMPARATOR

Usual resources

Other: Usual resources

Interventions

Resilience Training for Veterans (REST-V) 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.

Intervention condition

Usual resources 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.

Control condition

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210-2716, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

Depression; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Robyn L. Shepardson, PhD

  Syracuse VA Medical Center, Syracuse, NY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robyn L Shepardson, PhD

CONTACT

(315) 425-4400; Robyn.Shepardson@va.gov

Study Design

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

Model Details: Randomized clinical trial in which participants are randomized to either the intervention condition (REST-V) or control (standard resources) condition.

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): March 31, 2030
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Requests will be considered beginning 6 months after final publication. Data will be shared upon completion of a written request to the PI and within 90 days of a completed Data Use Agreement.
• Access Criteria: The Data Use Agreement (DUA) will appropriately limit use of the dataset and prohibit the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.

Locations

US (2)