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

Not Applicable

Not yet recruiting

• Conditions: Depression; Stress Disorders, Post-Traumatic

• Registration Number: NCT07202325
• Lead Sponsor: VA Office of Research and Development

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.

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 Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-23
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Study Start: 2026-10-01
• Primary Completion: 2029-07-31
• Study Completion: 2030-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Inventory of Psychosocial Functioning (IPF)	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).

Secondary Outcome Measures

Name	Time	Method
Brief Symptom Inventory-18 (BSI-18) Global Severity Index	Weeks 0 to 8, 24, and 40	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.
Patient Health Questionnaire-9 (PHQ-9)	Weeks 0 to 8, 24, and 40	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.
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)	Weeks 0 to 8, 24, and 40	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.
Columbia Suicide Severity Rating Scale (C-SSRS) item 2	Weeks 0 to 8, 24, and 40	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.
Frequency of Actions and Thoughts (FATS)	Weeks 0 to 8	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.
Recovery Support Services Utilization (RSSU)	Weeks 0 to 40	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.

Trial Locations

Locations (2)

Syracuse VA Medical Center, Syracuse, NY; 🇺🇸 Syracuse, New York, United States

Durham VA Medical Center, Durham, NC; 🇺🇸 Durham, North Carolina, United States