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

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

Overview

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.

Interventions

• Behavioral 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.
• Other 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.

Primary outcome measures

• Inventory of Psychosocial Functioning (IPF) [Time frame: Weeks 0 to 8, 24, and 40]

Secondary outcome measures (6)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• Syracuse VA Medical Center, Syracuse, NY — Syracuse
• Durham VA Medical Center, Durham, NC — Durham

Identifiers

NCT: NCT07202325 · RRD4-013-24W · RD000544

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗