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

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VA Office of Research and Development

Status

Begins enrollment in 7 months

Conditions

Stress Disorders, Post-Traumatic
Depression

Treatments

Behavioral: Resilience Training for Veterans (REST-V)
Other: Usual resources

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT07202325
RD000544 (Other Grant/Funding Number)
RRD4-013-24W

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Intervention condition
Experimental group
Description:
Self-help intervention
Treatment:
Behavioral: Resilience Training for Veterans (REST-V)
Control condition
Active Comparator group
Description:
Usual resources
Treatment:
Other: Usual resources

Trial contacts and locations

2

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Central trial contact

Robyn L Shepardson, PhD

Data sourced from clinicaltrials.gov

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