A Self-Help Intervention to Improve Functioning, Symptoms, and Treatment Utilization Among Non-Treatment Engaged Post 9/11 Veterans With Depression or PTSD Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Inventory of Psychosocial Functioning (IPF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Intervention condition
Self-help intervention
干预措施: Resilience Training for Veterans (REST-V) (Behavioral)
Control condition
Usual resources
干预措施: Usual resources (Other)
结局指标
主要结局
Inventory of Psychosocial Functioning (IPF)
时间窗: 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).
次要结局
- 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)
- Recovery Support Services Utilization (RSSU)(Weeks 0 to 40)