Improving Quality-of-life and Depressive Symptoms for OEF/OIF Combat Veterans: Assessing the Benefits of Interactive, Internet-based Psychotherapy and Peer-to-peer Support
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Center for Epidemiologic Studies Depression Scale 10 (CES-D 10)
研究概览
简要总结
Background: Current military involvement in Afghanistan (Operation Enduring Freedom - OEF) and Iraq (Operation Iraqi Freedom - OIF) has created unforeseen burdens on the mental health and well-being of US service women and men. Although OEF/OIF service members and veterans are at high risk of developing sub-threshold combat stress and depressive symptoms or full disorders in the post-deployment period, only a small fraction ever receive care. The VETS PREVAIL Intervention, which combines Cognitive-Behavioral-Therapy-based (CBT-based) coping skills training with peer-to-peer support and counseling, was specifically designed to offer the returning OEF/OIF service member or veteran an accessible and confidential first step to care.
Evaluation Study: RISE Consulting, lead by Dr. Benjamin W. Van Voorhees, MD, MPH, was contracted to supervise a pilot study of potential benefit, feasibility and safety of the VETS PREVAIL Intervention. The study would consist of a single group pre/post comparison study of N=50 recent OEF/OIF veterans in the frame work of a phase 1 clinical trial (phase 1). Feasibility (adherence and satisfaction), evidence of clinical benefit would be evaluated through changes in the following clinical self-report measures: i) symptoms of depressed mood (Center for Epidemiologic Studies Depression Scale, CES-D), ii) post traumatic stress disorder (Post Traumatic Stress Disorder Checklist-Military, PCL-M), and iii) functional status (Short Form 12, SF-12), as well as changes in key attitudes toward mental health care seeking (intent to seek treatment, mental health self-efficacy and stigma).
详细描述
Intervention overview content and design:
The intervention, VETS PREVAIL, will empower the user to gain control over life problems through enhancement of coping strategies, self-care, social support, and a repertoire of problems solving skills in an interactive internet intervention. This intervention will have two components: internet delivery of the intervention and brief person-to-person electronic contact structured around ensuring effective motivation, engagement, and completion. The coaching model for the person-to-person contact will be based on motivational interviewing with masters level social workers , as well as contact with peers who have completed the Vet-to-Vet certificate program offered by the Depression and Bipolar Support Alliance (DBSA). The internet component is focused on combat stress, self-assessment, coping strategies, problem solving, and social support.
Trainer Role:
During the 6 weeks of Vets Prevail a trainer, a masters level social worker, will engage with subjects through one online chat per week, post lesson (approximately 15 minute time blocks; duration will vary per subject). The total amount of person-to-person contact time, with a trainer, is an estimated 90 minutes throughout the 6 week program; contact time may vary per subject. The trainer will use motivational interviewing to clarify concepts within each week's lesson. In addition, the trainer will be responsible for making referrals and follow ups, when needed.
Masters level social work education trains people to use evidence-based knowledge derived from research, practice evaluation and theories of human development and behavior and social systems to analyze complex situations between individuals and their environment, in addition to facilitating individual, organizational, social and cultural changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •>=18 years of age
- •A veteran of the U.S. military having served in the Iraq or Afghanistan theaters in the last 5 years.
- •CES-D(20) score >8
- •Access to high-speed internet
- •Own a cell phone with text message capability
- •speak and read the English language
排除标准
- •psychiatric hospitalizations within past 10 years
- •any past suicide attempt
- •diagnoses of schizophrenia or bipolar disorder
- •CES-D(20) score >36
- •discontinued or altered dosage of medication within 10 days prior to enrollment
- •score >=2 on the alcohol/drug assessment
结局指标
主要结局
Center for Epidemiologic Studies Depression Scale 10 (CES-D 10)
时间窗: baseline, 4 weeks, 8 weeks, 12 weeks
The Center for Epidemiologic Studies Depression Scale (CES-D) is one of the most common screening tests for helping an individual to determine his or her depression quotient. The quick self-test measures depressive feelings and behaviours during the past week.
次要结局
- Post Traumatic Stress Disorder Checklist-Military (PCL-M)(baseline, week 4, week 8, week 12)
- 12-Item Short Form Health Survey (SF-12)(baseline, week 4, week 8, week 12)