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临床试验/NCT03563820
NCT03563820已完成不适用

Intervention to Improve Resilience and Mental Health in Veterans With Injury, Illness, and/or Disability

VA Puget Sound Health Care System1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2018年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
Change in Depression from Pre-Group to 5-Weeks Post-Group

研究概览

简要总结

It is common for Veterans with injuries, illnesses, or physical disabilities to experience depression, post-traumatic stress disorder (PTSD), chronic pain, and other concerns. They may also have goals like becoming happier or better able to cope with challenges that life brings. The purpose of this research study is to learn whether Veterans like and benefit from a 5-week, group-based positive psychology program aimed at improving mental health, resilience, well-being, and quality of life. Participants will be asked to complete several assessments (surveys/interviews) over the course of the study that are not considered part of standard care. Additionally, participants will be asked to participate in a focus group at the end of the study to provide feedback about their experiences in the group.

详细描述

To participate in this study, Veterans must first be enrolled in the Resilience and Well-Being Program, a 5-week, group-based positive psychology program held at VA Puget Sound as part of standard care. After enrollment, Veterans may choose to enroll in this research study which evaluates the effectiveness of, and satisfaction with, the Resilience and Well-Being Program.

This research study includes two study visits at VA Puget Sound and three assessments over the phone.

Informed Consent Process

This process will take place at the VA Puget Sound. A research staff member will review the details of the study with the participant and answer any questions s/he may have to see if they are interested in participating.

Assessments

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Veteran status (defined as prior service in the US Armed Forces and eligible to receive health care services through Veterans Health Affairs)
  • 18 years of age or older
  • Enrolled, or eligible and willing to enroll, in the Resilience and Well-Being group treatment program (offered as part of standard clinical care in VA Puget Sound Rehabilitation Care Services)
  • Able to read, speak, and understand English
  • Has been seen at least once in the past 12 months in a VAPSHCS clinic that provides rehabilitation services to individuals with rehabilitation needs related to conditions including (but not limited to) multiple sclerosis (MS), traumatic brain injury (TBI), amyotrophic lateral sclerosis (ALS), spinal cord injury (SCI), stroke, myocardial infarction, limb loss, polytrauma, neuromuscular conditions, musculoskeletal problems, impairing but medically unexplained symptoms, and/or pain, OR has a diagnosis of such a condition
  • Positive screen for depression, PTSD, or chronic pain

排除标准

  • Primary psychotic or major thought disorder as listed in participant's medical record or self-reported
  • Psychiatric or behavioral conditions in which symptoms were unstable or severe (e.g., current delirium, mania, psychosis, suicidal ideation, homicidal ideation, active substance use disorder, psychiatric hospitalization) as listed in participant's medical record or self-reported within the past six months
  • Any behavioral, cognitive, or psychiatric issues that would indicate the participant may be inappropriate in a group setting or for this particular group-format intervention, subject to clinician discretion
  • Difficulties or limitations communicating over the telephone

结局指标

主要结局

Change in Depression from Pre-Group to 5-Weeks Post-Group

时间窗: Pre-Group (up to 2-weeks prior to Session 1 of group program), Post-Group (immediately after Session 5 of group program, window open up to 4 weeks after), 5-Week Follow-Up (5 weeks after Session 5 of program, window open up to 4 weeks after)

Change in depression will be measured using the PROMIS Depression Short Form-8A. Responses from each item will be summed to form a total raw score ranging from 8-40. Higher scores indicate higher self-reported levels of depression.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Rhonda Williams, PhD

Attending Psychologist

VA Puget Sound Health Care System

研究点 (1)

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