跳至主要内容
临床试验/NCT06324383
NCT06324383招募中不适用

Enhancing Purpose and Well-Being Through a Volunteering Experience Connecting Veterans With English Language Learners

University of Michigan2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
France and Finney "Mattering"

研究概览

简要总结

The goal of this study is to refine and test a strategy for engaging Veterans with symptoms of depression, anxiety, and/or PTSD (Post Traumatic Stress Disorder) as volunteers to help English language learners (ELLs) improve their speaking skills via structured conversations using videoconferencing.

详细描述

The investigators goal is to do interventional research addressing the loss of purpose and social isolation among Veterans with depression and anxiety disorders. Following on the recent successful pilot among Veterans with depression, anxiety, and PTSD recruited via social media, the objective of this project is to conduct an intervention pilot with 40 pairs of Veterans with diagnosed depression, generalized anxiety disorder, and/or PTSD recruited from the VA, and English-language learners (ELLs). To accomplish this goal, staff will dedicate time in areas including: (1) Tailoring training and program materials for VA patients and English language learners (ELLs). (2) Enroll 40 pairs of Veterans and ELLs in the pilot. (3) Conduct orientation and supervised sessions via videocam for pilot participants. (4) Collect baseline/follow-up data including quantitative surveys and qualitative interviews of Veteran participants and ELLs. (5) Process and analyze pilot data. (6) Prepare an (Investigator Initiated Research) IIR as well as publication.

The intervention the investigators are developing is designed to have a national impact on the loss of purpose and social isolation among Veterans by evaluating a scalable, accessible, and safe strategy for increasing social engagement and volunteerism. The pilot the investigators propose will replicate a recent successful pilot conducted among Veterans with these conditions and recruited via social media (that project was approved by the University of Michigan's Health Sciences and Behavioral Sciences (HSBS) IRB (Institutional Review Board). The primary hypothesis is that structured contact between VA system users with mood and anxiety disorders and ELLs using accessible technology will enhance Veterans' sense of life purpose or "mattering" and improve mental health symptoms. The investigators hypothesize that satisfaction levels among Veterans recruited from VA and ELLs will be high, that the majority of both groups will have the intention of maintaining social contact after the study, and that ELLs will report improvements in their English-language confidence and fluency. The proposed intervention -V-SPEAK (Veterans Service Promoting English Acquisition and Knowledge), is highly scalable because it addresses the large unmet need for both Veteran volunteerism opportunities that are remote, removing barriers that traditional volunteer opportunities have; additionally, for individuals learning English as a second language, this program provides English practice among non-native English speakers in the US.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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

入选标准

  • 18 years of age or older
  • fluent English speakers
  • diagnosis of depression, anxiety, or PTSD in their outpatient record in the last 12 months.
  • be able to participate in a videoconference via a smartphone, tablet, laptop, or desktop computer in their home using a widely-accessible, no cost videoconferencing platform.

排除标准

  • schizophrenia
  • traumatic brain injury that significantly impedes ability to participate in sessions
  • significant sensory impairment
  • current alcohol or drug abuse/dependence that would affect their ability to participate in the study
  • English Language Learner participant --
  • Inclusion Criteria:
  • 18+ years of age
  • be able to participate in a videoconference via a smartphone, tablet, laptop, or desktop computer in their home or referring organization using a widely-accessible, no cost videoconferencing platform
  • basic ability to understand and speak English

结局指标

主要结局

France and Finney "Mattering"

时间窗: Baseline, pre-intervention and Follow-up, immediately after 8-week intervention

This is a 5 point scale where the minimum is 1 (strongly disagree) and maximum is 5 (strongly agree). Higher scores reflect higher mattering, and mattering is positively related to measures of well-being.

(Generalized Anxiety Disorder) GAD-7

时间窗: Baseline, pre-intervention and Follow-up, immediately after 8-week intervention

This is a 3 point scale (0= not at all, 3= nearly every day). Higher scores reflects greater anxiety.

(Posttraumatic Stress Disorder Checklist) PCL-5

时间窗: Baseline, pre-intervention and Follow-up, immediately after 8-week intervention

PCL-5 is a 20-item self-report measure that assesses the 20 (Diagnostic and Statistical Manual) DSM-5 symptoms of PTSD. 5-point Likert (0 = "Not at all" to 4 = "Extremely"). Research on the PCL-5 suggested scores of 31 to 33 were optimally efficient for diagnosing PTSD.

(Patient Health Questionnaire) PHQ-8

时间窗: Baseline, pre-intervention and Follow-up, immediately after 8-week intervention

This is a 3 point scale (0= not at all, 3= nearly every day). Higher scores reflects greater depression.

次要结局

未报告次要终点

研究者

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

John Piette

Professor of Health Behavior and Health Education, and of Internal Medicine

University of Michigan

研究点 (2)

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