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临床试验/NCT05506839
NCT05506839已完成不适用

A Scalable Model for Promoting Functioning and Well-Being Among Veterans With a History of Mental Health Challenges Via Meaningful Social Interactions: Project V-SPEAK!

University of Michigan1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2022年7月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
1
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 and/or anxiety as volunteers to help English language learners (ELLs) improve their speaking skills via structured conversations using videoconferencing.

详细描述

The program to be refined and pilot tested is called V-SPEAK! - Veteran Service Promoting English Acquisition and Knowledge. Through V-SPEAK!, veterans with a history of mental health concerns will volunteer as coaches, helping English Language Learners (ELL) improve their verbal English skills via structured conversations using webcams. In August 2018, there was a focus group with veterans, including both genders, African Americans, and veterans with challenges such as generalized anxiety disorder, post-traumatic stress disorder, and depression. The group universally felt that V-SPEAK! fit well with veterans' sense of service and could be beneficial for those struggling with a loss of purpose, loneliness, and decreased self-worth. Veterans with mental disorders mentioned that the structured, bounded interactions via webcam would be an ideal way to increase social engagement without triggering anxiety or feeling overwhelmed.

The proposed study is designed to provide initial pilot data on the potential feasibility and impact of V-SPEAK! for veterans who have had mood disorders. Based on this study, there will be further refinement of the program and, if the results are positive, the investigator will seek grant funding for a more rigorous evaluation of the program's impact on outcomes. Despite the extremely encouraging experience to date recruiting participants for other similar studies (e.g., older adult volunteers with mild cognitive impairment), an important goal will be to determine whether the study can recruit and retain veterans with depression or anxiety, as well as the ELL conversation partners. Also the current V-SPEAK! orientation and session-support materials will be tailored to address the unique needs of veterans, and preliminary data on satisfaction with the V-SPEAK! experience and its impact on participants' mental health and functioning will be gathered. The study will provide vital data for the submission of a competitive application for a larger randomized trial evaluating the intervention's impact on veterans' mental health (e.g., depression, loneliness, and sense of purpose).

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
是

入选标准

  • •Veteran coach participant --
  • •Inclusion Criteria:
  • •18 years of age or older
  • •fluent English speakers
  • •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
  • •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

研究组 & 干预措施

Intervention

Other

Participants will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions.

干预措施: Intervention (videoconferencing) (Other)

结局指标

主要结局

France and Finney "Mattering"

时间窗: Baseline and Follow-up (administered after the 8 weekly conversation sessions)

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.

3-item UCLA (University of California, Los Angeles) Revised Loneliness Scale

时间窗: Baseline and Follow-up (administered after the 8 weekly conversation sessions)

This is a 3 point scale from 1=hardly ever to 3=often (minimum is 1 maximum is 3). The scores for each individually answered questions can be added together to give you a possible range of scores from 3-9. Score of 3-5 is "not lonely" and score of 6-9 is "lonely".

(Posttraumatic Stress Disorder Checklist) PCL-5

时间窗: Baseline and Follow-up (administered after the 8 weekly conversation sessions)

PCL-5 is a 20-item self-report measure that assesses the 20 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.

Psychological Well-Being Scale

时间窗: Baseline and Follow-up (administered after the 8 weekly conversation sessions)

The Psychological Wellbeing Scale (PWB) is a validated measure shown to be sensitive to intervention effects. This is a 6 point scale where the minimum is 1 (strongly disagree) and maximum is 6 (strongly agree). Higher scores reflect higher wellbeing.

(Generalized Anxiety Disorder) GAD-7

时间窗: Baseline and Follow-up (administered after the 8 weekly conversation sessions)

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

(Patient Health Questionnaire) PHQ-8

时间窗: Baseline and Follow-up (administered after the 8 weekly conversation sessions)

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

Brief Inventory of Thriving

时间窗: Baseline and Follow-up (administered after the 8 weekly conversation sessions)

This is a 5 point scale (1=strongly disagree to 5=strongly agree). Higher scores reflect a greater sense of well-being.

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 (1)

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