Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06324383 |
| Other study ID # |
1782599 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2024 |
| Est. completion date |
April 15, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
University of Michigan |
| Contact |
Sarah H Yon, MPH |
| Phone |
734-222-7671 |
| Email |
shlim[@]umich.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
