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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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date April 15, 2025
Est. primary completion date April 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Veteran coach participant Inclusion Criteria: - 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. Exclusion Criteria: - schizophrenia - dementia - 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

Study Design


Intervention

Other:
Intervention (videoconferencing)
1 hour videoconferencing sessions over 8 weeks with an English language learner partner.

Locations

Country Name City State
United States Center for Clinical Management Research (CCMR), North Campus Research Complex Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary France and Finney "Mattering" 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. Baseline, pre-intervention and Follow-up, immediately after 8-week intervention
Primary (Patient Health Questionnaire) PHQ-8 This is a 3 point scale (0= not at all, 3= nearly every day). Higher scores reflects greater depression. Baseline, pre-intervention and Follow-up, immediately after 8-week intervention
Primary (Generalized Anxiety Disorder) GAD-7 This is a 3 point scale (0= not at all, 3= nearly every day). Higher scores reflects greater anxiety. Baseline, pre-intervention and Follow-up, immediately after 8-week intervention
Primary (Posttraumatic Stress Disorder Checklist) PCL-5 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. Baseline, pre-intervention and Follow-up, immediately after 8-week intervention
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