- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06324383
Enhancing Purpose and Well-Being Through a Volunteering Experience Connecting Veterans With English Language Learners
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sarah H Yon, MPH
- Phone Number: 734-222-7671
- Email: shlim@umich.edu
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48109
- Recruiting
- Center for Clinical Management Research (CCMR), North Campus Research Complex
-
Contact:
- Sarah H Yon, MPH
- Phone Number: 734-222-7671
- Email: shlim@med.umich.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intervention
Participants will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions.
|
1 hour videoconferencing sessions over 8 weeks with an English language learner partner.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
France and Finney "Mattering"
Time Frame: 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.
|
Baseline, pre-intervention and Follow-up, immediately after 8-week intervention
|
(Patient Health Questionnaire) PHQ-8
Time Frame: 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.
|
Baseline, pre-intervention and Follow-up, immediately after 8-week intervention
|
(Generalized Anxiety Disorder) GAD-7
Time Frame: 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.
|
Baseline, pre-intervention and Follow-up, immediately after 8-week intervention
|
(Posttraumatic Stress Disorder Checklist) PCL-5
Time Frame: 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.
|
Baseline, pre-intervention and Follow-up, immediately after 8-week intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John D Piette, PhD, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1782599
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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