DepressionNCT06324383
Enhancing Purpose and Well-Being Through a Volunteering Experience Connecting Veterans With English Language Learners
A study testing Intervention (videoconferencing) in people with Depression and Anxiety, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Post Traumatic Stress Disorder
- What is being tested?
- Intervention (videoconferencing)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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
Who cannot join
- 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 --
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Center for Clinical Management Research (CCMR), North Campus Research Complex
Ann Arbor, Michigan, 48109
Sarah H Yon, MPH, 734-222-7671, shlim@med.umich.edu
About this study
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.
Read the 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.
- Conditions
- Depression, Anxiety, Post Traumatic Stress Disorder
- Being tested
- Intervention (videoconferencing)
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention (videoconferencing)Other
1 hour videoconferencing sessions over 8 weeks with an English language learner partner.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Participants will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions. Receives: Other: Intervention (videoconferencing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, pre-intervention and Follow-up, immediately after 8-week intervention
(Patient Health Questionnaire) PHQ-8
This is a 3 point scale (0= not at all, 3= nearly every day). Higher scores reflects greater depression.
Measured: Baseline, pre-intervention and Follow-up, immediately after 8-week intervention
(Generalized Anxiety Disorder) GAD-7
This is a 3 point scale (0= not at all, 3= nearly every day). Higher scores reflects greater anxiety.
Measured: Baseline, pre-intervention and Follow-up, immediately after 8-week intervention
(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.
Measured: Baseline, pre-intervention and Follow-up, immediately after 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start15 Apr 2024
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Piette, University of Michigan
- Investigators
- John D Piette, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324383
- Sponsor's protocol ID
- 1782599
- Status last verified
- May 2024
- First submitted
- 12 Mar 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Purpose and Well-Being Through a Volunteering Experience Connecting Veterans With English Language Learners
- ClinicalTrials.gov ID
- NCT06324383
- Acronym / sponsor ID
- 1782599
- Conditions
- Depression, Anxiety, Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Intervention (videoconferencing)Participants will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 18+ years of age
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention (videoconferencing)1 hour videoconferencing sessions over 8 weeks with an English language learner partner. | Other | Intervention |
Primary outcome
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.
(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.
(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.
(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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D Piette, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention (videoconferencing) in people with Depression and Anxiety, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah H Yon, MPH (734-222-7671, shlim@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
France and Finney "Mattering" (time frame: Baseline, pre-intervention and Follow-up, immediately after 8-week intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.