Depression, AnxietyV-SPEAK!NCT05506839
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!
A study testing Intervention (videoconferencing) in people with Depression, Anxiety and PTSD, 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 and/or anxiety 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, PTSD
- What is being tested?
- Intervention (videoconferencing)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2022to 8 Aug 2023
- 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
- 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
- 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
University of Michigan, North Campus Research Complex
Ann Arbor, Michigan, 48109
About this study
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.
Read the detailed description
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).
- Conditions
- Depression, Anxiety, PTSD
- 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.
Psychological Well-Being Scale
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.
Measured: Baseline and Follow-up (administered after the 8 weekly conversation sessions)
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 and Follow-up (administered after the 8 weekly conversation sessions)
Brief Inventory of Thriving
This is a 5 point scale (1=strongly disagree to 5=strongly agree). Higher scores reflect a greater sense of well-being.
Measured: Baseline and Follow-up (administered after the 8 weekly conversation sessions)
3-item UCLA (University of California, Los Angeles) Revised Loneliness Scale
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".
Measured: Baseline and Follow-up (administered after the 8 weekly conversation sessions)
(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 and Follow-up (administered after the 8 weekly conversation sessions)
(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 and Follow-up (administered after the 8 weekly conversation sessions)
(Posttraumatic Stress Disorder Checklist) PCL-5
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.
Measured: Baseline and Follow-up (administered after the 8 weekly conversation sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start29 Jul 2022
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies 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
- 88 participants (actual)
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
- NCT05506839
- Sponsor's protocol ID
- HUM00216275
- Acronym
- V-SPEAK!
- Status last verified
- Sep 2023
- First submitted
- 15 Aug 2022
- Last updated
- 8 Sep 2023
- 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 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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!
- ClinicalTrials.gov ID
- NCT05506839
- Acronym / sponsor ID
- V-SPEAK! / HUM00216275
- Conditions
- Depression, Anxiety, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 18 Aug 2022 (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 and/or anxiety as volunteers to help English language learners (ELLs) improve their speaking skills via structured conversations using videoconferencing.
Detailed description
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).
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 (6 listed)
- 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.
- 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
Key exclusion criteria (6 listed)
- schizophrenia
- dementia
- traumatic brain injury
- 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
Psychological Well-Being Scale
Time frame: 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.
France and Finney "Mattering"
Time frame: 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.
Brief Inventory of Thriving
Time frame: 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.
3-item UCLA (University of California, Los Angeles) Revised Loneliness Scale
Time frame: 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".
(Patient Health Questionnaire) PHQ-8
Time frame: 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.
(Generalized Anxiety Disorder) GAD-7
Time frame: 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.
(Posttraumatic Stress Disorder Checklist) PCL-5
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
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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, Anxiety and PTSD, 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 6 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: finished, as of the sponsor's last update on 8 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Well-Being Scale (time frame: Baseline and Follow-up (administered after the 8 weekly conversation sessions)). The study lists 7 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 8 Sep 2023.