- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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! (V-SPEAK!)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan, North Campus Research Complex
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Veteran coach participant --
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 --
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.
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1 hour videoconferencing sessions over 8 weeks with an English language learner partner.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and Follow-up (administered after the 8 weekly conversation sessions)
|
|
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.
|
Baseline and Follow-up (administered after the 8 weekly conversation sessions)
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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.
|
Baseline and Follow-up (administered after the 8 weekly conversation sessions)
|
|
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".
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Baseline and Follow-up (administered after the 8 weekly conversation sessions)
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(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.
|
Baseline and Follow-up (administered after the 8 weekly conversation sessions)
|
|
(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.
|
Baseline and Follow-up (administered after the 8 weekly conversation sessions)
|
|
(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.
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Baseline and Follow-up (administered after the 8 weekly conversation sessions)
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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 (Actual)
Study Completion (Actual)
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
- HUM00216275
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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