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!)
Primary Purpose
Depression, Anxiety, PTSD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention (videoconferencing)
Sponsored by
About this trial
This is an interventional health services research trial for Depression, Anxiety
Eligibility Criteria
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
Sites / Locations
- University of Michigan, North Campus Research Complex
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention
Arm Description
Participants will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions.
Outcomes
Primary Outcome Measures
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.
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.
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.
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".
(Patient Health Questionnaire) PHQ-8
This is a 3 point scale (0= not at all, 3= nearly every day). Higher scores reflects greater depression.
(Generalized Anxiety Disorder) GAD-7
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05506839
First Posted
August 15, 2022
Last Updated
September 5, 2023
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT05506839
Brief 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!
Acronym
V-SPEAK!
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!
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 29, 2022 (Actual)
Primary Completion Date
August 8, 2023 (Actual)
Study Completion Date
August 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, PTSD
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Arm Description
Participants will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions.
Intervention Type
Other
Intervention Name(s)
Intervention (videoconferencing)
Intervention Description
1 hour videoconferencing sessions over 8 weeks with an English language learner partner.
Primary Outcome Measure Information:
Title
Psychological Well-Being Scale
Description
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.
Time Frame
Baseline and Follow-up (administered after the 8 weekly conversation sessions)
Title
France and Finney "Mattering"
Description
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.
Time Frame
Baseline and Follow-up (administered after the 8 weekly conversation sessions)
Title
Brief Inventory of Thriving
Description
This is a 5 point scale (1=strongly disagree to 5=strongly agree). Higher scores reflect a greater sense of well-being.
Time Frame
Baseline and Follow-up (administered after the 8 weekly conversation sessions)
Title
3-item UCLA (University of California, Los Angeles) Revised Loneliness Scale
Description
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".
Time Frame
Baseline and Follow-up (administered after the 8 weekly conversation sessions)
Title
(Patient Health Questionnaire) PHQ-8
Description
This is a 3 point scale (0= not at all, 3= nearly every day). Higher scores reflects greater depression.
Time Frame
Baseline and Follow-up (administered after the 8 weekly conversation sessions)
Title
(Generalized Anxiety Disorder) GAD-7
Description
This is a 3 point scale (0= not at all, 3= nearly every day). Higher scores reflects greater anxiety.
Time Frame
Baseline and Follow-up (administered after the 8 weekly conversation sessions)
Title
(Posttraumatic Stress Disorder Checklist) PCL-5
Description
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.
Time Frame
Baseline and Follow-up (administered after the 8 weekly conversation sessions)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Piette, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan, North Campus Research Complex
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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!
We'll reach out to this number within 24 hrs