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!

PTSD Clinical Trial

— 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!

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05506839
• Other study ID #: HUM00216275
• Status: Completed
• Phase: N/A
• Start date: July 29, 2022
• Est. completion date: August 8, 2023

Study information

• Verified date: September 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 8, 2023
• Est. primary completion date: August 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• PTSD

Intervention

Other:
• Intervention (videoconferencing)
1 hour videoconferencing sessions over 8 weeks with an English language learner partner.

Locations

Country	Name	City	State
United States	University of Michigan, North Campus Research Complex	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Follow-up (administered after the 8 weekly conversation sessions)
Primary	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.	Baseline and Follow-up (administered after the 8 weekly conversation sessions)
Primary	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.	Baseline and Follow-up (administered after the 8 weekly conversation sessions)
Primary	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".	Baseline and Follow-up (administered after the 8 weekly conversation sessions)
Primary	(Patient Health Questionnaire) PHQ-8	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)
Primary	(Generalized Anxiety Disorder) GAD-7	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)
Primary	(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.	Baseline and Follow-up (administered after the 8 weekly conversation sessions)