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!
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
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
PTSD
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Psychological Well-Being Scale
timeFrame: Baseline and Follow-up (administered after the 8 weekly conversation sessions)
measure: France and Finney "Mattering"
timeFrame: Baseline and Follow-up (administered after the 8 weekly conversation sessions)
measure: Brief Inventory of Thriving
timeFrame: Baseline and Follow-up (administered after the 8 weekly conversation sessions)
measure: 3-item UCLA (University of California, Los Angeles) Revised Loneliness Scale
timeFrame: Baseline and Follow-up (administered after the 8 weekly conversation sessions)
measure: (Patient Health Questionnaire) PHQ-8
timeFrame: Baseline and Follow-up (administered after the 8 weekly conversation sessions)
measure: (Generalized Anxiety Disorder) GAD-7
timeFrame: Baseline and Follow-up (administered after the 8 weekly conversation sessions)
measure: (Posttraumatic Stress Disorder Checklist) PCL-5
timeFrame: Baseline and Follow-up (administered after the 8 weekly conversation sessions)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan, North Campus Research Complex
state: Michigan
Study officials:
affiliation: University of Michigan
name: John D Piette, PhD
role: PRINCIPAL_INVESTIGATOR
References: