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Completed

NCT Number: 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!

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.

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Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders PTSD Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, North Campus Research Complex

Ann Arbor, Michigan, 48109, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention (videoconferencing)

Other

1 hour videoconferencing sessions over 8 weeks with an English language learner partner.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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".

  5. (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.

  6. (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.

  7. (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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: V-SPEAK!

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 18, 2022
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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