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!

NCT05506839 | Completed

• 1 other identifier: HUM00216275
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Anxiety; PTSD

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• (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)

• (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)

• (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)

Study Arms (1)

Intervention

OTHER

Participants will be paired with an English language learner and engage in 8 weeks, 1 hour videoconferencing sessions.

Other: Intervention (videoconferencing)

Interventions

Intervention (videoconferencing) OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 --
• + 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan, North Campus Research Complex

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• John D Piette, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health Behavior and Health Education, and of Internal Medicine

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 18, 2022
• Study Start: July 29, 2022
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

US (1)