NCT06324383

Brief Summary

The goal of this study is to refine and test a strategy for engaging Veterans with symptoms of depression, anxiety, and/or PTSD (Post Traumatic Stress Disorder) as volunteers to help English language learners (ELLs) improve their speaking skills via structured conversations using videoconferencing.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

March 12, 2024

Last Update Submit

May 3, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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, pre-intervention and Follow-up, immediately after 8-week intervention

  • (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, pre-intervention and Follow-up, immediately after 8-week intervention

  • (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, pre-intervention and Follow-up, immediately after 8-week intervention

  • (Posttraumatic Stress Disorder Checklist) PCL-5

    PCL-5 is a 20-item self-report measure that assesses the 20 (Diagnostic and Statistical Manual) 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, pre-intervention and Follow-up, immediately after 8-week intervention

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

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • fluent English speakers
  • diagnosis of depression, anxiety, or PTSD in their outpatient record in the last 12 months.
  • 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 that significantly impedes ability to participate in sessions
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Clinical Management Research (CCMR), North Campus Research Complex

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety DisordersStress Disorders, Post-Traumatic

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • John D Piette, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah H Yon, MPH

CONTACT

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

March 12, 2024

First Posted

March 22, 2024

Study Start

April 15, 2024

Primary Completion

April 15, 2025

Study Completion

April 15, 2025

Last Updated

May 7, 2024

Record last verified: 2024-05

Locations