NCT07227090

Brief Summary

The goal of this study is to learn if implementing a mental health educational resource handout will affect patient confidence, awareness, and knowledge of how to address mental health after trauma injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 12, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

November 20, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

November 5, 2025

Last Update Submit

February 20, 2026

Conditions

Injury TraumaticMental Health Issue

Outcome Measures

Primary Outcomes (2)

  • Participant confidence in accessing mental health resources

    Survey question with Likert type scale from 1 - 10 with higher scores indicating greater confidence

    Baseline

  • Participant confidence in receiving mental health support

    Survey question with Likert type scale from 1 - 10 with higher scores indicating greater confidence

    Baseline

Study Arms (2)

Standard of Care

NO INTERVENTION

Survey patients who will not receive the mental health education document

Health Education Document

EXPERIMENTAL

Survey patients who have been given the mental health education document

Behavioral: Mental Health Education Tool

Interventions

Mental Health Education ToolBEHAVIORAL

A one-page mental health educational document provided to patients that have experienced trauma injury. The document provides brief evidence-based mindfulness practices in stress reduction, as well as information on how and when to address mental health issues.

Health Education Document

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking adult trauma patients

You may not qualify if:

  • Participant less than 18 years old
  • Non-English speaking or need of translator
  • Subject doesn't complete survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Andrew Bernard, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 5, 2025

First Posted

November 12, 2025

Study Start

November 20, 2025

Primary Completion

February 16, 2026

Study Completion

February 16, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)