NCT06518616

Brief Summary

The more than one million firefighters in the United States provide critical emergency medical services in communities they serve and are on the front lines of healthcare delivery, including in the post-pandemic world. As a result of exposure to occupational stressors, a high proportion of firefighters experience considerable stress-related burden including psychological distress (i.e., increased features of anxiety and depression). To address this need, this project will test the efficacy of a 10-day meditation intervention (i.e., 10 individual prerecorded audio units delivered by smartphone app) among career firefighters to decrease psychological distress (i.e., anxiety and depression).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P75+ for phase_2

Timeline
10mo left

Started Dec 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Dec 2024Feb 2027

First Submitted

Initial submission to the registry

July 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

December 3, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

July 18, 2024

Last Update Submit

November 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • anxiety features

    PROMIS (Patient Reported Outcomes Measurement Information System) Short Form Emotional Distress - Anxiety - 8a

    before, immediately after, 30 days after, and 3 months after the 10-day interventions

Secondary Outcomes (1)

  • depression features

    before, immediately after, 30 days after, and 3 months after the 10-day interventions

Study Arms (2)

10-day meditation intervention

EXPERIMENTAL

prerecorded meditation units, 10 units, one per day, delivered by smartphone app

Behavioral: 10-day meditation intervention

10-day health education intervention

ACTIVE COMPARATOR

prerecorded health education units, 10 units, one per day, delivered by smartphone app

Behavioral: 10-day health education intervention

Interventions

prerecorded meditation units delivered by smartphone app

10-day meditation intervention

prerecorded health education units delivered by smartphone app

10-day health education intervention

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

RECRUITING

Study Officials

  • Thaddeus Pace, PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thaddeus Pace, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2024

First Posted

July 24, 2024

Study Start

December 3, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

November 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations