- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06518616
Meditation to Reduce Firefighter Distress
Reducing Psychological Distress in Fire Fighters With an Asynchronous App- Based Meditation Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of this study is to test the efficacy of a 10-day meditation intervention (i.e., 10 individual prerecorded audio units delivered by smartphone app) versus an active attention control (i.e., 10-day health education intervention with 10 individual prerecorded audio units delivered by smartphone app) to reduce psychological distress among N=160 career firefighters (to address possible attrition, N=192 firefighters will be consented and enrolled). The following specific aims will guide the research:
Aim 1. Examine whether firefighters' psychological distress (i.e., features of anxiety [primary outcome], depression) is reduced at 10 days, 30 days, and 3 months after the meditation intervention versus an active attention control. Features of anxiety, features of depression will be assessed at baseline (T1), after the 10-day intervention (T2), 30 days later (T3), and 3 months later (T4).
Aim 2: Explore the extent to which reductions in psychological distress from the meditation intervention are mediated by mindfulness and perceived social connection.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Thaddeus Pace, PhD
- Phone Number: 5206263520
- Email: twwpace@arizona.edu
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85721
- Recruiting
- University of Arizona
-
Contact:
- Thaddeus Pace
- Phone Number: 520-626-3520
- Email: ffmind2@arizona.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria: 1) currently employed as a career firefighter, 2) 18 or older, 3) speak and understand English, and 4) own a smartphone (iPhone or Android) able to download and run the intervention apps.
Exclusionary factors: 1) diagnosis of an illness requiring use of corticosteroids (e.g., asthma), and 2) have ongoing or past regular meditation experience in the last 4 years (i.e. more than two meditation session [completed or attempted] per year either with a group or individually), as determined by the PI.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 10-day meditation intervention
prerecorded meditation units, 10 units, one per day, delivered by smartphone app
|
prerecorded meditation units delivered by smartphone app
|
|
Active Comparator: 10-day health education intervention
prerecorded health education units, 10 units, one per day, delivered by smartphone app
|
prerecorded health education units delivered by smartphone app
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anxiety features
Time Frame: before, immediately after, 30 days after, and 3 months after the 10-day interventions
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
depression features
Time Frame: before, immediately after, 30 days after, and 3 months after the 10-day interventions
|
PROMIS Short Form Emotional Distress - Depression - 8a
|
before, immediately after, 30 days after, and 3 months after the 10-day interventions
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thaddeus Pace, PhD, University of Arizona
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00003422
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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