Psychological DistressPhase 2NCT06518616
Meditation to Reduce Firefighter Distress
A Phase 2 study testing 10-day meditation intervention and 10-day health education intervention in people with Psychological Distress, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress
- What is being tested?
- 10-day meditation intervention and 10-day health education intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2024to 30 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Psychological Distress in Fire Fighters With an Asynchronous App- Based Meditation Intervention
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).
Read the 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.
- Conditions
- Psychological Distress
- Being tested
- 10-day meditation intervention, 10-day health education intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10-day meditation interventionBehavioural
prerecorded meditation units delivered by smartphone app
10-day health education interventionBehavioural
prerecorded health education units delivered by smartphone app
| Study group | Role | What they receive |
|---|---|---|
| 10-day meditation intervention | Experimental | prerecorded meditation units, 10 units, one per day, delivered by smartphone app Receives: 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 Receives: Behavioral: 10-day health education intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety features
PROMIS (Patient Reported Outcomes Measurement Information System) Short Form Emotional Distress - Anxiety - 8a
Measured: before, immediately after, 30 days after, and 3 months after the 10-day interventions
Secondary outcomes (1)
depression features
PROMIS Short Form Emotional Distress - Depression - 8a
Measured: before, immediately after, 30 days after, and 3 months after the 10-day interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start3 Dec 2024
- Primary completion19 Sep 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thaddeus Pace, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518616
- Sponsor's protocol ID
- STUDY00003422
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Psychological Distress in Fire Fighters With an Asynchronous App- Based Meditation Intervention
- ClinicalTrials.gov ID
- NCT06518616
- Acronym / sponsor ID
- STUDY00003422
- Conditions
- Psychological Distress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 19 Sep 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 10-day meditation intervention | Experimental | Behavioral: 10-day meditation interventionprerecorded meditation units, 10 units, one per day, delivered by smartphone app |
| 10-day health education intervention | Active comparator | Behavioral: 10-day health education interventionprerecorded health education units, 10 units, one per day, delivered by smartphone app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10-day meditation interventionprerecorded meditation units delivered by smartphone app | Behavioural | 10-day meditation intervention |
| 10-day health education interventionprerecorded health education units delivered by smartphone app | Behavioural | 10-day health education intervention |
Primary outcome
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
1 secondary outcome
depression features
Time frame: before, immediately after, 30 days after, and 3 months after the 10-day interventions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thaddeus Pace, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10-day meditation intervention and 10-day health education intervention in people with Psychological Distress, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety features (time frame: before, immediately after, 30 days after, and 3 months after the 10-day interventions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.