Firefighters' Mental HealthNCT07484711
F.I.R.E.- Fighters With Focus, Intention, Regulation and Engagement
A study testing FIRE in people with Firefighters' Mental Health, run by University of Coimbra at 1 site in Portugal.
Trial summary
Firefighters are routinely exposed to potentially traumatic events, making them vulnerable to debilitating mental health problems. Consequently, promoting well-being and the ability to respond effectively and safely to work demands are vital. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Firefighters' Mental Health
- What is being tested?
- FIRE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 sitePortugal
- Study dates
- Aug 2026to May 2028
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- Being a volunteer firefighter
Who cannot join
- Currently undergoing any form of psychiatric/psychological intervention (self-reported)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Faculty of Psychology and Education Sciences, University of Coimbra
Coimbra, 3000-115
Soraia Moniz, +351912155586, soraia-moniz@live.com.pt
Soraia Moniz, MSc
About this study
Official title: F.I.R.E.- Fighters With Focus, Intention, Regulation and Engagement: Development and Feasibility Study of a Psychological Intervention Aiming to Promote Firefighters' Well-being and Mental Health
Firefighters are routinely exposed to potentially traumatic events, making them vulnerable to debilitating mental health problems. Consequently, promoting well-being and the ability to respond effectively and safely to work demands are vital. The FIRE is an innovative mindfulness, Acceptance and Commitment Therapy, and compassion-based manualized intervention encompassing eight weekly group sessions delivered at Fire Stations. A preliminary version of this program will be refined based on qualitative inputs from structured interviews with firefighters and emergency/civil protection sector stakeholders. The FIRE feasibility dimensions of adaptation, acceptability, implementation, practicality, integration, and limited efficacy will be evaluated in a two-arm, 1:1, non-blinded randomised controlled trial. The extent to which the FIRE contributes to the promotion of well-being and the decrease of psychopathological symptoms, and the causal theory underlying FIRE, will be explored through an examination of potential mechanisms of change.
Read the detailed description
The FIRE is an innovative mindfulness, Acceptance and Commitment Therapy, and compassion-based manualised intervention, encompassing 8-weekly group sessions delivered at Fire Stations. The FIRE implementation will occur outside the Charlie phase (fire critical season, from May to October), controlling for the potential seasonality impact on results. Two clinical psychologists with mindfulness, ACT, and compassion training will facilitate the FIRE sessions. Weekly gentle reminders will be sent to motivate participants to practice the between-sessions exercises.
The current project aims to conduct a feasibility study, including the dimensions of adaptation, acceptability, implementation, practicality, integration, and limited efficacy. Regarding limited efficacy, it is hypothesised that participants in the experimental group (EG-FIRE) will reveal significant decreases in firefighters' psychopathological symptoms (depression, anxiety, PTSD) and will present higher levels of well-being, feelings of belonging, acceptance, and feelings of warmth from colleagues, and attention when compared to participants in the waiting-list control group (CG-WL). It is also hypothesised that these improvements will persist over a 3-month follow-up period.
The ANEPC will invite Fire Stations in the centre region of Portugal to participate. The FIRE will be presented at each Fire Station enrolled in the study during an informative session, and a leaflet will also be distributed. Interested firefighters will be asked to register, assess eligibility, and give informed consent. Consenting participants will be randomly allocated to: a) experimental group-EG-FIRE receiving the intervention; b) wait-list control group-WL-CG.
All ethical requirements for research with humans will be guaranteed. Participants will complete online standardised self-report measures at pre-intervention (M0), post-intervention (M1), and 3-month follow-up (M2). At M1, the EG-FIRE will complete a feasibility criteria questionnaire. Limited efficacy will be assessed using Intention-to-Treat and per-protocol analyses. Two-way mixed ANOVAs and MANOVAs will be computed on the study outcomes, with Group (EG-FIRE, WL-CG) as the between-subject variable and Time (M0, M1) as the within-subject factor. Repeated ANOVAs and MANOVAS with Time (M1, M2) as the within-subject factor will be computed to investigate changes in outcomes from M1 to M2 and at the 3-month follow-up in the EG-FIRE. Effect sizes will be analysed.
To limit attrition rates, risks, and barriers to the FIRE implementation (interference with firefighters' assignments), it will be proposed that sessions be scheduled to avoid conflicts with participants' work shifts, held at the Fire Station (to avoid participants' burden). It will be negotiated to include the FIRE sessions in the national training hours plan for EG-FIRE participants. To ensure the program's rigorous implementation, weekly meetings will be held with the project supervisors.
The FIRE is expected to be a feasible program that will advance, disseminate, and facilitate knowledge transfer, providing scientific evidence to inform mental health practices for the emergency and civil protection sectors. It is expected to promote well-being, feelings of connectedness, belonging, warmth, acceptance, and attention, and decrease firefighters' psychopathological symptoms. Mental health benefits are expected to result from improvements in mindfulness, psychological flexibility, and compassion skills, and from decreases in rumination, and to be sustained over a 3-month follow-up. Two self-report measures adapted to the firefighters' setting will be available, contributing to further investigate psychological aspects in this population.
- Conditions
- Firefighters' Mental Health
- Being tested
- FIRE
- Keywords
- Psychological Intervention, Firefighters, Acceptance and Commitment Therapy, Compassion, Feasibility study, Mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIREBehavioural
The FIRE will include 8-weekly group sessions (10-15 participants per group; 90-minutes duration) delivered at Fire Stations. The FIRE implementation will occur outside the charlie phase (fire critical season, from May to October), controlling for the potential seasonality impact on results. Two clinical psychologists with mindfulness, ACT and compassion training will facilitate the FIRE sessions. Weekly gentle reminders will be sent to motivating participants to practice the between-sessions exercises.
| Study group | Role | What they receive |
|---|---|---|
| Experimental FIRE Group | Experimental | Participants in the experimental group will receive the FIRE programme delivered at Fire Stations. Participants will complete online standardised self-report measures, pre-(M0), post-intervention (M1) and 3-months follow-up (M2). At M1, the experimental FIRE group will complete a feasibility criteria questionnaire. Receives: Behavioral: FIRE |
| Wait-list Control Group | No intervention | Participants in the wait-list control group will complete online standardised self-report measures, pre-(M0), post-intervention (M1) and 3-months follow-up (M2). The wait-list control group participants will be offered the opportunity to receive the FIRE programme after the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Well-being
Measured by the World Health Organization Well-Being Index 5 (WHO-5). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Measured: Baseline, 8 weeks and 3-month follow-up
Secondary outcomes (8)
Depression
Measured with the depression subscale of the Patient Health Questionnaire 4 (PHQ-4). The subscale scores range between 0 and 6. Scores equal or higher than 3 are a reasonable cut-off point for detecting possible cases of depression.
Measured: Baseline, 8 weeks and 3-month follow-up
Anxiety
Measured with the anxiety subscale of the Patient Health Questionnaire-4 (PHQ-4). The subscale scores range between 0 and 6. Scores equal to or higher than 3 are a reasonable cut-off point for detecting possible cases of anxiety.
Measured: Baseline, 8 weeks and 3-month follow-up
PTSD
Measured with the PTSD Checklist-5. The total score ranges from 0 to 80, with higher scores indicating greater severity of post-traumatic stress disorder symptoms.
Measured: Baseline, 8 weeks and 3-month follow-up
Attention
Measured with the Toulose Piéron Cancellation Test. Performance is assessed based on the number of correctly cancelled stimuli, errors of omission and commission, and indices of attention and concentration, with higher scores indicating better attentional performance.
Measured: Baseline and 8 weeks
Mindfulness
Measured with the Five-Facet Mindfulness Questionnaire (FFMQ; 18-item version). The total score for this scale ranges from 18 to 90, with higher scores indicating greater mindfulness skills.
Measured: Baseline, 8 weeks and 3-month follow-up
Compassion
Measured with the Self-Compassion Scale - short form (SCS-SF). The total score for this scale ranges from 12 to 60, with higher scores indicating greater self-compassion.
Measured: Baseline, 8 weeks and 3-month follow-up
Psychological Flexibility
Measured with the Psy-Flex. The total score for this scale ranges from 5 to 30, with higher scores indicating greater psychological flexibility.
Measured: Baseline, 8 weeks and 3-month follow-up
Social Safeness
Measured with the Social Safeness and Pleasure Scale - Firefighters (SSPS-F). The total score ranges from 11 to 55, with higher scores indicating greater perceived social safeness and pleasure.
Measured: Baseline, 8 weeks and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study startAug 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Firefighters' Mental HealthStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Fire Stations in the centre region of Portugal will be invited to participate by the National Emergency and Civil Protection Authority (ANEPC). Consenting Fire Stations will be randomly allocated (www.random.org) to: a) experimental group-EG-FIRE receiving the intervention; b) wait-list control group-WL-CG. FIRE will be presented to the EG-FIRE fire stations participating in the study at an information event, and a brochure will also be distributed. Interested firefighters will be asked to register, assess eligibility, and provide informed consent.
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soraia Moniz, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484711
- Sponsor's protocol ID
- FIRE.2024
- Other IDs
- 2024.05940.BD
- Status last verified
- Mar 2026
- First submitted
- 19 Jan 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F.I.R.E.- Fighters With Focus, Intention, Regulation and Engagement: Development and Feasibility Study of a Psychological Intervention Aiming to Promote Firefighters' Well-being and Mental Health
- ClinicalTrials.gov ID
- NCT07484711
- Acronym / sponsor ID
- FIRE.2024
- Conditions
- Firefighters' Mental Health
- Keywords
- Psychological Intervention, Firefighters, Acceptance and Commitment Therapy, Compassion, Feasibility study, Mindfulness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 20 Mar 2026 (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.
Firefighters are routinely exposed to potentially traumatic events, making them vulnerable to debilitating mental health problems. Consequently, promoting well-being and the ability to respond effectively and safely to work demands are vital. The FIRE is an innovative mindfulness, Acceptance and Commitment Therapy, and compassion-based manualized intervention encompassing eight weekly group sessions delivered at Fire Stations. A preliminary version of this program will be refined based on qualitative inputs from structured interviews with firefighters and emergency/civil protection sector stakeholders. The FIRE feasibility dimensions of adaptation, acceptability, implementation, practicality, integration, and limited efficacy will be evaluated in a two-arm, 1:1, non-blinded randomised controlled trial. The extent to which the FIRE contributes to the promotion of well-being and the decrease of psychopathological symptoms, and the causal theory underlying FIRE, will be explored through an examination of potential mechanisms of change.
Detailed description
The FIRE is an innovative mindfulness, Acceptance and Commitment Therapy, and compassion-based manualised intervention, encompassing 8-weekly group sessions delivered at Fire Stations. The FIRE implementation will occur outside the Charlie phase (fire critical season, from May to October), controlling for the potential seasonality impact on results. Two clinical psychologists with mindfulness, ACT, and compassion training will facilitate the FIRE sessions. Weekly gentle reminders will be sent to motivate participants to practice the between-sessions exercises.
The current project aims to conduct a feasibility study, including the dimensions of adaptation, acceptability, implementation, practicality, integration, and limited efficacy. Regarding limited efficacy, it is hypothesised that participants in the experimental group (EG-FIRE) will reveal significant decreases in firefighters' psychopathological symptoms (depression, anxiety, PTSD) and will present higher levels of well-being, feelings of belonging, acceptance, and feelings of warmth from colleagues, and attention when compared to participants in the waiting-list control group (CG-WL). It is also hypothesised that these improvements will persist over a 3-month follow-up period.
The ANEPC will invite Fire Stations in the centre region of Portugal to participate. The FIRE will be presented at each Fire Station enrolled in the study during an informative session, and a leaflet will also be distributed. Interested firefighters will be asked to register, assess eligibility, and give informed consent. Consenting participants will be randomly allocated to: a) experimental group-EG-FIRE receiving the intervention; b) wait-list control group-WL-CG.
All ethical requirements for research with humans will be guaranteed. Participants will complete online standardised self-report measures at pre-intervention (M0), post-intervention (M1), and 3-month follow-up (M2). At M1, the EG-FIRE will complete a feasibility criteria questionnaire. Limited efficacy will be assessed using Intention-to-Treat and per-protocol analyses. Two-way mixed ANOVAs and MANOVAs will be computed on the study outcomes, with Group (EG-FIRE, WL-CG) as the between-subject variable and Time (M0, M1) as the within-subject factor. Repeated ANOVAs and MANOVAS with Time (M1, M2) as the within-subject factor will be computed to investigate changes in outcomes from M1 to M2 and at the 3-month follow-up in the EG-FIRE. Effect sizes will be analysed.
To limit attrition rates, risks, and barriers to the FIRE implementation (interference with firefighters' assignments), it will be proposed that sessions be scheduled to avoid conflicts with participants' work shifts, held at the Fire Station (to avoid participants' burden). It will be negotiated to include the FIRE sessions in the national training hours plan for EG-FIRE participants. To ensure the program's rigorous implementation, weekly meetings will be held with the project supervisors.
The FIRE is expected to be a feasible program that will advance, disseminate, and facilitate knowledge transfer, providing scientific evidence to inform mental health practices for the emergency and civil protection sectors. It is expected to promote well-being, feelings of connectedness, belonging, warmth, acceptance, and attention, and decrease firefighters' psychopathological symptoms. Mental health benefits are expected to result from improvements in mindfulness, psychological flexibility, and compassion skills, and from decreases in rumination, and to be sustained over a 3-month follow-up. Two self-report measures adapted to the firefighters' setting will be available, contributing to further investigate psychological aspects in this population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Fire Stations in the centre region of Portugal will be invited to participate by the National Emergency and Civil Protection Authority (ANEPC). Consenting Fire Stations will be randomly allocated (www.random.org) to: a) experimental group-EG-FIRE receiving the intervention; b) wait-list control group-WL-CG. FIRE will be presented to the EG-FIRE fire stations participating in the study at an information event, and a brochure will also be distributed. Interested firefighters will be asked to register, assess eligibility, and provide informed consent.
| Arm | Type | Receives |
|---|---|---|
| Experimental FIRE Group | Experimental | Behavioral: FIREParticipants in the experimental group will receive the FIRE programme delivered at Fire Stations. Participants will complete online standardised self-report measures, pre-(M0), post-intervention (M1) and 3-months follow-up (M2). At M1, the experimental FIRE group will complete a feasibility criteria questionnaire. |
| Wait-list Control Group | No intervention | –Participants in the wait-list control group will complete online standardised self-report measures, pre-(M0), post-intervention (M1) and 3-months follow-up (M2). The wait-list control group participants will be offered the opportunity to receive the FIRE programme after the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-65
- Being a volunteer firefighter
Key exclusion criteria (1 listed)
- Currently undergoing any form of psychiatric/psychological intervention (self-reported)
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 |
|---|---|---|
| FIREThe FIRE will include 8-weekly group sessions (10-15 participants per group; 90-minutes duration) delivered at Fire Stations. The FIRE implementation will occur outside the charlie phase (fire critical season, from May to October), controlling for the potential seasonality impact on results. Two clinical psychologists with mindfulness, ACT and compassion training will facilitate the FIRE sessions. Weekly gentle reminders will be sent to motivating participants to practice the between-sessions exercises. | Behavioural | Experimental FIRE Group |
Primary outcome
Well-being
Time frame: Baseline, 8 weeks and 3-month follow-up
Measured by the World Health Organization Well-Being Index 5 (WHO-5). The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
8 secondary outcomes
Depression
Time frame: Baseline, 8 weeks and 3-month follow-up
Anxiety
Time frame: Baseline, 8 weeks and 3-month follow-up
PTSD
Time frame: Baseline, 8 weeks and 3-month follow-up
Attention
Time frame: Baseline and 8 weeks
Mindfulness
Time frame: Baseline, 8 weeks and 3-month follow-up
Compassion
Time frame: Baseline, 8 weeks and 3-month follow-up
Psychological Flexibility
Time frame: Baseline, 8 weeks and 3-month follow-up
Social Safeness
Time frame: Baseline, 8 weeks and 3-month follow-up
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 20 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIRE in people with Firefighters' Mental Health, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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: opening soon, as of the sponsor's last update on 20 Mar 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 Portugal. 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.
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?
Contact Soraia Moniz (+351912155586, soraia-moniz@live.com.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Well-being (time frame: Baseline, 8 weeks and 3-month follow-up). 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 20 Mar 2026.