NCT07484711

Brief 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. 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.

Trial Health

63
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Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

January 19, 2026

Last Update Submit

March 16, 2026

Conditions

Keywords

Psychological InterventionFirefightersAcceptance and Commitment TherapyCompassionFeasibility studyMindfulness

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 8 weeks and 3-month follow-up

Secondary Outcomes (8)

  • Depression

    Baseline, 8 weeks and 3-month follow-up

  • Anxiety

    Baseline, 8 weeks and 3-month follow-up

  • PTSD

    Baseline, 8 weeks and 3-month follow-up

  • Attention

    Baseline and 8 weeks

  • Mindfulness

    Baseline, 8 weeks and 3-month follow-up

  • +3 more secondary outcomes

Other Outcomes (8)

  • Feasibility criteria questionnaire - Acceptability

    8 weeks

  • Feasibility criteria questionnaire - Demand

    8 weeks

  • Feasibility criteria questionnaire - Implementation

    8 weeks

  • +5 more other outcomes

Study Arms (2)

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.

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.

Interventions

FIREBEHAVIORAL

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.

Experimental FIRE Group

Eligibility Criteria

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

You may qualify if:

  • Age 18-65
  • Being a volunteer firefighter

You may not qualify if:

  • Currently undergoing any form of psychiatric/psychological intervention (self-reported)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Psychology and Education Sciences, University of Coimbra

Coimbra, 3000-115, Portugal

Location

MeSH Terms

Interventions

Fires

Intervention Hierarchy (Ancestors)

EnvironmentEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2026

First Posted

March 20, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations