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Not yet recruiting NCT07484711

F.I.R.E.- Fighters With Focus, Intention, Regulation and Engagement

No phase Interventional Firefighters' Mental Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FIRE.
Who it may be relevant to
Registry conditions: Firefighters' Mental Health. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Behavioral FIRE
    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 ex

Primary outcome measures

  • Well-being [Time frame: Baseline, 8 weeks and 3-month follow-up]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

Inclusion criteria

  • Age 18-65
  • Being a volunteer firefighter

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Portugal · 1 center
  • Faculty of Psychology and Education Sciences, University of Coimbra — Coimbra

Identifiers

NCT: NCT07484711 · FIRE.2024 · 2024.05940.BD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗