NCT Number: NCT07484711
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 opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Coimbra, 3000-115, Portugal
Ana Galhardo, PhD
PRINCIPAL_INVESTIGATOR
Cláudia Ferreira, PhD
PRINCIPAL_INVESTIGATOR
Soraia Moniz
CONTACT
Soraia Moniz, MSc
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline, 8 weeks and 3-month follow-up
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.
Time frame: Baseline, 8 weeks and 3-month follow-up
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.
Time frame: Baseline, 8 weeks and 3-month follow-up
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.
Time frame: Baseline and 8 weeks
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.
Time frame: Baseline, 8 weeks and 3-month follow-up
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.
Time frame: Baseline, 8 weeks and 3-month follow-up
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.
Time frame: Baseline, 8 weeks and 3-month follow-up
Measured with the Psy-Flex. The total score for this scale ranges from 5 to 30, with higher scores indicating greater psychological flexibility.
Time frame: Baseline, 8 weeks and 3-month follow-up
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.
Time frame: 8 weeks
Measured through the feasibility criteria questionnaire (to be developed by the researchers). It will comprise questions addressing overall FIRE satisfaction, perceived usefulness of each session and experiential exercises and willingness to recommend the FIRE to peers.
Time frame: 8 weeks
Measured through the feasibility criteria questionnaire (to be developed by the researchers). This dimension will focus on program adherence (e.g., number of participants, percentage of sessions completed).
Time frame: 8 weeks
Measured through the feasibility criteria questionnaire (to be developed by the researchers). Barriers and facilitators of engagement will be examined.
Time frame: 8 weeks
Measured through the feasibility criteria questionnaire (to be developed by the researchers). This dimension will assess the practicality of delivering the intervention within fire stations, including the availability of required resources (e.g., space, materials).
Time frame: 8 weeks
Measured through the feasibility criteria questionnaire (to be developed by the researchers). This dimension will assess the need for, and type of adaptations required to deliver the intervention in fire stations (e.g., modifications to content, format, duration, or delivery procedures to fit the operational context).
Time frame: 8 weeks
Measured through the feasibility criteria questionnaire (to be developed by the researchers). The integration dimension will be defined as how participant firefighters use the FIRE skills in everyday life and their willingness to continue to do so in the future.
Time frame: 8 weeks
Measured through the feasibility criteria questionnaire (to be developed by the researchers). This dimension will assess the potential for expanding the intervention.
Time frame: 8 weeks
Measured through standardised self-report measures previously mentioned. Limited efficacy will correspond to the effect size estimations of changes in primary and secondary self-reported outcomes in the FIRE Group vs the Wait-list Control Group.
Contact information is provided by the study sponsor or research team.
University of Coimbra
Other
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
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