- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07484711
F.I.R.E.- Fighters With Focus, Intention, Regulation and Engagement
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Soraia Moniz
- Phone Number: +351912155586
- Email: soraia-moniz@live.com.pt
Study Locations
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-
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Coimbra, Portugal, 3000-115
- Faculty of Psychology and Education Sciences, University of Coimbra
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Contact:
- Soraia Moniz
- Phone Number: +351912155586
- Email: soraia-moniz@live.com.pt
-
Principal Investigator:
- Soraia Moniz, MSc
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Principal Investigator:
- Ana Galhardo, PhD
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Principal Investigator:
- Cláudia Ferreira, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-65
- Being a volunteer firefighter
Exclusion Criteria:
- Currently undergoing any form of psychiatric/psychological intervention (self-reported)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental FIRE Group
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.
|
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.
|
|
No Intervention: Wait-list Control Group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 8 weeks and 3-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
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.
|
Baseline, 8 weeks and 3-month follow-up
|
|
Anxiety
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.
|
Baseline, 8 weeks and 3-month follow-up
|
|
PTSD
Time Frame: Baseline, 8 weeks and 3-month follow-up
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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.
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Baseline, 8 weeks and 3-month follow-up
|
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Attention
Time Frame: Baseline and 8 weeks
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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.
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Baseline and 8 weeks
|
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Mindfulness
Time Frame: Baseline, 8 weeks and 3-month follow-up
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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.
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Baseline, 8 weeks and 3-month follow-up
|
|
Compassion
Time Frame: Baseline, 8 weeks and 3-month follow-up
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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.
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Baseline, 8 weeks and 3-month follow-up
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Psychological Flexibility
Time Frame: Baseline, 8 weeks and 3-month follow-up
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Measured with the Psy-Flex.
The total score for this scale ranges from 5 to 30, with higher scores indicating greater psychological flexibility.
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Baseline, 8 weeks and 3-month follow-up
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Social Safeness
Time Frame: Baseline, 8 weeks and 3-month follow-up
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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.
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Baseline, 8 weeks and 3-month follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility criteria questionnaire - Acceptability
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.
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8 weeks
|
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Feasibility criteria questionnaire - Demand
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).
|
8 weeks
|
|
Feasibility criteria questionnaire - Implementation
Time Frame: 8 weeks
|
Measured through the feasibility criteria questionnaire (to be developed by the researchers).
Barriers and facilitators of engagement will be examined.
|
8 weeks
|
|
Feasibility criteria questionnaire - Practicality
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).
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8 weeks
|
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Feasibility criteria questionnaire - Adaptation
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).
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8 weeks
|
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Feasibility criteria questionnaire - Integration
Time Frame: 8 weeks
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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.
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8 weeks
|
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Feasibility criteria questionnaire - Expansion
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.
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8 weeks
|
|
Limited Efficacy
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.
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8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIRE.2024
- 2024.05940.BD (Other Grant/Funding Number: Foundation for Science and Technology, Portugal)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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