Stress Management Programs in Fire-fighters

NCT02137941 | Completed

• 1 other identifier: n° EudraCT 2010-A00212-37
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic stress at work is a public health problem increasing morbidity and mortality, especially in men. Among the men military populations, the firefighters of Paris (FFPs) are particularly exposed. To deal with this stress and to improve stress management is challenging. Psychological fitness is required to regulate emotions which improve effectiveness under stress and enhance recovery from stressful events. The heart coherence (HC) program uses feedback from a simple pulse sensor to reflect changes of the emotional/psychological state, and to learn how to reduce stress and stabilize emotions. Another kind of psychological fitness focuses on cognitive training to regulate emotions, with the use of techniques to optimize potential (TOP). The TOP consists of learning easy techniques in mental skills to improve cognitive-based problem-solving using respiration, relaxation, and visualization. Although never published in a peer-review journal, the procedure of TOP training is structured and standardized for individuals and groups, and is widely practiced in air traffic controllers, with apparently good effects. Moreover, any event can be emotionally ambiguous, providing both negative and positive outcomes. The interpretation of such ambiguity is linked with an individual's emotional state, such as anxiety or mood. Individuals with a high level of trait anxiety are likely to interpret an event negatively. However, no studies have compared the effect of HC or TOP in the perceived stress of FFPs. Nor have long-term effects of these stress management programs (SMP) been investigated. Furthermore, the influence of trait anxiety on stress levels in FFPs needs to be clarified. Finally, no trials have assessed levels of biomarkers stress following these SMP. From these observations, we hypothesized that 1) young recruits aiming to become FFPs will be particularly exposed to stress, 2) SMP will be effective in reducing perceived stress, 3) SMP will mainly benefit FFPs who have high anxiety, and 4) the effects of SMP will lower levels of biomarkers of stress. The aim of this randomized control trial is to evaluate the effectiveness of stress management programs on perceived stress (primary outcome variable), and on negative mood, mindfulness, and biomarkers of stress (secondary outcome variables) in FFPs. We also aim to investigate the influence of anxiety on the stress management programs effectiveness long-term.

Conditions

Stress; Anxiety

Keywords

Stress; occupations; biomarkers; firefighters

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Perceived stress at the end of the stress managements programs

  Perceived stress scale (PSS)

  All baseline assessments (4th month) will be repeated three times: at the end of the stress managements programs (6th month), at the end of the six-month active duty period (12th month) and at 18th month.

Secondary Outcomes (7)

• the profile of mood states (POMS)

  4th month (baseline), 6th month, 12th month, and 18th month

• the Freiburg Mindfulness Inventory-14

  4th month (baseline), 6th month, 12th month, and 18th month

• the Spielberger State-Trait-Anxiety Inventory (S-STAI)

  4th month (baseline), 6th month, 12th month, and 18th month

• heart rate variability

  4th month (baseline), 6th month, 12th month, and 18th month

• salivary cortisol

  4th month (baseline), 6th month, 12th month, and 18th month

Study Arms (3)

techniques to optimize potential (TOP)

ACTIVE COMPARATOR

Behavioral: techniques to optimize potential (TOP)

heart coherence (HC)

ACTIVE COMPARATOR

Behavioral: heart coherence (HC)

controls

PLACEBO COMPARATOR

Interventions

techniques to optimize potential (TOP) BEHAVIORAL

The TOP consists of learning easy techniques in mental skills to improve cognitive-based problem-solving using respiration, relaxation, and visualization.

techniques to optimize potential (TOP)

heart coherence (HC) BEHAVIORAL

The heart coherence (HC) is based on the fact that the heart rhythm becomes more erratic with negative emotions such as anger and anxiety, and more ordered/coherent with sustained positive emotions such as appreciation, love, or compassion, leading to optimal performance and well-being. The HC program uses feedback from a simple pulse sensor to reflect changes of the emotional/psychological state, and to learn how to reduce stress and stabilize emotions.

heart coherence (HC)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• male starting the formation to be a firefighter of Paris

You may not qualify if:

• female
• endocrine disease
• recent extraprofessional life stress event (such as death of a near relative, divorce)
• previous psychological training
• current illness
• medications used to modulate inflammatory diseases (corticosteroids, anti-inflammatory drugs, immunomodulatory drugs)
• medications with a chronotropic effect taken over the previous six months (such as beta blockers, diltiazem, verapamil, anxiolytics or antidepressants)

Sponsors & Collaborators

• French Defence Health Service: lead

Study Sites (1)

Paris Fire Brigade

Paris, Paris, 75000, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: May 14, 2014
• Study Start: September 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

FR (1)