Anxiety Clinical Trial
Official title:
Stress Management Programs in Fire-fighters of Paris: a Randomized Controlled Trial
Verified date | May 2014 |
Source | French Defence Health Service |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 180 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - male starting the formation to be a firefighter of Paris Exclusion Criteria: - 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) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Country | Name | City | State |
---|---|---|---|
France | Paris Fire Brigade | Paris |
Lead Sponsor | Collaborator |
---|---|
French Defence Health Service |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
Secondary | the profile of mood states (POMS) | 4th month (baseline), 6th month, 12th month, and 18th month | No | |
Secondary | the Freiburg Mindfulness Inventory-14 | 4th month (baseline), 6th month, 12th month, and 18th month | No | |
Secondary | the Spielberger State-Trait-Anxiety Inventory (S-STAI) | 4th month (baseline), 6th month, 12th month, and 18th month | No | |
Secondary | heart rate variability | 4th month (baseline), 6th month, 12th month, and 18th month | No | |
Secondary | salivary cortisol | 4th month (baseline), 6th month, 12th month, and 18th month | No | |
Secondary | salivary immunoglobulin A | 4th month (baseline), 6th month, 12th month, and 18th month | No | |
Secondary | urinary catecholamines | 4th month (baseline), 6th month, 12th month, and 18th month | No |
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