Stress Management Programs in Fire-fighters

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02137941
• Date of registration: 02/05/2014
• Prospective Registration: No
• Primary sponsor: French Defence Health Service
• Public title: Stress Management Programs in Fire-fighters
• Scientific title: Stress Management Programs in Fire-fighters of Paris: a Randomized Controlled Trial
• Date of first enrolment: September 2010
• Target sample size: 180
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02137941
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
• Phase: N/A

Countries of recruitment

France

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Stress

Anxiety

Intervention(s)

Behavioral: techniques to optimize potential (TOP)

Behavioral: heart coherence (HC)

Primary Outcome(s)

Change from Baseline in Perceived stress at the end of the stress managements programs [Time Frame: 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 Outcome(s)

the Spielberger State-Trait-Anxiety Inventory (S-STAI) [Time Frame: 4th month (baseline), 6th month, 12th month, and 18th month]

the profile of mood states (POMS) [Time Frame: 4th month (baseline), 6th month, 12th month, and 18th month]

the Freiburg Mindfulness Inventory-14 [Time Frame: 4th month (baseline), 6th month, 12th month, and 18th month]

heart rate variability [Time Frame: 4th month (baseline), 6th month, 12th month, and 18th month]

salivary cortisol [Time Frame: 4th month (baseline), 6th month, 12th month, and 18th month]

salivary immunoglobulin A [Time Frame: 4th month (baseline), 6th month, 12th month, and 18th month]

urinary catecholamines [Time Frame: 4th month (baseline), 6th month, 12th month, and 18th month]

Secondary ID(s)

n° EudraCT 2010-A00212-37

Source(s) of Monetary Support

Please refer to primary and secondary sponsors