StressNCT02137941
Stress Management Programs in Fire-fighters
A study testing techniques to optimize potential (TOP) and heart coherence (HC) in people with Stress and Anxiety, run by French Defence Health Service at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- What is being tested?
- techniques to optimize potential (TOP) and heart coherence (HC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male starting the formation to be a firefighter of Paris
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress Management Programs in Fire-fighters of Paris: a Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
The army's FFPs unit recruits new FFPs each month who received a twelve-month contract comprising of a six-month induction program (1st month to 6th month) and a six-month active duty period (6th month to 12th month). Within our study, volunteers will be included at the 4th month (baseline measurements after the first four months of training), in order to avoid the high drop-out rate that occurs during the beginning of this period. Included participants will be randomly assigned (computer-generated randomization) to one of the three following groups: TOP, HC, or control, and the stress managements programs will occur during the last two months of induction program (4th month to 6th month). The two stress managements programs will be taught by an experimented psychologist, with daily requirements of short practice tasks. All three groups will receive a pharmaceutical placebo in order to control any placebo effect. The placebo will comprise of starch concealed in a capsule, and was required to be consumed between the 4th month and the 6th month.
The primary outcome will be perceived stress. Secondary outcomes will be changes in mood, mindfulness and biomarkers of stress.
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 the 18th month.
Enrolment will set to end when 180 FFPs (60 per group) will be included. We estimated that with 55 participants in each group, the study would have more than 80% power to detect a clinically important difference among the groups in the change of perceived stress, at an alpha level of 5%.
Gaussian distribution of the data wil be tested by the Kolmogorov-Smirnov test. Data will be presented as mean ± standard deviation (SD). Comparisons between groups will be made with Wilcoxon matched-pairs test or ANOVA when appropriate. Relationships between data will be assessed by Pearson correlation, a Principal Components Analysis or a multivariable generalized estimating equations model when appropriate. Significance will be accepted at the p<0.05 level. Statistical procedures will be performed using SPSS Advanced Statistics software (SPSS Inc., Chicago, IL).
- Being tested
- techniques to optimize potential (TOP), heart coherence (HC)
- Keywords
- Stress, occupations, biomarkers, firefighters
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
techniques to optimize potential (TOP)Behavioural
The TOP consists of learning easy techniques in mental skills to improve cognitive-based problem-solving using respiration, relaxation, and visualization.
heart coherence (HC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| techniques to optimize potential (TOP) | Active comparator | Not described Receives: Behavioral: techniques to optimize potential (TOP) |
| heart coherence (HC) | Active comparator | Not described Receives: Behavioral: heart coherence (HC) |
| controls | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Perceived stress at the end of the stress managements programs
Perceived stress scale (PSS)
Measured: 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)
Measured: 4th month (baseline), 6th month, 12th month, and 18th month
the Freiburg Mindfulness Inventory-14
Measured: 4th month (baseline), 6th month, 12th month, and 18th month
the Spielberger State-Trait-Anxiety Inventory (S-STAI)
Measured: 4th month (baseline), 6th month, 12th month, and 18th month
heart rate variability
Measured: 4th month (baseline), 6th month, 12th month, and 18th month
salivary cortisol
Measured: 4th month (baseline), 6th month, 12th month, and 18th month
salivary immunoglobulin A
Measured: 4th month (baseline), 6th month, 12th month, and 18th month
urinary catecholamines
Measured: 4th month (baseline), 6th month, 12th month, and 18th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startSep 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Defence Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Frédéric Dutheil, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137941
- Sponsor's protocol ID
- n° EudraCT 2010-A00212-37
- Status last verified
- May 2014
- First submitted
- 2 May 2014
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Management Programs in Fire-fighters of Paris: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02137941
- Acronym / sponsor ID
- n° EudraCT 2010-A00212-37
- Keywords
- Stress, occupations, biomarkers, firefighters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- French Defence Health ServiceOther government
- Study start
- Sep 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The army's FFPs unit recruits new FFPs each month who received a twelve-month contract comprising of a six-month induction program (1st month to 6th month) and a six-month active duty period (6th month to 12th month). Within our study, volunteers will be included at the 4th month (baseline measurements after the first four months of training), in order to avoid the high drop-out rate that occurs during the beginning of this period. Included participants will be randomly assigned (computer-generated randomization) to one of the three following groups: TOP, HC, or control, and the stress managements programs will occur during the last two months of induction program (4th month to 6th month). The two stress managements programs will be taught by an experimented psychologist, with daily requirements of short practice tasks. All three groups will receive a pharmaceutical placebo in order to control any placebo effect. The placebo will comprise of starch concealed in a capsule, and was required to be consumed between the 4th month and the 6th month.
The primary outcome will be perceived stress. Secondary outcomes will be changes in mood, mindfulness and biomarkers of stress.
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 the 18th month.
Enrolment will set to end when 180 FFPs (60 per group) will be included. We estimated that with 55 participants in each group, the study would have more than 80% power to detect a clinically important difference among the groups in the change of perceived stress, at an alpha level of 5%.
Gaussian distribution of the data wil be tested by the Kolmogorov-Smirnov test. Data will be presented as mean ± standard deviation (SD). Comparisons between groups will be made with Wilcoxon matched-pairs test or ANOVA when appropriate. Relationships between data will be assessed by Pearson correlation, a Principal Components Analysis or a multivariable generalized estimating equations model when appropriate. Significance will be accepted at the p<0.05 level. Statistical procedures will be performed using SPSS Advanced Statistics software (SPSS Inc., Chicago, IL).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- male starting the formation to be a firefighter of Paris
Key exclusion criteria (7 listed)
- female
- endocrine disease
- recent extraprofessional life stress event (such as death of a near relative, divorce)
- previous psychological training
- current illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | techniques to optimize potential (TOP) |
| heart coherence (HC)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. | Behavioural | heart coherence (HC) |
Primary outcome
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.
Perceived stress scale (PSS)
7 secondary outcomes
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
the Spielberger State-Trait-Anxiety Inventory (S-STAI)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing techniques to optimize potential (TOP) and heart coherence (HC) in people with Stress and Anxiety, run by French Defence Health Service at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.