According to the proponents of NFT, it has profound effects upon four domains. It is said that NFT reduces stress, improves cognitive functioning, leads to a better overall mood, and ameliorates sleep. Biofeedback has been suggested to improveā¦
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Het heeft geen betrekking op mensen met een aandoening: gezonde militairen (die hun missie hebben kunnen afronden) zijn onze doelgroep
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(see H3 protocol)
Assessment of relaxation level/stress:
Heart rate variability (HRV)
Galvanic Skin Response (GSR)
Respiration
Cortisol level
QEEG
Reaction times and accuracy (Cognitive task N-Back)
Heart rate (variability) during the IAPS pictures task
Subjective Stress level (Perceived Stress Scale and shortened Vas-SACL (last
only in NFT))
Assessment of Self-Efficacy
Coping Self-Efficacy questionnare
Secondary outcome
(see H3 protocol)
Assessment of Fatique
CIS-20 questionnaire
Assessment of Physical Complaints and Anxiety
4DKL questionnaire
Assessment of Sleep
Pittsburgh Sleep Quality Index (PSQI)
Assessment of Depression
The above-mentioned 4DKL will be used to measure symptoms of depression.
Assessment of Burnout
Utrechtse Burnout Scale (UBOS)
Assessment of cognitive functioning in the NFT:
reaction times and accuracy during Mental rotation Task 2D (MRT2D)
reaction times and accuracy during Stroop Color Word Test (SCWT)
Post Deployment Reintegration
Post-Deployment Reintegration Scale (PDRS)
Background summary
Biofeedback training (BFT) aims to train individuals in awareness of and
control over their peripheral stress responses. The underlying philosophy is
that by controlling the primary stress responses to at least some extent, the
impact of stress on performance and quality of life (QoL) may be significantly
reduced. Additionally, specific techniques necessary to obtain this goal may
stimulate relaxation and as such recuperation after stressful events, or
(psychologically) demanding periods.
Neurofeedback training (NFT) represents a sophisticated form of biofeedback
based on specific aspects of cortical activity. It forms part of an operant
conditioning paradigm in which a person can learn how to modify the amplitude
and/or frequency of the electrophysiological aspects of his/her own brain. The
aim of such a technique is to teach the individual what specific states of
cortical arousal feel like and how to activate them voluntarily.
About 1.800 Dutch soldiers were serving in Uruzgan, as part of a NATO
International Security Assis-tance Force (ISAF) operation. As of August 1
(2010), the deployment is scheduled to start a redeployment phase. This implies
that last rotations of military personnel will be active in Uruzgan, preparing
for departure. Deployed military personnel are at risk for development of
posttraumatic stress disorder (PTSD). In recent years the focus has shifted
from studies on core features of PTSD to secondary prevention of stress-related
problems and complaints.
Because deployment to a warzone is associated with chronic hyper arousal in
military persons -in order of COL Vermetten (Military Mental Health, Department
of Defence)- our aim here is to enhance the relaxation level of returning
soldiers and therefore create better functioning in daily life after deployment.
Thus, one aim of this project will be to examine the effect of NFT to enhance
the alpha power incorporating random feedback controls and utilizing a balanced
double blind procedure to explore the beneficial consequences for healthy
military persons returning from Uruzgan.
Increasing peripheral stress management may be another potentially beneficial
approach when aiming at a reduction in post-deployment psychological burden. To
be able to investigate this we propose to use a modified version the
Biofeedback game developed for medical professionals by the Utrecht Medical
Centre.
Study objective
According to the proponents of NFT, it has profound effects upon four domains.
It is said that NFT reduces stress, improves cognitive functioning, leads to a
better overall mood, and ameliorates sleep. Biofeedback has been suggested to
improve stress management skills, general well being and reduce symptoms of
depression and anxiety. We wish to assess the validity of these claims in a
military context, in a scientifically sound way, measuring:
With questionnaires:
Stress level
Self-Efficacy
Fatique
Physical complaints
Anxiety
Sleep
With cognitive tasks:
N-Back
IAPS pictures task
Mental rotation task (NFT only)
Stroop task (NFT only)
With physiological measures:
Brain activity (QEEG)
Respiration
Galvanis skin response
heart rate variability
Cortisol (intake Dexamethason and 3 x saliva extraction)
Study design
This is a balanced and controlled experiment in which hundred sixty (N=160)
soldiers will be assigned to:
1. Audio-based NFT to enhance the alpha power, the feedback is given by
changing the charac-teristic of the subject*s favourite music (N=40)
2. Random beta control group with a randomized frequency conditioning program
(i.e. every ses-sion a different 4 Hz frequency bin between 12 and 20 Hz will
be used), the feedback is given by changing the characteristic of the
subject*s favourite music (N=40)
3. BFT (N=40): an interactive computer game with different events each
controlled by changes in either SCL (skin conductance level) and HRV. It is a
modified version of a medical game currently used by the Patient Safety Centre
of the Utrecht Medical Centre (UMC) for the training of medical professionals.
4. Treatment as usual (TAU) control group (N=40): 30 minutes of non-sports
leisure time (read-ing papers, books, listening to music) every workday for two
weeks.
These are the measurements per period:
Entrance Examination: Sign Informed
Consent
Sign General Information
Balance groups by time period since returning,
deployment experience (in months),
age, and sex
T0 (pre measurement): QEEG, HRV, GSR, Respiration, Cortisol
N-Back task
IAPS pictures task
Post Deployment Reintegration
Stress level, self-efficacy, fatique, physical
complaints, anxiety, sleep
depression, burnout
Instrumental Alpha NFT and Control group:
Conditioning (training): 10x EEG, HRV, GSR, Respiration
Cognitive tasks (Stroop and Mental rotation) and shortened vas-SACL
Biofeedback and Control group:
-
T1 (post measurement): QEEG, HRV, GSR, Respiration, Cortisol
N-Back task
IAPS pictures task
Post Deployment Reintegration
Stress level, self-efficacy, fatique, physical
complaints, anxiety, sleep
depression, burnout
T2 (follow up after three months) QEEG, HRV, GSR, Respiration, Cortisol
N-Back task
IAPS pictures task
Post Deployment Reintegration
Stress level, self-efficacy, fatique, physical
complaints, anxiety, sleep
depression, burnout
Intervention
The intervention will consist of 10 sessions of training.
In the NF- and random beta feedback training (N = 80, total of 45 min), EEG
measurements will take place. In addition to the EEG measurement of the brain
activity at P3-A1 and P4-A2, also heart rate variability, respiration and
galvanic skin response will be captured time synchronously using the NeXus10
Amplifier from TMSi (see Appendix X and Appendix XI for conformity). Between
trainings in one session, cognitive performance will be tested by the Stroop
task and the Mental Rotation Task. A shortened visual analogue SACL is used to
measure relaxation levels between tasks (neurofeedback versus cognitive task).
Next to heart rate variability and galvanic skin response needed for the
biofeedbacktraining (total of 20 min), no variables are measured during the
biofeedback training. The treatment as usual will consist of 30 min relaxation,
without any measuring.
Study burden and risks
Participants will be asked to follow a BFT/NFT program of 2 weeks. The total of
time they are joining our investigation will be 13.5 hours.
No invasive measurements will be done. Participation in the study does not lead
to any direct risks.
Plein 4
postbus 20701, 2500 ES DEN HAAG
NL
Plein 4
postbus 20701, 2500 ES DEN HAAG
NL
Listed location countries
Age
Inclusion criteria
18 * 55 years old healthy soldiers, recently returned from deployment, and written informed consent
Exclusion criteria
Use of psychotropic medication and significant alcohol abuse
(" Because we use soldiers that have finished their deployment, we may assume these persons are fit and healthy, without any mental or medical diagnose" Kol-arts dr. H.G.J.M. Vermetten)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL34819.008.10 |