Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000912684
Ethics application status
Approved
Date submitted
9/08/2023
Date registered
25/08/2023
Date last updated
25/08/2023
Date data sharing statement initially provided
25/08/2023
Date results information initially provided
25/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of Stress Symptoms and Interventions in Firefighters
Scientific title
Efficacy of a Neurofeedback Intervention in Reducing Stress Symptoms in Firefighters
Secondary ID [1] 301263 0
NIL known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 331072 0
Condition category
Condition code
Mental Health 327862 327862 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Neurofeedback training trial to explore efficacy in stress management. Conducted by PhD candidate (psychologist minimum 20 years experience in neurofeedback) in a face-to-face setting in clinical practice. Participants attended between 5-10 training sessions lasting approximately 45minutes duration.
Aims: to explore the efficacy of neurofeedback in assisting with stress management to improve self-reported stress symptoms.
Participants:
Consist of an intervention group who will engage with neurofeedback and a control group that does not have the intervention. Control group participants may cross to the intervention at their request after completing follow up measures.
Procedure:
Consent to participate in an information session.
Information session to ensure prospective participants are fully informed on procedures and conduct of the trial.
Consent to participate in trial.
Baseline self-report questionnaires administered.
Attendance at 6-10 training sessions for stress reduction with attendance occurring weekly. Sessions of training conclude when the participant self reports feeling well on a regular basis and not reporting any further changes and that amplitudes remain consistent at each session. A participant may withdraw from the study at any time.
EEG sensors placed at C3 & C4 as active sites with linked ear references. Ground at hairline of the forehead.
Equipment:
EEGer neurofeedback software (v4.04) manufactured by EEG Spectrum International Inc. Spectrum-2 amplifier manufactured by JJ Engineering, USA.
Participants will be asked to sit relaxed on a chair with back support and watch a screen displaying their brain waves; The system delivers sound feedback (reward) each time the participant’s real-time brain activity at the targeted region meets the desired threshold of increasing the amplitude of 12-15Hz.
Session attendance and verbal feedback from the participant is recorded on a case report form.
Self-report questionnaires are administered at the conclusion of the intervention.
Self-report questionnaires are administered at a minimum of three months follow up.
Intervention code [1] 326737 0
Prevention
Intervention code [2] 326739 0
Behaviour
Comparator / control treatment
Control group: no treatment
Control group
Active

Outcomes
Primary outcome [1] 335705 0
Measuring changes on repeated measures questionnaires noted as primary outcomes:
Post Traumatic Check List (PCL-5)
Timepoint [1] 335705 0
Time 1 Intervention group = pre-intervention neurofeedback
Control group = baseline at completion of consent to participate
Time 2 Intervention group immediately post-intervention of final neurofeedback session
Control group >/= 2 months after baseline
Time 3 Intervention group >/= 3 months after post intervention neurofeedback
Primary outcome [2] 335782 0
Depression subscale of the DASS-21
Timepoint [2] 335782 0
Time 1 Intervention group = pre-intervention neurofeedback
Control group = baseline at completion of consent to participate
Time 2 Intervention group = immediately post-intervention of final neurofeedback session
Control group >/= 2 months after baseline
Time 3 Intervention group >/= 3 months after post intervention neurofeedback
Primary outcome [3] 335783 0
Anxiety subscale of the DASS-21
Timepoint [3] 335783 0
Time 1 Intervention group pre-intervention neurofeedback
Control group baseline at completion of consent to participate
Time 2 Intervention group post-intervention of final neurofeedback session
Control group >/= 2 months after baseline
Time 3 Intervention group >/= 3 months after post intervention neurofeedback
Secondary outcome [1] 425246 0
Stress sub-scale of the DASS-21
This is a primary outcome
Timepoint [1] 425246 0
Time 1 Intervention group pre-intervention neurofeedback
Control group baseline after completion of consent to participate
Time 2 Intervention group post-intervention after final neurofeedback session
Control group >/= 2 months after baseline
Time 3 Intervention group >/= 3 months after post intervention neurofeedback
Secondary outcome [2] 425607 0
Emotional Exhaustion sub-scale of the Maslach Burnout Inventory
This is a primary outcome
Timepoint [2] 425607 0
Time 1 Intervention group pre-intervention neurofeedback
Control group baseline after completion of consent to participate
Time 2 Intervention group post-intervention after final neurofeedback session
Control group >/= 2 months after baseline
Time 3 Intervention group >/= 3 months after post intervention neurofeedback
Secondary outcome [3] 425610 0
Depersonalisation subscale of the Maslach Burnout Inventory
This is a primary outcome
Timepoint [3] 425610 0
Time 1 Intervention group pre-intervention neurofeedback
Control group baseline after completion of consent to participate
Time 2 Intervention group post-intervention after final neurofeedback session
Control group >/= 2 months after baseline
Time 3 Intervention group >/= 3 months after post intervention neurofeedback
Secondary outcome [4] 425611 0
Personal Accomplishment subscale of the Maslach Burnout Inventory
This is a primary outcome
Timepoint [4] 425611 0
Time 1 Intervention group pre-intervention neurofeedback
Control group baseline after completion of consent to participate
Time 2 Intervention group post-intervention after final neurofeedback session
Control group >/= 2 months after baseline
Time 3 Intervention group >/= 3 months after post intervention neurofeedback
Secondary outcome [5] 425612 0
Modified Somatic Perceptions Questionnaire
This is a primary outcome
Timepoint [5] 425612 0
Time 1 Intervention group pre-intervention neurofeedback
Control group baseline after completion of consent to participate
Time 2 Intervention group post-intervention after final neurofeedback session
Control group >/= 2 months after baseline
Time 3 Intervention group >/= 3 months after post intervention neurofeedback
Secondary outcome [6] 425613 0
Pittsburgh Sleep Quality Index
This is a primary outcome
Timepoint [6] 425613 0
Time 1 Intervention group pre-intervention neurofeedback
Control group baseline after completion of consent to participate
Time 2 Intervention group post-intervention after final neurofeedback session
Control group >/= 2 months after baseline
Time 3 Intervention group >/= 3 months after post intervention neurofeedback
Secondary outcome [7] 425614 0
Anger subscale: Buss Perry Aggression Questionnaire
This is a primary outcome
Timepoint [7] 425614 0
Time 1 Intervention group pre-intervention neurofeedback
Control group baseline after consent to participate
Time 2 Intervention group post-intervention after final neurofeedback session
Control group >/= 2 months after baseline
Time 3 Intervention group >/= 3 months after post intervention neurofeedback
Secondary outcome [8] 425615 0
Hostility subscale: Buss Perry Aggression Questionnaire
This is a primary outcome
Timepoint [8] 425615 0
Time 1 Intervention group pre-intervention neurofeedback
Control group baseline after consent to participate
Time 2 Intervention group post-intervention after final neurofeedback session
Control group >/= 2 months after baseline
Time 3 Intervention group >/= 3 months after post intervention neurofeedback
Secondary outcome [9] 425616 0
Verbal aggression subscale: Buss Perry Aggression Questionnaire
This is a primary outcome
Timepoint [9] 425616 0
Time 1 Intervention group pre-intervention neurofeedback
Control group baseline after consent to participate
Time 2 Intervention group post-intervention after final neurofeedback session
Control group >/= 2 months after baseline
Time 3 Intervention group >/= 3 months after post intervention neurofeedback
Secondary outcome [10] 425617 0
Physical aggression subscale: Buss Perry Aggression Questionnaire
This is a primary outcome
Timepoint [10] 425617 0
Time 1 Intervention group pre-intervention neurofeedback
Control group baseline after consent to participate
Time 2 Intervention group post-intervention after final neurofeedback session
Control group >/= 2 months after baseline
Time 3 Intervention group >/= 3 months after post intervention neurofeedback
Secondary outcome [11] 425618 0
Psychological Sense of Organisational Membership
This is a primary outcome
Timepoint [11] 425618 0
Time 1 Intervention group pre-intervention neurofeedback
Control group baseline after consent to participate
Time 2 Intervention group post-intervention after final neurofeedback session
Control group >/= 2 months after baseline
Time 3 Intervention group >/= 3 months after post intervention neurofeedback
Secondary outcome [12] 425619 0
State Trait Anxiety Inventory- State
This is a primary outcome
Timepoint [12] 425619 0
Time 1 Intervention group pre-intervention neurofeedback
Control group baseline after consent to participate
Time 2 Intervention group post-intervention after final neurofeedback session
Control group >/= 2 months after baseline
Time 3 Intervention group >/= 3 months after post intervention neurofeedback
Secondary outcome [13] 425620 0
State Trait Anxiety Inventory- Trait
This is a primary outcome
Timepoint [13] 425620 0
Time 1 Intervention group pre-intervention neurofeedback
Control group baseline after consent to participate
Time 2 Intervention group post-intervention after final neurofeedback session
Control group >/= 2 months after baseline
Time 3 Intervention group >/= 3 months after post intervention neurofeedback

Eligibility
Key inclusion criteria
Operational career Firefighters
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently not working, diagnosed mental health condition, head injury, DSM-5 PTSD diagnosis, unstable medical condition, suicide risk or ideation, history of seizures, and current substance abuse. Unstable medical condition was any medical condition that was in the early stages of investigation or management. For example, an unresolved orthopaedic concern and the use of pain medications; the early stages of controlling blood sugar (pre-diabetic) where stability was still to be assessed or where a condition was not considered stable and well controlled (pre-hypertension). The rationale for this exclusion is that any alterations to mood, energy or fatigue for example may be attributable to the stabilisation of the medical condition rather than the influence of the intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation: Participants self-selected randomly to either treatment or control condition.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study represents a 1 (1*treatment x 3 (time 1, time 2, time 3) and 1*control condition x 2 (time 1, time 2) randomized controlled, with repeated measures. Participants consist of a treatment group and control group (no treatment).
A series of two-way mixed ANOVA were used. That being that firefighters in the experimental group will show improved scores on dependent measures from baseline to Time 2 compared to the control group. The between-subject factors were group (experimental or control) and the within-subject factor will be time (baseline as Time 1 and Time 2). The two-way mixed ANOVA examined main effects for group*time interaction and simple main effects for group. A series of one-way ANOVAs examined the within subjects simple main effects for time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/07/2019
Date of last participant enrolment
Anticipated
Actual
29/11/2021
Date of last data collection
Anticipated
Actual
13/05/2022
Sample size
Target
21
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 305709 0
University
Name [1] 305709 0
Queensland University of Technology
Country [1] 305709 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Faculty of Business & Law
School of Management
Z Block, QUT, Gardens Point
George St
Brisbane, 4000
Queensland
Country
Australia
Secondary sponsor category [1] 306126 0
None
Name [1] 306126 0
Address [1] 306126 0
Country [1] 306126 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305986 0
Queensland University Human Research Ethics Committee
Ethics committee address [1] 305986 0
Human Research Ethics Committee
Queensland University of Technology
Gardens Point
George St Brisbane, 4000
Queensland
Ethics committee country [1] 305986 0
Australia
Date submitted for ethics approval [1] 305986 0
04/04/2019
Approval date [1] 305986 0
01/07/2019
Ethics approval number [1] 305986 0
QUT Ethics Approval Number 1900000154

Summary
Brief summary
Stress is a ubiquitous concern for people however it may be more prevalent in firefighters who routinely face arduous working conditions. Chronic stress has been shown to have detrimental effects on mental health and the ability to self-regulate mood and behaviour. Neurofeedback (NFB) is a brain-computer interface biofeedback intervention.
The objective was to investigate whether NFB could substantially alter self-regulation capacity positively to improve self reported symptoms of stress. There were three hypotheses proposed including, H1: firefighters in the experimental group would show improved scores on self-report measures pre and post intervention. H2: firefighters in the experimental group would maintain these changes at long term follow up. H3: firefighters in the control group would show no change from baseline to follow up.
Neurofeedback training involves watching a computer display to use mental activity to control brain waves of interest. The display and sound changes, in real time, as changes in participants’ brainwaves occurs. The feedback allows for the participants learn to regulate their mental activity. If the mental activity successfully changes the brainwaves in the desired direction to reduce stress and produce calming, participants are rewarded with points. With practice, consistent with how learning occurs participants can improve their response to stress.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102318 0
Ms Tamara Lorensen
Address 102318 0
Faculty of Business & Law
School of Management
Z Block Gardens Point
Queensland University of Technology
George St
Brisbane, 4000
Queensland
Country 102318 0
Australia
Phone 102318 0
+617 31382523
Fax 102318 0
Email 102318 0
[email protected]
Contact person for public queries
Name 102319 0
Tamara Lorensen
Address 102319 0
Faculty of Business & Law
School of Management
Z Block Gardens Point
Queensland University of Technology
George St
Brisbane, 4000
Queensland
Country 102319 0
Australia
Phone 102319 0
+61731382523
Fax 102319 0
Email 102319 0
[email protected]
Contact person for scientific queries
Name 102320 0
Tamara Lorensen
Address 102320 0
Faculty of Business & Law
School of Management
Z Block Gardens Point
Queensland University of Technology
George St
Brisbane, 4000
Queensland
Country 102320 0
Australia
Phone 102320 0
+6173138 2523
Fax 102320 0
Email 102320 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The nature of the data is personal and it is not appropriate for it to be made available to the public. Confidentiality has been assured in the ethics approval.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.