- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07411833
tDCS for Stress and Burnout in Higher Education (tDCS4HESnB)
Non-Invasive Neuromodulation as a Strategy for Reducing Occupational Stress and Burnout in Higher Education
The goal of this clinical trial is to evaluate if transcranial direct current stimulation (tDCS) works to reduce occupational stress and burnout in university professors. The main questions it aims to answer are:
Does tDCS reduce levels of occupational stress in university professors?
Does tDCS reduce burnout levels in university professors?
Researchers will compare active tDCS to a sham stimulation (a look-alike procedure that contains no active stimulation) and a control group to see if tDCS effectively reduces stress and burnout.
Participants will:
- Complete questionnaires assessing stress and burnout levels before the intervention
- Complete follow-up assessments immediately after the intervention and 5 weeks later
During intervention, participans of active tDCS and Sham gruops will:
- Receive 10 sessions of tDCS over 4 weeks (excluding weekends), 20 minutes each
Study Overview
Status
Detailed Description
Occupational stress, defined as stress in the workplace context, is recognized as one of the main health problems in the work environment. Although having a profession is fundamental for financial support, professional fulfillment and social recognition, factors such as excessive pressure, workload overload and inadequate organizational environment can compromise workers' well-being, making it essential to seek a balance between productivity and health.
Occupational stress has been associated with reduced overall well-being, compromising essential cognitive functions such as concentration and work productivity. Professionals from various areas deal with this problem, particularly those who work directly with people and provide essential services, such as doctors, police officers, firefighters and university professors, being more susceptible to stress.
According to recent studies, university teaching activity has become increasingly demanding, reflected in high levels of work stress. Performance demands, pressure for scientific productivity, overload of administrative and teaching tasks, as well as contractual instability, are factors that contribute to a highly exhausting work environment. These pressures are not just individual perceptions but result from structural conditions present in higher education institutions, with significant impacts on teachers' health, well-being and quality of life.
When occupational stress is not effectively managed, it can become chronic and result in burnout, a disabling condition characterized by a sensation of physical and mental exhaustion, emotional distancing from work accompanied by a negative and cynical attitude towards professional activities, and a reduction in effectiveness and performance in the work environment. In university professors, burnout can reach alarming percentages. Studies reveal that among participants, a significant percentage present critical levels of burnout, requiring immediate intervention. In the national context, although identified burnout levels may not be particularly high, the reduced sample size and unequal distribution of analytical categories may have introduced biases that compromise the robustness of results. Therefore, it becomes evident the need to develop new investigations with larger and more representative samples, as well as using more advanced statistical methods, in order to deepen understanding of burnout in higher education professors and provide more solid bases for creating effective prevention and intervention strategies.
To deal with these problems, various strategies are recommended with relaxation techniques, such as yoga, which have proven effective in reducing occupational stress, especially among health professionals. Mindfulness-based approaches also play an important role in reducing stress and burnout, being widely applied to promote well-being at work. Additionally, music therapy has proven to be an effective complementary strategy in reducing stress, and can be applied in various professions to alleviate negative emotions. Beyond these approaches, new approaches such as non-invasive neuromodulation have shown promise.
Neuromodulation is a growing area that involves various specificities and has a significant impact on hundreds of patients and numerous diseases worldwide. Neuromodulation is a process that aims to modulate cortical excitability and promote synaptic plasticity in regions associated with executive control and the reward system.
Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulation technique that involves applying a continuous low-intensity electrical current directly to the scalp, focusing on the Prefrontal Cortex. It uses conductive materials, sponges and saline solutions to optimize current distribution, and its effects can persist for up to two hours after the session, depending on various factors such as polarity, intensity, duration and personal anatomy.
tDCS alters neuronal activity and promotes brain plasticity, that is, the brain's capacity to reorganize itself and acquire new knowledge. It is a safe approach, without serious or intolerable side effects, which has demonstrated efficacy in various conditions, such as Obsessive-Compulsive Disorder, Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Post-Traumatic Stress Disorder, and Major Depressive Disorder. However, even being a safe technique, tDCS can cause mild and temporary side effects, such as tingling at the electrode site, slight headache, burning sensation on the skin.
Regarding studies with stress and burnout, research suggests that tDCS also plays a significant role in reducing stress and consequently burnout, contributing to an improvement in professional performance and well-being in the work environment. Nevertheless, there is a need for more studies, especially in the context of university teaching, where research remains quite limited. Even after searching various academic databases, no specific articles were found on the use of tDCS in university professors.
Given the need to explore innovative approaches that contribute to mitigating the negative impacts and high occupational stress and burnout in this population, and the potential of tDCS, this dissertation proposes to investigate the effects of neuromodulation as a possible response. The central hypothesis to be tested is: "Neuromodulation will have a significant impact on reducing occupational stress and burnout in Higher Education."
The intervention will consist of ten tDCS sessions, distributed over four weeks (excluding Saturday and Sunday), lasting 20 minutes each. There will be no less than 24 hours between sessions for safety reasons, nor more than 72 hours between sessions to minimize loss of the cumulative effect of tDCS. The intensity of the applied current will be 1.2 mA, with the anode electrode positioned over the left prefrontal cortex (F3 position) and the cathode electrode over the right prefrontal cortex (F4 position). After the intervention, participants complete the post-intervention protocol, which is repeated five weeks later (follow-up). There will also be a control group that will only complete all protocols, without any intervention, with a view to identifying a potential effect of environmental variables on the results.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Setúbal District
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Almada, Setúbal District, Portugal, 2829 - 511
- Egas Moniz School of Health and Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- University staff in active functions
- Age equal to or greater than 18 years
- Availability for the 10 intervention sessions and subsequent assessments
- Voluntary participation with informed consent
Exclusion Criteria:
- Contraindications for tDCS, namely pregnancy, history of seizures or epilepsy, neurological or anatomical contraindications, metal implants or brain surgeries
- Initiation or change in prescription of psychotropic drugs or anticonvulsants in the last 3 months
- Recent active psychotherapy
- Diagnosis of psychiatric condition in the last year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active tDCS
Participants will receive 10 sessions of active transcranial direct current stimulation (tDCS) over 4 weeks (excluding weekends), 20 minutes each session.
The current intensity will be 1.2 mA, with the anode electrode positioned over the left prefrontal cortex (F3 position) and cathode electrode over the right prefrontal cortex (F4 position).
Sessions will be conducted using the PlatoWork tDCS Headset device.
There will be no less than 24 hours and no more than 72 hours between sessions.
|
Active transcranial direct current stimulation will be administered using the PlatoWork tDCS Headset device, developed by PlatoScience, with 20-minute stimulation sessions.
The intervention consists of 10 sessions distributed over 4 weeks, with the anode electrode positioned over the left prefrontal cortex (F3 position) and cathode electrode over the right prefrontal cortex (F4 position).
Other Names:
|
|
Sham Comparator: Sham tDCS
Participants will receive 10 sessions of sham transcranial direct current stimulation over 4 weeks (excluding weekends), 20 minutes each session.
The sham condition will mimic the active tDCS intervention but without delivering therapeutic stimulation.
Sessions will be conducted using the PlatoWork tDCS Headset device configured in sham mode.
There will be no less than 24 hours and no more than 72 hours between sessions.
|
Sham transcranial direct current stimulation will be administered using the PlatoWork tDCS Headset device configured in sham mode.
The sham procedure mimics the active tDCS intervention in all aspects (electrode placement, session duration, device operation) but does not deliver therapeutic stimulation.
This serves as a placebo control to assess the specific effects of active tDCS.
Other Names:
|
|
No Intervention: Control Group
Participants will complete all assessment protocols (pre-intervention, post-intervention, and follow-up) without receiving any intervention.
This group serves to identify potential effects of environmental variables on the results.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Burnout levels measured by the Burnout Assessment Tool (BAT-12)
Time Frame: Baseline (pre-intervention), immediately after intervention completion (approximately 4 weeks), and at 5-week follow-up (approximately 9 weeks from baseline)
|
The BAT-12 assesses burnout in four dimensions (Exhaustion, Mental Distance, Cognitive and Emotional Impairment Control) with 12 items on a 5-point Likert scale (1 = Never; 5 = Always).
Higher scores indicate greater burnout.
The Portuguese version presents good internal consistency with α=0.85.
|
Baseline (pre-intervention), immediately after intervention completion (approximately 4 weeks), and at 5-week follow-up (approximately 9 weeks from baseline)
|
|
Change in Perceived Stress measured by the Perceived Stress Scale (PSS)
Time Frame: Baseline (pre-intervention), immediately after intervention completion (approximately 4 weeks), and at 5-week follow-up (approximately 9 weeks from baseline)
|
The PSS assesses perceived stress in recent weeks.
Contains 10 items on a 5-point Likert scale (0 = Never; 4 = Very frequently).
The Portuguese version presents good internal consistency with α=0.79.
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Baseline (pre-intervention), immediately after intervention completion (approximately 4 weeks), and at 5-week follow-up (approximately 9 weeks from baseline)
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Herrera-Melendez AL, Bajbouj M, Aust S. Application of Transcranial Direct Current Stimulation in Psychiatry. Neuropsychobiology. 2020;79(6):372-383. doi: 10.1159/000501227. Epub 2019 Jul 24.
- Stanton MP, Houser RA, Riechel MEK, Burnham JJ, McDougall G. The Effect of Transcranial Direct Current Stimulation (tDCS) on Resilience, Compassion Fatigue, Stress and Empathy in Professional Nurses. Adv Res. 2015;5(2):10.9734/AIR/2015/16842. doi: 10.9734/AIR/2015/16842. Epub 2015 Jun 8.
- Sudbrack-Oliveira P, Razza LB, Brunoni AR. Non-invasive cortical stimulation: Transcranial direct current stimulation (tDCS). Int Rev Neurobiol. 2021;159:1-22. doi: 10.1016/bs.irn.2021.01.001. Epub 2021 Mar 2.
- Quick JC, Henderson DF. Occupational Stress: Preventing Suffering, Enhancing Wellbeing. Int J Environ Res Public Health. 2016 Apr 29;13(5):459. doi: 10.3390/ijerph13050459.
- Desouky D, Allam H. Occupational stress, anxiety and depression among Egyptian teachers. J Epidemiol Glob Health. 2017 Sep;7(3):191-198. doi: 10.1016/j.jegh.2017.06.002. Epub 2017 Jul 18.
- Brosschot JF, Pieper S, Thayer JF. Expanding stress theory: prolonged activation and perseverative cognition. Psychoneuroendocrinology. 2005 Nov;30(10):1043-9. doi: 10.1016/j.psyneuen.2005.04.008.
- Ahmadizadeh MJ, Rezaei M, Fitzgerald PB. Transcranial direct current stimulation (tDCS) for post-traumatic stress disorder (PTSD): A randomized, double-blinded, controlled trial. Brain Res Bull. 2019 Nov;153:273-278. doi: 10.1016/j.brainresbull.2019.09.011. Epub 2019 Sep 24.
- Acquadro Maran D, Varetto A, Zedda M, Ieraci V. Occupational stress, anxiety and coping strategies in police officers. Occup Med (Lond). 2015 Aug;65(6):466-73. doi: 10.1093/occmed/kqv060. Epub 2015 Jun 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Stress, Psychological
- Occupational Diseases
- Behavior
- Burnout, Psychological
- Occupational Stress
- Therapeutics
- Behavioral Disciplines and Activities
- Electric Stimulation Therapy
- Convulsive Therapy
- Psychiatric Somatic Therapies
- Electroshock
- Psychological Techniques
- Transcranial Direct Current Stimulation
Other Study ID Numbers
- PT-194/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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