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Набор по приглашению NCT07411833

tDCS for Stress and Burnout in Higher Education

Без фазы С лечением Occupational Stress or Workplace Stress Burnout Syndrome Burnout

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct Current Stimulation.
Кому может быть актуально
Состояния в реестре: Occupational Stress or Workplace Stress, Burnout Syndrome, Burnout. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Португалия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Non-Invasive Neuromodulation as a Strategy for Reducing Occupational Stress and Burnout in Higher Education

Обзор

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

Подробное описание

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.

Вмешательства

  • Устройство Transcranial Direct Current Stimulation (tDCS)
    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).
  • Устройство Sham Transcranial Direct Current Stimulation
    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.

Первичные конечные точки

  • Change in Burnout levels measured by the Burnout Assessment Tool (BAT-12) [Срок оценки: 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) [Срок оценки: Baseline (pre-intervention), immediately after intervention completion (approximately 4 weeks), and at 5-week follow-up (approximately 9 weeks from baseline)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

Португалия · 1 центр
  • Egas Moniz School of Health and Science — Almada

Публикации

  • 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. PMID 31663011
  • 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. PMID 34446242
  • 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. PMID 27136575
  • 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. PMID 31340213
  • 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. PMID 28756829
  • 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. PMID 15939546
  • 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. PMID 31560945
  • 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. PMID 26048331

Идентификаторы

NCT: NCT07411833 · PT-194/25

Первоисточники (государственные реестры)

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