Health TrialsbyHealthPanel

Effects of Transcranial Electrical Stimulation in Chronic Stress

ConditionsStressSleep
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorEgas Moniz - Cooperativa de Ensino Superior, CRL

About this trial

This clinical trial aims to determine if Transcranial electrical stimulation by direct current (tDCS) and transauricular Vagus Nerve Stimulation (tVNS) treatments are effective in reducing stress symptoms, distress and improving sleep quality in adults. The main questions it aims to answer are:

* Determine if tDCS effectively reduces the intensity of stress symptoms in adults. * Determine if tDCS is effective in reducing levels of distress in adults. * Determine if tDCS is effective in improving sleep quality. * Determine if tVNS is effective in reducing the intensity of stress symptoms in adults. * Determine if tVNS is effective in reducing levels of distress in adults. * Determine if tVNS is effective in improving sleep quality.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

individuals previously diagnosed with stress.

Obtain a score above 4 on the Lipp Adult Stress Symptom Inventory (ISSL);

Must be able to read and understand the purpose of the research and respond to the assessment instruments.

Must acknowledge and agree with the informed consent form.

Disqualifiers

smokers;

be pregnant;

initiation and/or change in psychotropic drug dosage in the last three months;

use of anxiolytics or antidepressants;

Trial design

Design model

Parallel

Treatments tested in this trial

  • tDCS

    Device

    For true tDCS, the technique will be performed with the anode over the right dorsolateral prefrontal cortex and the cathode over the left dorsolateral prefrontal cortex, positioned at F4 and F3, respectively, according to the International 10/20 Electrode Placement System. The current intensity will be set to 2 milliamperes (mA) for 20 minutes over five consecutive days.

  • tVNS

    Device

    For true tVNS stimulation, the technique will be performed with the electrodes positioned on the upper concha of the left ear, using gel for better current distribution.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: tDCS True ModulationExperimental treatment 1 intervention
Group B: tDCS Sham groupSham comparator 1 intervention
Group C: tVNS TrueExperimental treatment 1 intervention
Group D: tVNS ShamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Stress Symptoms assessment

Stress will be assessed using self reported Lipp's Inventory of Stress Symptoms for Adults (LISS). The LISS consists of a questionnaire that assesses physical and psychological symptoms of stress across three time frames: alert (ranging from 0 to 15), resistance (ranging from 0 to 15), quasi-exhaustion or exhaustion (ranging from 0 to 23). Higher scores mean a worse outcome.

Time frame
From enrollment to follow up at 1 month
2

Perceived Stress assessment

Perceived Stress will be assessed using the Perceived Stress Scale (PSS-10). The test ranges from 0 (min) to 40 (max). Higher scores mean a a worst outcome.

Time frame
From enrollment to follow up at 1 month

Secondary outcomes

1

Distress Assessment

Distress will be assessed using the Kessler Psychological Distress Scale (K10). the scale range is from 10 (min) to 50 (max). Higher scores mean a worse outcome.

Time frame
From enrollment to followup at 1 month
2

Sleep Quality

Stress will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global PSQI score ranges from 0 to 21. Higher scores mean a worse outcome

Time frame
From enrollment to follow up at 1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Egas Moniz - Cooperativa de Ensino Superior, CRL

Lead sponsor

Universidade Federal de Alfenas

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: