Butler Hospital
Providence, Rhode Island, 02906, United States
NCT Number: NCT06203717
The goal of this study is to test whether active duty firefighters find it possible and suitable to do cranial electrotherapy stimulation (CES) at home, and test whether CES influences measures of depression and posttraumatic stress. The main questions it aims to answer are:
* is CES feasible and acceptable in a population of firefighters, and * does CES changes symptoms of posttraumatic stress and depression as well as feelings of anxiety, and fatigue in firefighters.
Participants will
* complete four weeks of CES at home, and * complete daily assessments of affect and fatigue, and * complete self-reported symptoms of depression and posttraumatic stress before and after four weeks of CES at home Participants maybe asked to * complete an MRI scan before and after four weeks of CES at, and * wear a device to measure their heart rate and sleep quality.
Looking for future studies?
Notify Me18 year–56 year
All sexes
Interventional
Not applicable
Providence, Rhode Island, 02906, United States
Despite an urgent need for interventions that can prevent the development of posttraumatic stress disorder (PTSD) in firefighter first responders who, due to the nature of their occupation, are at ultrahigh risk for PTSD and its profound consequences, current preventative approaches suffer from low rates of efficacy or difficulties with implementation. Cranial electrotherapy stimulation (CES), a noninvasive brain stimulation technique that is FDA approved for treatment of anxiety, insomnia, and depression, offers substantial promise as a proactive preventative intervention for PTSD because of its hypothesized ability to reestablish homeostasis, a process that becomes dysregulated in individuals who develop PTSD. The proposed study is an administrative supplement that combines the unique strengths and knowledge of a complimentary team of scientists from two distinct Centers of Biomedical Research Excellence to test whether four weeks of CES is feasible and acceptable in firefighters as well as obtain early signal of CES efficacy to change subjective and objective indices of homeostatic functioning to allow a long-term collaboration with the ultimate goal to develop a safe, effective, and easily deployable intervention to prevent PTSD in first responders.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cranial electrotherapy stimulation using a modified square, bipolar waveform of 0.5 Hz at 100 μA to be used for four weeks on off-duty days.
Time frame: During four weeks of cranial electrotherapy stimulation at-home use
Feasibility assessed by number of completed cranial electrotherapy stimulation sessions over the course of four weeks (feasible is defined as more than 75% of sessions completed).
Time frame: During four weeks of cranial electrotherapy stimulation
Acceptability assessed by number of individuals who complete at least 75% of all cranial electrotherapy stimulation sessions during four weeks
Time frame: Post four weeks of cranial electrotherapy stimulation
Score on the PTSD Checklist for DSM-5 (PCL-5). Scale ranges from 0 to 80 with higher scores indicating greater severity of posttraumatic stress disorder symptoms.
Time frame: post four weeks of cranial electrotherapy stimulation.
Score on the Inventory of Depressive Symptomatology-Self Report (IDS-SR). The Inventory of Depressive Symptomatology-Self Report (IDS-SR) has a total score range of 0 to 84, with each of its 30 items rated on a scale from 0 to 3. Scores of 18 or above on the IDS-SR indicate the presence of clinically relevant depressive symptomatology.
Time frame: Assessed daily throughout four weeks of cranial electrotherapy stimulation, day 28 reported
Intensity of subjective fatigue assessed once daily using a visual analog scale (VAS) with a 0 (not at all) - 100 (severe) scale.
Time frame: Assessed daily throughout four weeks of cranial electrotherapy stimulation, day 28 reported
Intensity of subjective anxiety assessed once daily using a visual analog scale (VAS) with a 0 (not at all) - 100 (severe) scale.
Butler Hospital
Other
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