Adults, Firefighters
Conditions
Keywords
Firefighters
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAlpha-Stim AID cranial electrotherapy stimulation
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.
Sponsors
Butler Hospital
University of Rhode Island
Brown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 56 Years
Healthy volunteers
Yes
Inclusion criteria
* Active duty firefighter in Rhode Island, USA; * Age between 18 and 56 years old; * Be in good medical health or, if having chronic medical conditions, these conditions needed to be stable; * Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent.
Exclusion criteria
* MRI and CES-related contraindications, e.g., implanted metallic device or substances including pacemakers, cochlear implant, metallic tattoos, claustrophobia, pregnancy or planning to become pregnant during the study duration and nursing; * Neurological conditions such as brain neoplasm, cerebrovascular events, epilepsy or history of seizures, dementia, and neurodegenerative disorders, or had previously received brain surgery; * Report presence of suicidal ideation on QuickSCID-5 or has attempted suicide one or more times within the past twelve months; * Exhibiting a psychiatric condition that would require inpatient or partial psychiatric hospitalization; * Current moderate or severe alcohol or other substance abuse (excluding nicotine); * Major or unstable medical illness requiring further investigation or treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Cranial Electrotherapy Stimulation | 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). |
| Acceptability of Cranial Electrotherapy Stimulation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Symptoms of Posttraumatic Stress Disorder as Measured With the PTSD Checklist for DMS 5 (PCL-5) | 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. |
| Severity of Symptoms of Depression as Measured With the Inventory of Depressive Symptomatology-Self Report (IDS-SR) | 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. |
| Intensity of Feelings of Fatigue | 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. |
| Intensity of Feelings of Anxiety | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMascha van 't Wout-Frank, PhD
Butler Hospital
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alpha-Stim AID cranial electrotherapy stimulation Four-week course of noninvasive cranial electrotherapy stimulation.
Alpha-Stim AID cranial electrotherapy stimulation: 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. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Alpha-Stim AID cranial electrotherapy stimulation |
|---|---|
| Age, Continuous | 37.15 years STANDARD_DEVIATION 11.07 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Intensity of Feelings of Anxiety | 19.69 VAS Score STANDARD_DEVIATION 24.14 |
| Intensity of Feelings of Fatigue | 34.23 VAS Score STANDARD_DEVIATION 23.93 |
| Inventory of Depressive Symptomatology-Self Report (IDS-SR). | 18.77 Score on IDS-SR STANDARD_DEVIATION 11.35 |
| Posttraumatic Stress Disorder (PTSD) Checklist for DSM-5 | 20.00 Score on PTSD Checklist for DSM-5 STANDARD_DEVIATION 17.29 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 9 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Acceptability 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: During four weeks of cranial electrotherapy stimulation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alpha-Stim AID cranial electrotherapy stimulation | Acceptability of Cranial Electrotherapy Stimulation | 10 Participants |
Primary
Feasibility of Cranial Electrotherapy Stimulation
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 at-home use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alpha-Stim AID cranial electrotherapy stimulation | Feasibility of Cranial Electrotherapy Stimulation | 86.15 percentage of CES sessions completed | Standard Deviation 16.51 |
Secondary
Intensity of Feelings of Anxiety
Intensity of anxiety will be assessed once daily using a visual analog scale (VAS) with a 0 (not at all) - 100 (severe) scale.
Time frame: Daily throughout four weeks of cranial electrotherapy stimulation
Secondary
Intensity of Feelings of Fatigue
Intensity of subjective fatigue assessed once daily using a visual analog scale (VAS) with a 0 (not at all) - 100 (severe) scale.
Time frame: Daily throughout four weeks of cranial electrotherapy stimulation
Secondary
Severity of Symptoms of Depression as Measured With the Inventory of Depressive Symptomatology-Self Report (IDS-SR)
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: post four weeks of cranial electrotherapy stimulation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alpha-Stim AID cranial electrotherapy stimulation | Severity of Symptoms of Depression as Measured With the Inventory of Depressive Symptomatology-Self Report (IDS-SR) | 11.00 score on Inventory of Depressive Symptom | Standard Deviation 7.54 |
p-value: 0.000995% CI: [3.93, 11.61]Paired-sample t-test
Secondary
Severity of Symptoms of Posttraumatic Stress Disorder as Measured With the PTSD Checklist for DMS 5 (PCL-5)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alpha-Stim AID cranial electrotherapy stimulation | Severity of Symptoms of Posttraumatic Stress Disorder as Measured With the PTSD Checklist for DMS 5 (PCL-5) | 10.85 score on PTSD Checklist for DSM-5 | Standard Deviation 10.54 |
p-value: 0.00795% CI: [3.08, 15.23]Paired-sample t-test