CompletedNot Applicable

Cranial Electrotherapy Stimulation: Piloting a Road to PTSD Prevention in First Responders

United States13 participantsStarted 2024-04-29

Plain-language 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 feelings of depression, 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.

Who can participate

Age range18 Years – 56 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Feasibility of Cranial Electrotherapy Stimulation

Timeframe: During four weeks of cranial electrotherapy stimulation at-home use

Acceptability of Cranial Electrotherapy Stimulation

Timeframe: During four weeks of cranial electrotherapy stimulation

Trial details

NCT IDNCT06203717

SponsorButler Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-03

Results submitted2025-10-14