RECRUITING

Novel Mental Health Therapies to Improve Military Readiness

Conditions

Anxiety Alpha Stim Cranial Electrotherapy Stimulation Cognitive Behavioral Therapy Heart Rate Variability

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To evaluate the efficacy of CES as a therapy to treat and mitigate symptoms of generalized anxiety in DoD beneficiaries in a prospective clinical trial and compare this to sham (placebo) CES.

Official Title

Novel Mental Health Therapies to Improve Military Readiness

Quick Facts

Study Start:2024-01-01

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05887713

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Active Duty and DoD Beneficiaries aged 18 or older * Threshold Generalized Anxiety symptoms based on MINI scoring and GAD-7 score of 10 or higher	* Bi-polar disorder, schizophrenia or schizoaffective disorders, manic depressive disorder, autism spectrum disorders, binge eating disorder, anorexia nervosa, bulimia, obsessive compulsive disorder, gender dysphoria (transgender is not an exclusion unless subject meets DSM-5 criteria for gender dysphoria), dementia, mental or other health disorders that prevent subjects from adhering to treatment.This will be verified by patient report or by chart review. * Subjects taking anti-psychotic medications including but not limited to; risperidone, quetiapine, olanzapine, ziprasidone, paliperidone, aripiprazole and clozapine. * Subjects taking any seizure medications (ex: Dilantin) * Subjects who use nicotine in any form: Cigarettes, Vape pens, chewing tobacco, tobacco pouches, patches, gum. * Subjects with medical implant devices such as pacemakers or any device contraindicated for CES treatment. * Subjects who have started, altered, or discontinued use of any anti-depressant or anxiolytic in the past four weeks (including any medication in the following classes; selective serotonin reuptake inhibitors \[SSRI\], serotonin and norepinephrine reuptake inhibitors \[SnRI\], Wellbutrin, beta blockers specifically taken for anxiety, monoamine oxidase inhibitors \[MAOI\], tricyclic antidepressants \[TCA\], benzodiazepenes). * Pregnancy * Current or previous use of a CES device. * Experimental or clinical brain stimulation such as deep brain stimulation or transcranial magnetic stimulation for any indication (current or past 3 months). * Psychotherapy for anxiety based on exposure therapy (current or past 6 weeks) * Seizure disorder (current or history). History of febrile childhood seizures is allowed. * Higher than low suicide risk on the Columbia Suicide Severity Rating Scale (CSSRS). * Known cardiac arrythmias * Anything that would make participation in the study unsafe or medically unadvisable in the assessment of a study clinician.

Inclusion Criteria

Exclusion Criteria

* Active Duty and DoD Beneficiaries aged 18 or older
* Threshold Generalized Anxiety symptoms based on MINI scoring and GAD-7 score of 10 or higher

* Bi-polar disorder, schizophrenia or schizoaffective disorders, manic depressive disorder, autism spectrum disorders, binge eating disorder, anorexia nervosa, bulimia, obsessive compulsive disorder, gender dysphoria (transgender is not an exclusion unless subject meets DSM-5 criteria for gender dysphoria), dementia, mental or other health disorders that prevent subjects from adhering to treatment.This will be verified by patient report or by chart review.
* Subjects taking anti-psychotic medications including but not limited to; risperidone, quetiapine, olanzapine, ziprasidone, paliperidone, aripiprazole and clozapine.
* Subjects taking any seizure medications (ex: Dilantin)
* Subjects who use nicotine in any form: Cigarettes, Vape pens, chewing tobacco, tobacco pouches, patches, gum.
* Subjects with medical implant devices such as pacemakers or any device contraindicated for CES treatment.
* Subjects who have started, altered, or discontinued use of any anti-depressant or anxiolytic in the past four weeks (including any medication in the following classes; selective serotonin reuptake inhibitors \[SSRI\], serotonin and norepinephrine reuptake inhibitors \[SnRI\], Wellbutrin, beta blockers specifically taken for anxiety, monoamine oxidase inhibitors \[MAOI\], tricyclic antidepressants \[TCA\], benzodiazepenes).
* Pregnancy
* Current or previous use of a CES device.
* Experimental or clinical brain stimulation such as deep brain stimulation or transcranial magnetic stimulation for any indication (current or past 3 months).
* Psychotherapy for anxiety based on exposure therapy (current or past 6 weeks)
* Seizure disorder (current or history). History of febrile childhood seizures is allowed.
* Higher than low suicide risk on the Columbia Suicide Severity Rating Scale (CSSRS).
* Known cardiac arrythmias
* Anything that would make participation in the study unsafe or medically unadvisable in the assessment of a study clinician.

Contacts and Locations

Study Contact

Amanda Crawford, MSHS

CONTACT

7026533583

amanda.j.crawford.ctr@health.mil

Study Locations (Sites)

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, 89191

United States

Collaborators and Investigators

Sponsor: David Moss

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-01

Study Completion Date2025-06

Study Record Updates

Study Start Date2024-01-01

Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

Anxiety
Alpha Stim
Cranial Electrotherapy Stimulation
Cognitive Behavioral Therapy
Heart Rate Variability