ACTIVE_NOT_RECRUITING

CES for the Treatment of GAD in Young Adults

Conditions

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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

The purpose of this research study is to study cranial electrotherapy stimulation (CES) to determine its effects on symptoms of anxiety in people with generalized anxiety disorder (GAD) between the ages of 18 - 21 years of age.

Official Title

Cranial Electrotherapy Stimulation (CES) for the Treatment of Generalized Anxiety Disorder (GAD) in Young Adults: Double-Blind Sham-Controlled Randomized Clinical Trial

Quick Facts

Study Start:2024-01-26

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06124014

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 to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Capable of signing informed consent form. * Stated willingness to comply with all study procedures and availability for the duration of the study including refraining from changes to treatment unless medically indicated and communicated to the study team. * Aged 18 - 21 at time of screening visit. * Diagnosis of generalized anxiety disorder (GAD). * At least mild-to-moderate symptom severity, as indicated by scores of 15 or higher on the clinician-administered HAM-A at the screening visit. * Concurrent psychiatric medications are allowed. Participants will be required to maintain a sable dose of medications, or remain medication free, for 2 weeks prior to the screening visit, except for antidepressants for which the period of stable dose is 4 weeks prior to screening visit. Concurrent psychotherapy is allowed. * People of reproductive potential must be willing to use effective contraception (evidence-based hormonal or barrier methods) for at least 1 month prior to the screening visit and agree to use such a method during study participation.	* Current (any) or previous (\> 7 stimulation sessions in last 6 weeks) use of a CES device. * Inability to tolerate the required minimum stimulation amplitude (200 uA) during the initial device training at the baseline visit. * Experimental or clinical brain stimulation such as deep brain stimulation or transcranial magnetic stimulation for any indication (current or within 60 days prior to screening visit). * Implanted medical device that uses electricity anywhere in the body. * Diagnosis (based on MINI) of bipolar I or II (past or current), moderate or severe alcohol use disorder (within 12 months prior to screening visit), moderate or severe (non-alcohol) substance use disorder (within 12 months prior to screening visit), psychotic disorder (current or lifetime), major depressive disorder with psychotic features, bipolar I with psychotic features, anorexia nervosa. * Epilepsy (current or history). History of febrile childhood seizures and non-epileptic seizures are allowed. * Pregnant or breast-feeding. * Enrollment in clinical trial for any condition (current or within 60 days prior to screening visit). * Hospitalization for any reason (current or past 2 weeks). * Self-harming behaviors (current or within two years prior to screening visit). * Higher than low suicide risk on the Columbia Suicide Severity Rating Scale (C-SSRS). * Known cardiac abnormality or clinically significant heart disease. * Anything that would make participation in the study unsafe or medically unadvisable in the assessment of a study clinician.

Inclusion Criteria

Exclusion Criteria

* Capable of signing informed consent form.
* Stated willingness to comply with all study procedures and availability for the duration of the study including refraining from changes to treatment unless medically indicated and communicated to the study team.
* Aged 18 - 21 at time of screening visit.
* Diagnosis of generalized anxiety disorder (GAD).
* At least mild-to-moderate symptom severity, as indicated by scores of 15 or higher on the clinician-administered HAM-A at the screening visit.
* Concurrent psychiatric medications are allowed. Participants will be required to maintain a sable dose of medications, or remain medication free, for 2 weeks prior to the screening visit, except for antidepressants for which the period of stable dose is 4 weeks prior to screening visit. Concurrent psychotherapy is allowed.
* People of reproductive potential must be willing to use effective contraception (evidence-based hormonal or barrier methods) for at least 1 month prior to the screening visit and agree to use such a method during study participation.

* Current (any) or previous (\> 7 stimulation sessions in last 6 weeks) use of a CES device.
* Inability to tolerate the required minimum stimulation amplitude (200 uA) during the initial device training at the baseline visit.
* Experimental or clinical brain stimulation such as deep brain stimulation or transcranial magnetic stimulation for any indication (current or within 60 days prior to screening visit).
* Implanted medical device that uses electricity anywhere in the body.
* Diagnosis (based on MINI) of bipolar I or II (past or current), moderate or severe alcohol use disorder (within 12 months prior to screening visit), moderate or severe (non-alcohol) substance use disorder (within 12 months prior to screening visit), psychotic disorder (current or lifetime), major depressive disorder with psychotic features, bipolar I with psychotic features, anorexia nervosa.
* Epilepsy (current or history). History of febrile childhood seizures and non-epileptic seizures are allowed.
* Pregnant or breast-feeding.
* Enrollment in clinical trial for any condition (current or within 60 days prior to screening visit).
* Hospitalization for any reason (current or past 2 weeks).
* Self-harming behaviors (current or within two years prior to screening visit).
* Higher than low suicide risk on the Columbia Suicide Severity Rating Scale (C-SSRS).
* Known cardiac abnormality or clinically significant heart disease.
* Anything that would make participation in the study unsafe or medically unadvisable in the assessment of a study clinician.

Contacts and Locations

Principal Investigator

Samantha Meltzer-Brody, MD

PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Study Locations (Sites)

Carolina Center for Neurostimulation

Chapel Hill, North Carolina, 27516

United States

Collaborators and Investigators

Sponsor: Electromedical Products International, Inc.

Samantha Meltzer-Brody, MD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

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 Date2024-01-26

Study Completion Date2026-03

Study Record Updates

Study Start Date2024-01-26

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms

Generalized Anxiety Disorder