Status:
COMPLETED
Effectiveness of CES on Emotional and Cellular Wellbeing
Lead Sponsor:
University of California, Los Angeles
Conditions:
Anxiety
Depression
Eligibility:
MALE
18-40 years
Phase:
NA
Brief Summary
The investigators aim to use a CES (cranial electrotherapy stimulation) intervention to improve emotional well-being by reducing symptoms of anxiety and depression and to assess for changes in markers...
Detailed Description
This study aims to test an auricular cranial electrotherapy stimulation (CES) device, Alpha-Stim, to assess for changes in markers of cellular health and emotional well-being improvement associated wi...
Eligibility Criteria
Inclusion
- Male
- Within the age range of 18-40 years old
- Score 8-14 on either the anxiety or depression HADS scale as defined as mild (8-10) to moderate (11-14)
- Subjects who receive anxiety, depression, psychiatric or mental health treatment (pharmacological or non-pharmacological) must be on a stable regimen for the past 3 months
- No active suicidal ideation or psychosis (including schizophrenia and bipolar disorder)
- No uncontrolled or progressive severe medical illness (e.g., cancer, uncontrolled diabetes mellitus, active cardiac disease)
- No use of a pacemaker or any other implanted electrical device
- No alcohol consumption greater than 2 units daily
- Ability to independently complete the in-person study questionnaires and sign informed consent form (ICF) without assistance
- Willing to comply with all study procedures and be available for the duration of the study
- No participation in another clinical trial study
Exclusion
- Not a male
- Younger than 18 years old or older than 40 years old
- Score ≥15 on either the anxiety or depression HADS scale as defined as severe (15-20)
- Subject who receive anxiety, depression, psychiatric or mental health treatment (pharmacological or non-pharmacological) who have not been on a stable regimen for the past 3 months
- Active suicidal ideation or psychosis (including schizophrenia and bipolar disorder)
- History of inpatient treatment or suicidal ideation within the last year
- Use of a pacemaker or any other implanted electrical device
- Unable to independently complete the in-person study questionnaires and sign ICF due to impaired cognitive function
- Unwilling to comply with all study procedures
- Unavailable for the duration of the study
- Current participation in another clinical trial study
- Any other condition that the investigator believes would jeopardize the safety or rights of the subject or would render the subject unable to comply with the study protocol or make use of acquired data non-analyzable
Key Trial Info
Start Date :
March 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2018
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03369418
Start Date
March 1 2016
End Date
October 20 2018
Last Update
August 19 2020
Active Locations (1)
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1
University of California, Los Angeles (UCLA)
Los Angeles, California, United States, 90025