Depression Clinical Trial
Official title:
The Effect of Cranial Electrotherapy Stimulation on Emotional and Cellular Wellbeing
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 of cellular health - specifically, telomere length and telomerase activity
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 with anxiety and depression.
Returning Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) Veterans have a
high incidence of anxiety, depression, insomnia, post-traumatic stress disorder (PTSD) and
chronic pain, leading to reductions in emotional well-being. This type of chronic emotional
distress can lead to detrimental biological outcomes. We will compare as an exploratory
outcome Veterans vs. non-Veterans response to Alpha-Stim treatment. At the cellular level,
impairment of the telomere/telomerase system may be a result of this dysregulation, given the
descriptions of shorter telomeres (a marker of cellular aging), as well as increased markers
of inflammation in subjects with depression, anxiety and PTSD, compared to aged matched
healthy populations. These negative cellular effects of emotional distress have not been well
studied in this population and may offer significant benefit.
In one study of auricular CES using the same protocol proposed here, 115 patients with
anxiety or anxiety and comorbid depression were studied over 5 weeks in a randomized, sham
controlled trial, showing significant improvements in both anxiety and depression symptoms.
Due to the complexity of overlapping negative affect symptoms that lead to impaired emotional
well-being in Veterans, the investigators chose in this proposal to evaluate a composite
measure of emotional distress (a combined anxiety and depression score) as the primary
outcome. Beyond depression and anxiety, CES has been associated with reductions in insomnia
and pain, both of which are also significant problems in Veterans, likely contributing to
reduced emotional well-being.
Primarily all interested and appropriate study subjects will undergo a screening at the
University of California, Los Angeles (UCLA) G. Oppenheimer Center for Neurobiology of Stress
and Resilience (CNSR). The investigators expect to enroll and screen no less than 55 subjects
in order to complete 22 evaluable subjects for analysis in each treatment group.
The Hospital Anxiety and Depression Scale (HADS) will assess symptom severity defined as
normal range (0-7), mild (8-10), moderate (11-14) or severe (15-20). Subjects with impaired
emotional well-being with mild to moderate anxiety and/or depression on the HADS scale will
be included. Subjects with a maximum combined HADS score of 28 will be included. Subjects
treated for anxiety, depression, psychiatric or mental health treatment must be on a stable
regimen (pharmacological or non-pharmacological) for the past 3 months.
If eligible the study coordinator will contact them to schedule a screening visit at UCLA.
During this visit, the research team will conduct baseline measurements via study
questionnaires, history and physical exam, and a standardized psychiatric evaluation (MINI).
Subjects meeting the inclusion criteria will have training in use of the Alpha-Stim device
and will have their first 1 hour treatment. Subjects who tolerate the CES treatment will have
blood drawn for biological measures and will take the device home to use daily for 8 weeks.
Mid-study the subjects will come back to UCLA to complete questionnaires and have vital signs
and weight measured. At the end of the 8 weeks, subjects will return to UCLA, return the
device, have vital signs and weight measured, have the final blood draw, and complete a final
set of questionnaires.
All in all, to complete the study, subjects will have an initial screening, mid and final
study visit, pre, mid, and final study questionnaires, and blood drawn in the first and final
visit.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A |