Effectiveness of CES on Emotional and Cellular Wellbeing
Condition: Anxiety; Depression
MeSH terms: Depression
Study type: Interventional

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 of cellular health - specifically, telomere length and telomerase activity
    

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 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.
    

Intervention name(s): Alpha-Stim Active; Alpha-Stim Inactive
Intervention type(s): Device; Device
Intervention description(s): The study device is a safe, commercially available take-home cranial electrotherapy stimulation device that applies an electrical current to a subject's head to treat anxiety, depression or insomnia; The study device given to the inactive group will be identical to the active except the electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment