Use of Alpha-Stim Cranial-electrotherapy Stimulation (CES) in the Treatment of Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Is CES effective in the treatment of anxiety when accounting for any comorbid conditions and
      or current treatments including medication and psychotherapy.
    

Detailed description: 
      The goal of this study is to evaluate the efficacy of Alpha-Stim technology in the treatment
      of anxiety by using a double-blind clinical trial over a period of five weeks.
      Cranial-electrotherapy stimulation (CES) is a noninvasive procedure that has been used for
      decades in the United States to treat anxiety, depression, and insomnia. Although many
      studies on CES have been published in previous decades, most have used relatively small
      samples using various frequencies and links of treatment. Given the positive results of the
      many general studies that have been performed to date, this study seeks to add to the current
      literature by addressing previous criticisms using a large sample size (n=150)and using
      participants that represent more than a single type of anxiety along with comorbidity. Such a
      population is believed to better represent typical treatment complications.

      Participants will be recruited via advertisements in a local newspaper and posting of flyers
      around a local university campus. Participants will be screened through an intake process
      using the Structured Clinical Interview for Axis I Disorders (SCID-I) to confirm a diagnosis
      of an anxiety disorder. Comorbid conditions are acceptable, however, an anxiety disorder must
      be the primary diagnosis. As part of the intake process, participants will complete the
      Hamilton Anxiety Rating Scale (HAM-A)and the Hamilton Depression Rating Scale (HAM-D17) to
      establish a baseline. These instruments will serve as the primary efficacy measures. In order
      to participate, HAM-A scores must equal to or greater than 18 (Moderate Anxiety). Depression
      will be monitored using The HAM-D17 as depression is a commonly occurring condition with
      anxiety and the HAM-D17 is also sensitive to anxiety. Current treatment with medications are
      also acceptable provided there will be no changes in dosage or type during the study. See
      Inclusions and Exclusions for further information. All participants will pay a fee of $30 to
      enter the study to cover administration costs and as a way to measure placebo effect.
      Participants will be assigned a device to take home and self-administer treatment 5-7 days a
      week. Participants will be required to log their treatment times and dates with logs provided
      by the researcher. The student population will not be given a take home device but will
      receive treatment at the Graduate Assistant's Office or Student Care Office.

      Electromedical Products International, Inc. has agreed to supply the devices needed to carry
      out the research to include conductance solution, felt tabs, and batteries. Half of the
      devices will be set by the manufacturer to deliver treatment at 0.5 Hz and at the lowest
      therapeutic setting. The remaining devices will be shame and not deliver any therapeutic
      benefit. The devices will not be able to be altered by the participant.

      Participants will meet with the PI or research assistant to complete the HAM-A and HAM-D17 at
      weeks 1, 3, and 5 at a designated location either in the researchers private practice office
      or university lab location. Adverse treatment reactions will also be noted. Treatment logs
      will also be collected at these points. At weeks 1 and 3, participants will be given fresh
      batteries, conductance solution, and felt tabs as needed. At the completion of the study,
      participants found to be in the shame treatment group will be offered the normal course of
      treatment. Participants not wanting to continue the study or do not wish to follow through
      with normal treatment after being in the shame group will be refunded their fee.

      The hypothesis this study seeks to address is:

      H°: There is no difference between sham treatment and active CES on level of anxiety as
      compared to scores on the HAM-A and HAM-D17.

      H¹ : The active CES treatment group has significantly lower anxiety scores on the HAM-A and
      HAM-D17 than the sham group at the endpoint of the study.

      Statistical analysis will compare baselines scores (week 1) to midpoint scores (week, 3), and
      scores at the endpoint of the study (week 5). Response to treatment will be defined as an
      improvement of 30% or greater on the HAM-A and HAM-D17 at the endpoint of the study. The
      impact of prescription medication as a confounding variable in relation to the effect of CES
      on anxiety and depression will also be examined. Data analysis will consist of a repeated
      measures design that will likely use a general linear model in SPSS and hierarchical linear
      and quadratic growth models to assess individual change. The reason for this approach is that
      hierarchical analysis of individual change is advantageous when there are multiple repeated
      measure data patterns because it affords the research an opportunity to combine into a single
      analysis (Raudenbush & Byrk, 2002). We will estimate both the individual growth and mean
      growth for each point in the time series. Cross-validation of quadratic will occur via the
      estimation of a piecewise linear growth models to assess whether growth is more variable for
      one period over another during the study time frame.

      Optimal design software has been used to make a preliminary determination that 100 or more
      participants in a randomized quadratic growth individual change model will achieve a power of
      .80 to .95 for a study expecting an effect size of between 0.6 to .80, respectively (0.62 is
      premised upon meta-analysis for CES undertaken by Klawansky, et al., 1995 and .8 is
      considered a large effect by Cohen, 1988). We will employ power analysis again once sample
      size is confirmed following recruitment of participants and expect upwards of 150 or more
      participants. Missing data will be explained using an intent-to-treat analysis whereby we
      employ redundant analysis procedures (i.e., survival analysis) to understand and context the
      true treatment effect.
    

Intervention name(s): CES treatment using Alpha-Stim technology; Shame CES Treatment
Intervention type(s): Device; Device
Intervention description(s): Treatment involves the passage of micro current levels of electrical stimulation across the head via electrodes placed bilaterally on the ears. The current used in this device is no stronger than the current that naturally occurs in the human body. Treatment is delivered using a current equal to 0.5 Hz for a period of 60 mins. Treatment will be self-administered on a daily basis 5-7 days per week.The manufacturer of the device, Electro medical Products, Inc. will provide the devices for the study. They will alter the functional devices to deliver treatment at a therapeutic level of <1 mA. The current cannot be altered by the participant. Participants will be required to log the date, time, and duration of treatment. The logs will be provided by the PI and will be collected weekly. Participants will also be required to complete the Hamilton Anxiety Rating Scale (HAM-A) and the Hamilton Depression Rating Scale 17 (HAM-D17) at baseline and at weeks 1, 3, and 5.; Treatment will be self-administered on a daily basis 5-7 days per week.The manufacturer of the device, Electro medical Products, Inc. will provide the devices for the study. They will alter the devices so they cannot emit an electrical current. The ability for the device to emit a current cannot be altered by the participant. Participants will be required to log the date, time, and duration of treatment. The logs will be provided by the PI and will be collected weekly. Participants will also be required to complete the Hamilton Anxiety Rating Scale (HAM-A) and the Hamilton Depression Rating Scale 17 (HAM-D17) at baseline and at weeks 1, 3, and 5.
Other intervention name(s): Alpha-Stim; CES; Anxiety; Alpha-Stim; CES; Anxiety
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anxiety; Anxiety Disorders