The Efficacy of Cranial Electrostimulating Therapy for Depression and Anxiety Among Homeless Adults

The Efficacy of Cranial Electrostimulating Therapy for Depression and Anxiety

This is a trial of the use of cranial electrostimulating therapy for depression and anxiety among homeless adults.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Device: Sham device; Device: Alpha Stim device

Detailed Description

Cranial Electrostimulating (CES) Therapy is a Food and Drug Administration (FDA) approved treatment for depression and anxiety. However, there are no known studies on the use of this device with homeless adults. The objectives of this study are as follows: 1) to evaluate the acceptability and feasibility of CES as a treatment for homeless adults; and 2) to evaluate the efficacy of CES for the treatment of anxiety and depressive symptoms among homeless adults. Participants will be randomly assigned to one of two treatments: sham (n=10) or CES (n=10). Changes in anxiety and depressive symptoms will be evaluated over time.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27117
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Competent (no legal guardian) males and females between the ages of 18 to 64
• Currently homeless or recent experience of homelessness, and symptoms of anxiety or depression

Exclusion Criteria:

• Younger than 18 and older than 65
• Patients who have attempted suicide with within the past twelve months or have active suicidal ideation will be excluded for possible safety concerns
• Self-reported illegal substance use in the past 30 days. Recent use of nicotine and alcohol will be allowed. However, those with current intoxication will be excluded
• History of a seizure disorder.
• Current history of autoimmune or endocrine disorder affecting the brain, unstable cardiac disease, history of skull fracture, or craniotomy
• Patients with pacemakers or internal electronic devices like deep brain stimulation and cochlear implants
• Women who are pregnant, nursing or planning to become pregnant
• Diagnosis of Schizophrenia or Schizoaffective disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Device; Sham device	Device: Sham device; Sham device
Active Comparator: Intervention; CES device. cranial electrotherapy stimulation device. Alpha Stim device	Device: Alpha Stim device; cranial electrotherapy stimulation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms	Hamilton Depression Rating Scale. The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression and as a guide to evaluate recovery (Hedlund, 1979). The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Assessment time is estimated at 20 minutes (Hamilton, 1960). Higher values represent a worse outcome. The HAM-D form lists 21 items, the scoring is based on the first 17.Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2, with a total score range of 0-50.	4 weeks
Anxiety	Hamilton Anxiety Rating Scale. The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety (Hamilton, 1959; McDowell, Newell & & McDowell, 2006). The scale consists of 14 items designed to assess the severity of a patient's anxiety. Each of the 14 items contains a number of symptoms, and each group of symptoms is rated on a scale of zero to four, with four being the most severe (with a total score range of 0-56). All of these scores are used to compute an overarching score that indicates a person's anxiety severity (Vaccarino, 2008). A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. Lastly, a score of 25 to 30 indicates a moderate to severe anxiety severity. Higher values represent a worse outcome.	4 weeks

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: James Kimball, MD, Wake Forest Health Sciences

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: April 4, 2016
• First Posted (Estimate): April 8, 2016

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: September 21, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: IRB00036461

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes