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

NCT02732561 | Completed Results FDA Device

• 1 other identifier: IRB00036461
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Sham Device

SHAM COMPARATOR

Sham device

Device: Sham device

Intervention

ACTIVE COMPARATOR

CES device. cranial electrotherapy stimulation device. Alpha Stim device

Device: Alpha Stim device

Interventions

Alpha Stim device DEVICE

cranial electrotherapy stimulation device

Intervention

Sham device DEVICE

Sham device

Sham Device

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27117, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Limitations and Caveats

Data analyses done usually only matched pairs.

Results Point of Contact

• Title: James Kimball, MD
• Organization: Wake Forest Health Sciences

jkimball@wakehealth.edu

1 (336) 716-9702

Study Officials

• James Kimball, MD

  Wake Forest Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 8, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 16, 2018
• Results First Posted: May 1, 2017

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)