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

NCT ID: NCT02732561

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-06-30

Brief Summary

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

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.

Conditions

Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sham Device

Sham device

Group Type: SHAM_COMPARATOR

Sham device

Intervention Type: DEVICE

Sham device

Intervention

CES device. cranial electrotherapy stimulation device. Alpha Stim device

Group Type: ACTIVE_COMPARATOR

Alpha Stim device

Intervention Type: DEVICE

cranial electrotherapy stimulation device

Interventions

Alpha Stim device

cranial electrotherapy stimulation device

Intervention Type: DEVICE

Sham device

Sham device

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Kimball, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00036461

Identifier Type: -

Identifier Source: org_study_id