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

Wake Forest University (WFU)

Status: Completed

Conditions: Depression; Anxiety

Treatments: Device: Sham device; Device: Alpha Stim device

Study type: Interventional

Funder types: Other

Identifiers

NCT02732561

IRB00036461

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Sham Device

Sham Comparator group

Description:

Sham device

Treatment:

Device: Sham device

Intervention

Active Comparator group

Description:

CES device. cranial electrotherapy stimulation device. Alpha Stim device

Treatment:

Device: Alpha Stim device