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

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT02732561
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Depression; Anxiety	Device: Alpha Stim device; Device: Sham device	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Efficacy of Cranial Electrostimulating Therapy for Depression and Anxiety
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Depressive Symptoms [4 weeks]

   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.

2. Anxiety [4 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27117

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT02732561
• Other Study ID Numbers: IRB00036461
• First Posted: Apr 8, 2016
• Last Update Posted: Oct 16, 2018
• Last Verified: Sep 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Depression; Depressive Disorder; Anxiety Disorders

Study Results

Participant Flow

Arm/Group Title	Sham Device	Intervention
Arm/Group Description	Sham device Sham device: Sham device	CES device. cranial electrotherapy stimulation device. Alpha Stim device Alpha Stim device: cranial electrotherapy stimulation device
Period Title: Overall Study
STARTED	5	5
COMPLETED	3	4
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Sham Device	Intervention	Total
Arm/Group Description	Sham device Sham device: Sham device	CES device. cranial electrotherapy stimulation device. Alpha Stim device Alpha Stim device: cranial electrotherapy stimulation device	Total of all reporting groups
Overall Participants	5	5	10
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	5 100%	5 100%	10 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	1 20%	2 40%	3 30%
Male	4 80%	3 60%	7 70%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 40%	1 20%	3 30%
White	3 60%	4 80%	7 70%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Depressive Symptoms
Description	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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Only includes matched pairs

Arm/Group Title	Sham Device	Intervention
Arm/Group Description	Sham device Sham device: Sham device	CES device. cranial electrotherapy stimulation device. Alpha Stim device Alpha Stim device: cranial electrotherapy stimulation device
Measure Participants	3	4
Median (Full Range) [units on a scale]	13.00	6.50

2. Primary Outcome

Title	Anxiety
Description	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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

includes only matched pairs

Arm/Group Title	Sham Device	Intervention
Arm/Group Description	Sham device Sham device: Sham device	CES device. cranial electrotherapy stimulation device. Alpha Stim device Alpha Stim device: cranial electrotherapy stimulation device
Measure Participants	3	4
Median (Full Range) [units on a scale]	8.00	6.00

Adverse Events

Time Frame	from first patient, first visit to last patient, last visit. Approximately 2 months.
Arm/Group Title	Sham Device		Intervention
Arm/Group Description	Sham device Sham device: Sham device		CES device. cranial electrotherapy stimulation device. Alpha Stim device Alpha Stim device: cranial electrotherapy stimulation device
All Cause Mortality
	Sham Device		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)
Serious Adverse Events
	Sham Device		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Sham Device		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)

Limitations/Caveats

Data analyses done usually only matched pairs.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.