About this trial
The study is to evaluate the feasibility of using a non-invasive brain stimulation device in a sample of inpatients with eating disorders (ED). The study will help researchers evaluate whether their device protocol is practical for eating disorder inpatients as a way to manage eating disorder and anxiety symptoms. A secondary aim of the study is to evaluate preliminary effectiveness of the protocol for reducing pre-meal anxiety during the treatment, and explore effects on eating disorder symptoms over the course of the inpatient admission.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-30 years old at the time of enrollment
Enrolled in Rogers Behavioral Health Eating Disorder Recovery Program Inpatient Unit at the Oconomowoc, WI clinic location
Have a primary diagnosis of any DSM-5 eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder, avoidant/restrictive food intake disorder, other specified feeding or eating disorder)
Ability to communicate effectively using written and spoken English
Disqualifiers
Metal in the body of any kind (e.g., braces, pacemakers, metal plates or screws, intracranial electrodes, implanted devices/defibrillators, prostheses)
Currently taking medication that reduces seizure threshold (e.g., clomipramine)
Cranial pathologies (e.g., holes, plates)
History of seizure or black-out concussion
Trial design
Single group
Treatments tested in this trial
Alpha-Stim AID
DeviceSubjects will receive non-invasive cranial electrotherapy stimulation (CES) treatment in 20-minute group sessions taking place immediately prior to breakfast, lunch, and dinner. This study uses the Alpha-Stim AID® CES device which will be set to the highest amplitude that is tolerated by the participant (with a minimum of 200 microampere (µA) and a maximum of 500 µA stimulation) at 0.5 hertz for a duration of 20 minutes per session, 3 sessions per day, for 3 separate days of stimulation (180 minutes of stimulation total).
Treatment groups
Trial outcomes
Primary outcomes
Percentage of patients who were recruited, enrolled and completed the study
The percentage of eligible patients approached for recruitment, percentage of recruited patients enrolled, and percentage of enrolled patients completing the study, each as recorded by study staff.
Patient-reported dropout reason
The patient's self-reported rationale for leaving the study prematurely (e.g., unexpected discharge from inpatient eating disorder treatment, unable to tolerate stimulation, emergent suicidality, unwilling to participate in the protocol, etc.).
Patient-reported side effects
Patient-reported side effects questionnaire assessing side effects experienced from the intervention day prior.
Patient perception of acceptability as assessed by the Credibility and Expectancy Questionnaire
The Credibility and Expectancy Questionnaire is a 6-item self-report survey used to assess patients' belief and expectation that they will benefit from a treatment. We will use two questions from the scale to assess how much the participant believes the treatment makes sense, and how strongly they feel it will help them. It is rated on a 10-point scale with anchors 1-9 (not at all (1), somewhat (5), very (9)). The two questions from the CEQ will be as follows: 1. How logical does cranial electrical stimulation for pre-meal anxiety seem? 2. How successful do you think cranial electrical stimulation will be in reducing your pre-meal anxiety?
Secondary outcomes
Pre-meal anxiety on a visual analogue scale on a scale from 0-10.
A patient-reported measure of pre-meal anxiety rated on a 0-10 visual analogue scale. A score of 0 is no anxiety while a score of 10 is maximum anxiety.
Eating Disorder Symptoms using the Eating Disorder-15 (ED-15) measure
Patient self-reports of eating disorder symptoms using the Eating Disorder-15 (ED-15) measure. The ED-15 includes two attitudinal subscales, scored as follows: 1) Weight \& Shape Concerns = mean of items 2, 4, 5, 6, 9, and 10 (add the six scores and divide by 6), 2) Eating Concerns = mean of items 1, 3, 7 and 8 (add the four scores and - divide by 4). The Overall attitudinal score is the mean of the scores on all ten items (total the ten items and divide by 10). All items are positively scored from 0-6.
The Fear of Food Measure (FOFM)
The Fear of Food Measure (FOFM) is a measure of the degree to which patients report fearing eating and food itself. Scores on the FOFM can assess if patients are improving while undergoing eating disorder treatment. The FOFM is a 23 item scale positively scored 0-5 with three attitudinal scales measuring Anxiety About Eating, Food Anxiety Behaviors (i.e., avoidance), and Feared Concerns (i.e., feared outcomes of eating). Scores on all subscales will be examined, but Food Anxiety Behaviors scores are the most directly comparable across eating disorder diagnoses (e.g., Avoidant Restrictive Food Intake Disorder (ARFID) vs. anorexia and bulimia nervosa, Other Specified Feeding or Eating Disorders (OSFED)).
Eating disorder clinical impairment rated on the Clinical Impairment Assessment - Eating only (CIA)
The Clinical Impairment Assessment - Eating only (CIA) is a 16-item measure of physical, cognitive, and emotional impairment from disordered eating. Items are scored on a 0-4 scale. The Eating-only version of the measure assesses impairment specifically related to restrictive or binge eating behavior, rather than impairment from other eating disorder behaviors that are not universally applicable to all eating disorders (i.e., purging, compensatory exercise). The measure is scored by summing all items for a possible score of 0-64.
Sponsors and contacts
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Rogers Behavioral Health
Lead sponsor
Electromedical Products International, Inc.
Collaborator