An interventional study of Alpha-Stim AID in Eating Disorders and Anxiety, sponsored by Rogers Behavioral Health. Recruiting at 1 site in United States. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Rogers Behavioral Health · Not applicable, Interventional, and Treatment
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.
Evaluate the feasibility and acceptability of a protocol for using Alpha-Stim AID® (explicitly references the patented waveform and delivery method in the Alpha-Stim AID® device manufactured and marketed by Electromedical Products International, Mineral Wells, TX) to manage acute pre-meal anxiety in eating disorder inpatients indicated by recruitment and retention, dropout reasoning, nature and frequency of patient-reported side effects, level of missing patient-reported data, staff perception and patient perception. Secondary outcomes include pre-meal anxiety rated on a 0-10 visual analogue scale, eating disorder symptom severity during the three-session protocol and across the inpatient admission using the Eating Disorder-15 assessment, and clinical impairment from disordered eating using the Clinical Impairment Assessment-Eating only version, across the same timepoints.
645 studies on the registry are indexed under Feeding and Eating Disorders; 153 are open to participants now.
This study's planned enrollment of 30 is below the median of 71 across 452 interventional studies indexed under Feeding and Eating Disorders.
Browse Feeding and Eating Disorders studies →Rogers Behavioral Health is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participant is eligible for mealtime anxiety support based on:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive treatment as usual and non-invasive cranial electrotherapy stimulation (CES) intervention using the Alpha-Stim AID device.
Device: Alpha-Stim AID
Subjects 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).
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.
Time frame: From recruitment to end of study intervention at day 3.
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.).
Time frame: Anytime from enrollment to the end of study intervention at day 3.
Patient-reported side effects
Patient-reported side effects questionnaire assessing side effects experienced from the intervention day prior.
Time frame: Before the first session on days 2 and 3 of the study intervention.
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?
Time frame: Baseline, Days 2 and 3 of study intervention.
Percent completion of study data collection
Tracking and reporting completeness of all patient-reported outcome data and study data abstracted from electronic medical records.
Time frame: At end of patient's participation and end of admission on inpatient unit.
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.
Time frame: Prior to each meal on intervention days 1, 2 and 3.
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.
Time frame: From enrollment until end of study intervention on day 3.
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)).
Time frame: At days 1, 2 and 3 of intervention.
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.
Time frame: Days 1, 2 and 3 of intervention.
Frequency of use of mealtime interventions for anxiety
Frequency of use of mealtime interventions for anxiety. This is a study-specific measure created by summing the meals during which one or more acute anxiety interventions (acute anxiolytics, one-to-one support, reduced meal plan, or tube feeding) were used across the full inpatient stay. Obtained from the electronic medical record.
Time frame: Inpatient admission to discharge (average 14 days)
Length of stay in days in the inpatient program
The outcome is time to discharge to a lower level of eating disorder care. This analysis will exclude data from any patient discharged for medical reasons, to another inpatient program, or against medical advice. Obtained from the electronic medical record.
Time frame: Inpatient admission to discharge (average 14 days).
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Nov 2027, 28 months after the start.
Of 269 non-industry interventional studies with no phase under Feeding and Eating Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 49. This study's planned 28 months is close to that.
Counting every sponsor, half of 274 studies reached it within 28 months; a quarter within 14 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
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