Non-invasive Cranial Electrical Stimulation for Mealtime Anxiety in Adults With Eating Disorders

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.

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 questionnaire assessing side effects experienced from the intervention day prior.

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:

• How logical does cranial electrical stimulation for pre-meal anxiety seem?
• How successful do you think cranial electrical stimulation will be in reducing your pre-meal anxiety?

Tracking and reporting completeness of all patient-reported outcome data and study data abstracted from electronic medical records.

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.

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) 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)).

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.

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.

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.