Investigating Non-invasive Cranial Electrotherapy Stimulation for Acute Anxiety in Inpatients With Eating Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patient-reported side effects
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Participant is eligible for mealtime anxiety support based on:
- •≤ 75% meal plan compliance
- •Visible anxiety/distress during program meals
- •Engagement in compensatory behaviors or self-harm before, during, or after meals, or medical staff judge patient to be at risk of same
排除标准
- •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
- •Risk of suicide/self-harm by self-strangulation with cranial electrotherapy stimulation (CES) device judged by study medical staff
- •Participant calibrates to a stimulation level below 200 microampere (μA)
研究组 & 干预措施
Alpha-Stim AID Intervention Arm
Subjects will receive treatment as usual and non-invasive cranial electrotherapy stimulation (CES) intervention using the Alpha-Stim AID device.
干预措施: Alpha-Stim AID (Device)
结局指标
主要结局
Patient-reported side effects
时间窗: Before the first session on days 2 and 3 of the study intervention.
Patient-reported side effects questionnaire assessing side effects experienced from the intervention day prior.
Percentage of patients who were recruited, enrolled and completed the study
时间窗: From recruitment to end of study intervention at day 3.
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
时间窗: Anytime from enrollment to the end of study intervention at day 3.
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 perception of acceptability as assessed by the Credibility and Expectancy Questionnaire
时间窗: Baseline, Days 2 and 3 of study intervention.
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?
Percent completion of study data collection
时间窗: At end of patient's participation and end of admission on inpatient unit.
Tracking and reporting completeness of all patient-reported outcome data and study data abstracted from electronic medical records.
次要结局
- Pre-meal anxiety on a visual analogue scale on a scale from 0-10.(Prior to each meal on intervention days 1, 2 and 3.)
- Frequency of use of mealtime interventions for anxiety(Inpatient admission to discharge (average 14 days))
- Length of stay in days in the inpatient program(Inpatient admission to discharge (average 14 days).)
- Eating Disorder Symptoms using the Eating Disorder-15 (ED-15) measure(From enrollment until end of study intervention on day 3.)
- The Fear of Food Measure (FOFM)(At days 1, 2 and 3 of intervention.)
- Eating disorder clinical impairment rated on the Clinical Impairment Assessment - Eating only (CIA)(Days 1, 2 and 3 of intervention.)